India Pharma Outlook Team | Saturday, 07 June 2025
Servier India, the Indian subsidiary of French multinational pharmaceutical company Servier Group, has rolled out Ivosidenib, an oral targeted treatment for IDH1-mutated acute myeloid leukaemia (AML) and cholangiocarcinoma (CCA) patients. It got the Central Drugs Standard Control Organisation (CDSCO) approval on 14 May, 2025. The medicine is ushering in a new era of precision oncology for India's rare, hard-to-treat cancers.
Improves survival where conventional treatments have limited impact
Ivosidenib is approved in 42-plus countries, including the US, the EU, and China
Ivosidenib addresses a significant unmet requirement in IDH1-mutated patients, who constitute nearly 7–14 percent of AML in India. As in the country, only 30–40 percent of AML patients are treated on time, and as cholangiocarcinoma tends to get diagnosed late in the majority, since it is asymptomatic, this particular treatment would significantly improve outcomes as well as survival.
Aurélien Breton, Servier India Managing Director, pointed to the company's commitment to delivering new medicines as widely available as possible while announcing the launch as evidence of their vision to support health professionals and patients with available and effective solutions. Similarly, Dr. Pranav Sopory, Director of Medical and Patient Affairs, emphasized the significance of the therapy as a means of offering clinicians an alternative where conventional ones have proved less than successful.
Servier's commitment to accessibility was also echoed by Commercial Director Pratima Tripathi, emphasizing alignment of the company with doctors, patient organizations, and policymakers to bring its medicines to the patients and provide timely access across India.
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Internationally, Ivosidenib was approved in over 42 countries across the globe, such as the US, Europe, China, the UAE, and South Korea. It received the approval of the US FDA in 2019, and subsequently, in 2022, it was also approved to be used with Azacitidine in non-intensive chemotherapy candidates. The European Medicines Agency (EMA) also approved it in 2023.
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