Servier India Private Limited Gets CDSCO Approval for Ivosidenib

Servier India Private Limited Gets CDSCO Approval for Ivosidenib. Servier India Private Limited has received approval from the CDSCO for Ivosidenib, marking a remarkable milestone in oncology treatment in India. This approval signifies a new ray of hope for patients suffering from Acute Myeloid Leukemia (AML) and Cholangiocarcinoma with IDH1 mutations, diseases that have long been considered difficult to treat with traditional therapies.
Background of Servier India Private Limited
Servier India Private Limited is a subsidiary of the French pharmaceutical group, Servier. Established in 1985, the company has been committed to improving patient lives through innovative pharmaceutical solutions. Over the past three decades, Servier India has focused on major therapeutic areas such as Cardiometabolism, Neuroscience, Venous Diseases, and Oncology.
With a strong workforce of around 580 employees, Servier India maintains a widespread presence across the country. The company’s mission revolves around bridging critical healthcare gaps and providing accessible treatments to patients in need. By launching Ivosidenib, Servier India has reaffirmed its dedication to introducing cutting-edge therapies that enhance patient outcomes and quality of life.
What is an Acute Myeloid Leukemia (AML)?
Acute Myeloid Leukemia (AML) is a type of blood cancer that originates in the bone marrow and progresses rapidly. It primarily affects the white blood cells, leading to abnormal cell proliferation. In India, AML poses a significant challenge, with data showing that only about 30–40% of patients receive appropriate treatment.
The high mortality rate associated with AML is often attributed to rapid disease progression and complications such as severe infections. Moreover, AML patients in India frequently face delays in diagnosis and treatment, further worsening survival outcomes. The availability of targeted therapies like Ivosidenib can potentially transform the treatment landscape for these patients.
What is Cholangiocarcinoma?
Cholangiocarcinoma is a rare and aggressive form of cancer that originates in the bile ducts. Due to its asymptomatic nature in the early stages, it is often diagnosed at advanced stages when the disease has already progressed significantly. This late detection greatly limits treatment options and reduces survival rates.
In India, cholangiocarcinoma is an emerging concern among oncologists as patients often present with advanced disease, resulting in limited effective treatment options. The introduction of targeted therapies provides a vital alternative, potentially improving outcomes for these patients.
Role of IDH1 Mutation
The IDH1 (isocitrate dehydrogenase-1) mutation plays a crucial role in the development of certain cancers, including AML and cholangiocarcinoma. In India, this mutation is observed in approximately 7–14% of AML cases. Identifying this mutation is essential for offering patients therapies tailored to their genetic profiles.
The IDH1 mutation leads to the production of an abnormal enzyme that disrupts normal cell metabolism and promotes cancer cell growth. Targeting this mutation offers a more precise approach, allowing treatment to attack cancer cells specifically while sparing healthy cells. This strategy represents a significant shift from traditional, broadly acting chemotherapies.
What is Ivosidenib?
Ivosidenib, marketed under the brand name Tibsovo, is an oral targeted therapy designed to treat cancers associated with the IDH1 mutation. By inhibiting the abnormal IDH1 enzyme, Ivosidenib helps restore normal cell differentiation and reduces cancer cell proliferation.
Internationally, Ivosidenib has received regulatory approval in more than 42 countries, including the United States, Europe, China, UAE, and South Korea. The US FDA first approved it in 2019 as a monotherapy and later in 2022 as a combination therapy with Azacitidine for elderly patients or those unable to tolerate intensive chemotherapy. The European Medical Agency (EMA) approved it in May 2023 for patients who are not suitable for standard induction chemotherapy.
Approval Journey in India
Servier India Private Limited has received approval from the CDSCO for Ivosidenib after a thorough and rigorous evaluation process. The journey began in April 2025 when the Subject Expert Committee (SEC) gave a positive recommendation for Ivosidenib. Following this, the Drug Controller General of India (DCGI) granted marketing authorization in May 2025.
The approval process involved detailed scrutiny of the drug’s clinical data, safety profile, and effectiveness in treating IDH1-mutated cancers. This milestone approval enables Servier India to import, sell, and distribute Ivosidenib across the country, offering a much-needed treatment option to eligible patients.
Importance of CDSCO Approval in India
Servier India Private Limited has received approval from the CDSCO for Ivosidenib, signifying the trust of Indian regulatory authorities in the drug’s safety and efficacy. The CDSCO approval represents a key achievement, enabling Indian patients to access a globally recognized targeted therapy. This approval aligns with the government’s mission to introduce advanced medical treatments and improve cancer care infrastructure. It also supports the broader strategy of making innovative therapies accessible and affordable to Indian patients.
Benefits of Ivosidenib for AML and Cholangiocarcinoma Patients
For AML patients with the IDH1 mutation, Ivosidenib offers a new treatment avenue that specifically targets the genetic alteration driving the disease. It provides an alternative to traditional chemotherapy, which is often associated with severe side effects and limited efficacy. In cholangiocarcinoma, where effective treatments have been scarce, Ivosidenib’s targeted approach offers hope for better disease management. By directly inhibiting the IDH1 mutation, the drug may help control disease progression and improve survival outcomes.
Patients receiving Ivosidenib may also experience improved quality of life due to the therapy’s oral administration and its potential to reduce the burden of hospital visits and invasive procedures.
Commitment to Access and Affordability
Servier India Private Limited has received approval from the CDSCO for Ivosidenib, but the company’s mission does not stop at approval. Servier India is actively working to ensure that this therapy is accessible and affordable to patients across the country. According to Ms. Pratima Tripathi, Commercial Director of Servier India, the company is collaborating with healthcare providers, patient advocacy groups, and policymakers to remove barriers to treatment access. This approach includes partnerships aimed at addressing financial challenges and improving timely availability of the drug.
The commitment to affordability underscores Servier’s patient-centric philosophy and dedication to making innovative therapies available to all who need them, irrespective of their economic status.
Improving Oncology Care in India
With the launch of Ivosidenib, Servier India Private Limited has taken a significant step towards advancing oncology care in India. The availability of a targeted therapy for AML and cholangiocarcinoma highlights the progress being made in precision medicine and personalized cancer treatments.
Dr. Pranav Sopory, Medical and Patient Affairs Director of Servier India, emphasized that Ivosidenib offers a new, effective option for healthcare professionals to improve patient outcomes, especially in cases where traditional treatments have failed.
This launch represents more than just a new drug; it signifies a broader transformation in cancer care that focuses on tailored treatments, enhanced survival rates, and improved quality of life.
Global Perspective on Ivosidenib
Servier India Private Limited has received approval from the CDSCO for Ivosidenib following global successes. In the United States and Europe, the drug has been used effectively as both monotherapy and combination therapy, setting a benchmark for targeted cancer treatment.
By aligning Indian treatment protocols with international standards, Servier India is ensuring that patients in India benefit from the latest scientific advancements and clinical evidence. Furthermore, the global success of Ivosidenib reinforces confidence among oncologists and patients regarding the drug’s efficacy and safety, supporting its adoption within Indian medical practice.
Servier’s Broader Mission and Vision
Servier India Private Limited has received approval from the CDSCO for Ivosidenib as part of its larger mission to improve healthcare outcomes through innovation and compassion. Servier Group, headquartered in France, operates in more than 150 countries and is guided by a Foundation committed to therapeutic progress.
Globally, Servier focuses on therapeutic areas including cardiometabolism, venous diseases, and oncology, with a strong emphasis on research and development. The group achieved a revenue of €5.9 billion in 2024, reflecting its robust global presence and dedication to advancing patient care. In India, Servier’s focus on oncology signifies a strategic move towards addressing rare and difficult-to-treat cancers. By introducing targeted therapies like Ivosidenib, Servier is contributing to the evolution of cancer treatment paradigms and paving the way for future innovations.
Collaborations and Partnerships After Receiving CDSCO Approval
Servier India Private Limited has received approval from the CDSCO for Ivosidenib and is actively fostering partnerships to ensure the therapy reaches patients who need it. These collaborations include working closely with oncologists, hospitals, patient organizations, and policy makers.
Such partnerships help to create awareness about the availability of new treatment options, facilitate early diagnosis of IDH1 mutations, and support patient navigation through treatment pathways. By working together, these stakeholders can collectively improve cancer care delivery and patient outcomes.
Impact on Patients and Families
For patients and their families, the availability of Ivosidenib represents a new chapter of hope and possibility. Many patients with AML and cholangiocarcinoma have historically faced limited treatment options and poor prognosis.
Servier India Private Limited has received approval from the CDSCO for Ivosidenib, allowing patients to access a therapy that is not only effective but also aligned with international standards of care. For families, this development brings comfort in knowing that advanced treatments are now available within India, reducing the need to travel abroad for specialized care. Additionally, the oral formulation of Ivosidenib offers convenience and may lessen the emotional and physical burden associated with traditional intravenous therapies.
Future for Cancer Treatment in India
The introduction of Ivosidenib sets a precedent for the future of cancer treatment in India. With Servier India leading the way in targeted therapies, more pharmaceutical companies may be encouraged to invest in precision medicine research and development.
Servier India Private Limited has received approval from the CDSCO for Ivosidenib, underscoring the importance of continuous innovation and the need for supportive policies to facilitate quicker drug approvals. As molecular testing and genetic profiling become more integrated into routine oncology care, the adoption of targeted therapies is expected to rise, improving survival rates and patient experiences across the country.
Conclusion
Servier India Private Limited has received approval from the CDSCO for Ivosidenib, marking a significant advancement in the Indian oncology landscape. This milestone reflects Servier India’s unwavering commitment to providing innovative and accessible treatment options to patients with rare and challenging cancers. With a strong focus on affordability, patient access, and partnerships, Servier India is not only transforming cancer care but also empowering patients and families with new possibilities and hope. The launch of Ivosidenib reinforces the importance of targeted therapy, precision medicine, and collaborative healthcare efforts in achieving better clinical outcomes and enhancing quality of life.
Through this introduction, Servier India continues to build on its legacy of scientific excellence and patient-centric care, driving progress towards a future where every cancer patient has access to the best possible treatment.
If you need any assistance in CDSCO Registration for Medical Devices in India, you can simply connect with Compliance Calendar LLP through mail at info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. What is Ivosidenib?
Ans. Ivosidenib is an oral targeted therapy designed to treat certain cancers that have a specific genetic change known as the IDH1 mutation. It works by blocking the abnormal enzyme caused by this mutation, which helps slow down or stop the growth of cancer cells. Servier India Private Limited has received approval from the CDSCO for Ivosidenib, making this innovative treatment available to patients in India.
Q2. Which cancers can be treated with Ivosidenib?
Ans. Ivosidenib is approved for the treatment of Acute Myeloid Leukemia (AML) and Cholangiocarcinoma in patients who have the IDH1 mutation. AML is a type of blood cancer, while Cholangiocarcinoma is a rare cancer that affects the bile ducts. Servier India Private Limited has received approval from the CDSCO for Ivosidenib specifically to target these challenging cancers.
Q3. What is the IDH1 mutation and why is it important?
Ans. The IDH1 mutation is a genetic change that causes an abnormal enzyme to develop in certain cancer cells, helping them grow and spread. It is found in about 7–14% of AML patients in India and is also seen in some Cholangiocarcinoma patients. Targeting this mutation makes treatments like Ivosidenib more precise and effective. Servier India Private Limited has received approval from the CDSCO for Ivosidenib, which directly addresses this mutation.
Q4. How is Ivosidenib taken by patients?
Ans. Ivosidenib is taken orally, meaning patients can take it as a tablet by mouth. This makes it more convenient than traditional intravenous therapies, which require hospital visits. Servier India Private Limited has received approval from the CDSCO for Ivosidenib to be used in this convenient oral form for eligible patients.
Q5. Why is the approval of Ivosidenib important for India?
Ans. The approval is important because it offers new hope to patients with limited treatment options. In India, many AML and Cholangiocarcinoma patients face poor survival rates due to late diagnosis and lack of effective therapies. Servier India Private Limited has received approval from the CDSCO for Ivosidenib to address this critical medical need and improve outcomes.
Q6. How was Ivosidenib approved in India?
Ans. The approval process involved careful evaluation by the Subject Expert Committee (SEC) and the Drug Controller General of India (DCGI). After a positive recommendation from the SEC in April 2025, the CDSCO granted final approval in May 2025. Servier India Private Limited has received approval from the CDSCO for Ivosidenib after this thorough scientific and safety review.
Q7. Is Ivosidenib available globally?
Ans. Yes, Ivosidenib has been approved in more than 42 countries, including the United States, Europe, China, UAE, and South Korea. Its international approvals reflect its safety and effectiveness. Servier India Private Limited has received approval from the CDSCO for Ivosidenib to make it available to Indian patients as part of a global standard of care.
Q8. Will Ivosidenib be affordable and accessible in India?
Ans. Yes. Servier India is working closely with doctors, patient groups, and policymakers to ensure the therapy is affordable and accessible. The company’s focus is to remove barriers so that more patients can benefit from this advanced treatment. Servier India Private Limited has received approval from the CDSCO for Ivosidenib with a strong commitment to accessibility.
Q9. What are the advantages of targeted therapy like Ivosidenib?
Ans. Targeted therapy focuses on specific genetic mutations in cancer cells, making it more precise than traditional chemotherapy. It usually causes fewer side effects and can improve survival rates and quality of life. Servier India Private Limited has received approval from the CDSCO for Ivosidenib to introduce this modern and effective approach to cancer care in India.
Q10. What does this approval mean for the future of cancer treatment in India?
Ans. This approval marks a significant step forward in cancer treatment in India. It shows that the country is moving towards advanced precision medicine and better patient care. Servier India Private Limited has received approval from the CDSCO for Ivosidenib, setting an example for future innovative cancer therapies that can save and improve more lives.

Servier India Private Limited has received approval from the CDSCO for Ivosidenib, marking a remarkable milestone in oncology treatment in India. This approval signifies a new ray of hope for patients suffering from Acute Myeloid Leukemia (AML) and Cholangiocarcinoma with IDH1 mutations, diseases that have long been considered difficult to treat with traditional therapies.

Background of Servier India Private Limited

Servier India Private Limited is a subsidiary of the French pharmaceutical group, Servier. Established in 1985, the company has been committed to improving patient lives through innovative pharmaceutical solutions. Over the past three decades, Servier India has focused on major therapeutic areas such as Cardiometabolism, Neuroscience, Venous Diseases, and Oncology.

With a strong workforce of around 580 employees, Servier India maintains a widespread presence across the country. The company’s mission revolves around bridging critical healthcare gaps and providing accessible treatments to patients in need. By launching Ivosidenib, Servier India has reaffirmed its dedication to introducing cutting-edge therapies that enhance patient outcomes and quality of life.

What is an Acute Myeloid Leukemia (AML)?

Acute Myeloid Leukemia (AML) is a type of blood cancer that originates in the bone marrow and progresses rapidly. It primarily affects the white blood cells, leading to abnormal cell proliferation. In India, AML poses a significant challenge, with data showing that only about 30–40% of patients receive appropriate treatment.

The high mortality rate associated with AML is often attributed to rapid disease progression and complications such as severe infections. Moreover, AML patients in India frequently face delays in diagnosis and treatment, further worsening survival outcomes. The availability of targeted therapies like Ivosidenib can potentially transform the treatment landscape for these patients.

What is Cholangiocarcinoma?

Cholangiocarcinoma is a rare and aggressive form of cancer that originates in the bile ducts. Due to its asymptomatic nature in the early stages, it is often diagnosed at advanced stages when the disease has already progressed significantly. This late detection greatly limits treatment options and reduces survival rates.

In India, cholangiocarcinoma is an emerging concern among oncologists as patients often present with advanced disease, resulting in limited effective treatment options. The introduction of targeted therapies provides a vital alternative, potentially improving outcomes for these patients.

Role of IDH1 Mutation

The IDH1 (isocitrate dehydrogenase-1) mutation plays a crucial role in the development of certain cancers, including AML and cholangiocarcinoma. In India, this mutation is observed in approximately 7–14% of AML cases. Identifying this mutation is essential for offering patients therapies tailored to their genetic profiles.

The IDH1 mutation leads to the production of an abnormal enzyme that disrupts normal cell metabolism and promotes cancer cell growth. Targeting this mutation offers a more precise approach, allowing treatment to attack cancer cells specifically while sparing healthy cells. This strategy represents a significant shift from traditional, broadly acting chemotherapies.

What is Ivosidenib?

Ivosidenib, marketed under the brand name Tibsovo, is an oral targeted therapy designed to treat cancers associated with the IDH1 mutation. By inhibiting the abnormal IDH1 enzyme, Ivosidenib helps restore normal cell differentiation and reduces cancer cell proliferation.

Internationally, Ivosidenib has received regulatory approval in more than 42 countries, including the United States, Europe, China, UAE, and South Korea. The US FDA first approved it in 2019 as a monotherapy and later in 2022 as a combination therapy with Azacitidine for elderly patients or those unable to tolerate intensive chemotherapy. The European Medical Agency (EMA) approved it in May 2023 for patients who are not suitable for standard induction chemotherapy.

Approval Journey in India

Servier India Private Limited has received approval from the CDSCO for Ivosidenib after a thorough and rigorous evaluation process. The journey began in April 2025 when the Subject Expert Committee (SEC) gave a positive recommendation for Ivosidenib. Following this, the Drug Controller General of India (DCGI) granted marketing authorization in May 2025.

The approval process involved detailed scrutiny of the drug’s clinical data, safety profile, and effectiveness in treating IDH1-mutated cancers. This milestone approval enables Servier India to import, sell, and distribute Ivosidenib across the country, offering a much-needed treatment option to eligible patients.

Importance of CDSCO Approval in India

Servier India Private Limited has received approval from the CDSCO for Ivosidenib, signifying the trust of Indian regulatory authorities in the drug’s safety and efficacy. The CDSCO approval represents a key achievement, enabling Indian patients to access a globally recognized targeted therapy. This approval aligns with the government’s mission to introduce advanced medical treatments and improve cancer care infrastructure. It also supports the broader strategy of making innovative therapies accessible and affordable to Indian patients.

Benefits of Ivosidenib for AML and Cholangiocarcinoma Patients

For AML patients with the IDH1 mutation, Ivosidenib offers a new treatment avenue that specifically targets the genetic alteration driving the disease. It provides an alternative to traditional chemotherapy, which is often associated with severe side effects and limited efficacy. In cholangiocarcinoma, where effective treatments have been scarce, Ivosidenib’s targeted approach offers hope for better disease management. By directly inhibiting the IDH1 mutation, the drug may help control disease progression and improve survival outcomes.

Patients receiving Ivosidenib may also experience improved quality of life due to the therapy’s oral administration and its potential to reduce the burden of hospital visits and invasive procedures.

Commitment to Access and Affordability

Servier India Private Limited has received approval from the CDSCO for Ivosidenib, but the company’s mission does not stop at approval. Servier India is actively working to ensure that this therapy is accessible and affordable to patients across the country. According to Ms. Pratima Tripathi, Commercial Director of Servier India, the company is collaborating with healthcare providers, patient advocacy groups, and policymakers to remove barriers to treatment access. This approach includes partnerships aimed at addressing financial challenges and improving timely availability of the drug.

The commitment to affordability underscores Servier’s patient-centric philosophy and dedication to making innovative therapies available to all who need them, irrespective of their economic status.

Improving Oncology Care in India

With the launch of Ivosidenib, Servier India Private Limited has taken a significant step towards advancing oncology care in India. The availability of a targeted therapy for AML and cholangiocarcinoma highlights the progress being made in precision medicine and personalized cancer treatments.

Dr. Pranav Sopory, Medical and Patient Affairs Director of Servier India, emphasized that Ivosidenib offers a new, effective option for healthcare professionals to improve patient outcomes, especially in cases where traditional treatments have failed.

This launch represents more than just a new drug; it signifies a broader transformation in cancer care that focuses on tailored treatments, enhanced survival rates, and improved quality of life.

Global Perspective on Ivosidenib

Servier India Private Limited has received approval from the CDSCO for Ivosidenib following global successes. In the United States and Europe, the drug has been used effectively as both monotherapy and combination therapy, setting a benchmark for targeted cancer treatment.

By aligning Indian treatment protocols with international standards, Servier India is ensuring that patients in India benefit from the latest scientific advancements and clinical evidence. Furthermore, the global success of Ivosidenib reinforces confidence among oncologists and patients regarding the drug’s efficacy and safety, supporting its adoption within Indian medical practice.

Servier’s Broader Mission and Vision

Servier India Private Limited has received approval from the CDSCO for Ivosidenib as part of its larger mission to improve healthcare outcomes through innovation and compassion. Servier Group, headquartered in France, operates in more than 150 countries and is guided by a Foundation committed to therapeutic progress.

Globally, Servier focuses on therapeutic areas including cardiometabolism, venous diseases, and oncology, with a strong emphasis on research and development. The group achieved a revenue of €5.9 billion in 2024, reflecting its robust global presence and dedication to advancing patient care. In India, Servier’s focus on oncology signifies a strategic move towards addressing rare and difficult-to-treat cancers. By introducing targeted therapies like Ivosidenib, Servier is contributing to the evolution of cancer treatment paradigms and paving the way for future innovations.

Collaborations and Partnerships After Receiving CDSCO Approval

Servier India Private Limited has received approval from the CDSCO for Ivosidenib and is actively fostering partnerships to ensure the therapy reaches patients who need it. These collaborations include working closely with oncologists, hospitals, patient organizations, and policy makers.

Such partnerships help to create awareness about the availability of new treatment options, facilitate early diagnosis of IDH1 mutations, and support patient navigation through treatment pathways. By working together, these stakeholders can collectively improve cancer care delivery and patient outcomes.

Impact on Patients and Families

For patients and their families, the availability of Ivosidenib represents a new chapter of hope and possibility. Many patients with AML and cholangiocarcinoma have historically faced limited treatment options and poor prognosis.

Servier India Private Limited has received approval from the CDSCO for Ivosidenib, allowing patients to access a therapy that is not only effective but also aligned with international standards of care. For families, this development brings comfort in knowing that advanced treatments are now available within India, reducing the need to travel abroad for specialized care. Additionally, the oral formulation of Ivosidenib offers convenience and may lessen the emotional and physical burden associated with traditional intravenous therapies.

Future for Cancer Treatment in India

The introduction of Ivosidenib sets a precedent for the future of cancer treatment in India. With Servier India leading the way in targeted therapies, more pharmaceutical companies may be encouraged to invest in precision medicine research and development.

Servier India Private Limited has received approval from the CDSCO for Ivosidenib, underscoring the importance of continuous innovation and the need for supportive policies to facilitate quicker drug approvals. As molecular testing and genetic profiling become more integrated into routine oncology care, the adoption of targeted therapies is expected to rise, improving survival rates and patient experiences across the country.

Conclusion

Servier India Private Limited has received approval from the CDSCO for Ivosidenib, marking a significant advancement in the Indian oncology landscape. This milestone reflects Servier India’s unwavering commitment to providing innovative and accessible treatment options to patients with rare and challenging cancers. With a strong focus on affordability, patient access, and partnerships, Servier India is not only transforming cancer care but also empowering patients and families with new possibilities and hope. The launch of Ivosidenib reinforces the importance of targeted therapy, precision medicine, and collaborative healthcare efforts in achieving better clinical outcomes and enhancing quality of life.

Through this introduction, Servier India continues to build on its legacy of scientific excellence and patient-centric care, driving progress towards a future where every cancer patient has access to the best possible treatment.

If you need any assistance in CDSCO Registration for Medical Devices in India, you can simply connect with Compliance Calendar LLP through mail at info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. What is Ivosidenib?

Ans. Ivosidenib is an oral targeted therapy designed to treat certain cancers that have a specific genetic change known as the IDH1 mutation. It works by blocking the abnormal enzyme caused by this mutation, which helps slow down or stop the growth of cancer cells. Servier India Private Limited has received approval from the CDSCO for Ivosidenib, making this innovative treatment available to patients in India.

Q2. Which cancers can be treated with Ivosidenib?

Ans. Ivosidenib is approved for the treatment of Acute Myeloid Leukemia (AML) and Cholangiocarcinoma in patients who have the IDH1 mutation. AML is a type of blood cancer, while Cholangiocarcinoma is a rare cancer that affects the bile ducts. Servier India Private Limited has received approval from the CDSCO for Ivosidenib specifically to target these challenging cancers.

Q3. What is the IDH1 mutation and why is it important?

Ans. The IDH1 mutation is a genetic change that causes an abnormal enzyme to develop in certain cancer cells, helping them grow and spread. It is found in about 7–14% of AML patients in India and is also seen in some Cholangiocarcinoma patients. Targeting this mutation makes treatments like Ivosidenib more precise and effective. Servier India Private Limited has received approval from the CDSCO for Ivosidenib, which directly addresses this mutation.

Q4. How is Ivosidenib taken by patients?

Ans. Ivosidenib is taken orally, meaning patients can take it as a tablet by mouth. This makes it more convenient than traditional intravenous therapies, which require hospital visits. Servier India Private Limited has received approval from the CDSCO for Ivosidenib to be used in this convenient oral form for eligible patients.

Q5. Why is the approval of Ivosidenib important for India?

Ans. The approval is important because it offers new hope to patients with limited treatment options. In India, many AML and Cholangiocarcinoma patients face poor survival rates due to late diagnosis and lack of effective therapies. Servier India Private Limited has received approval from the CDSCO for Ivosidenib to address this critical medical need and improve outcomes.

Q6. How was Ivosidenib approved in India?

Ans. The approval process involved careful evaluation by the Subject Expert Committee (SEC) and the Drug Controller General of India (DCGI). After a positive recommendation from the SEC in April 2025, the CDSCO granted final approval in May 2025. Servier India Private Limited has received approval from the CDSCO for Ivosidenib after this thorough scientific and safety review.

Q7. Is Ivosidenib available globally?

Ans. Yes, Ivosidenib has been approved in more than 42 countries, including the United States, Europe, China, UAE, and South Korea. Its international approvals reflect its safety and effectiveness. Servier India Private Limited has received approval from the CDSCO for Ivosidenib to make it available to Indian patients as part of a global standard of care.

Q8. Will Ivosidenib be affordable and accessible in India?

Ans. Yes. Servier India is working closely with doctors, patient groups, and policymakers to ensure the therapy is affordable and accessible. The company’s focus is to remove barriers so that more patients can benefit from this advanced treatment. Servier India Private Limited has received approval from the CDSCO for Ivosidenib with a strong commitment to accessibility.

Q9. What are the advantages of targeted therapy like Ivosidenib?

Ans. Targeted therapy focuses on specific genetic mutations in cancer cells, making it more precise than traditional chemotherapy. It usually causes fewer side effects and can improve survival rates and quality of life. Servier India Private Limited has received approval from the CDSCO for Ivosidenib to introduce this modern and effective approach to cancer care in India.

Q10. What does this approval mean for the future of cancer treatment in India?

Ans. This approval marks a significant step forward in cancer treatment in India. It shows that the country is moving towards advanced precision medicine and better patient care. Servier India Private Limited has received approval from the CDSCO for Ivosidenib, setting an example for future innovative cancer therapies that can save and improve more lives.