Servier India launches IDH1-targeted therapy Ivosidenib for AML and Cholangiocarcinoma

Servier India, a subsidiary of the French pharmaceutical group Servier, has announced the launch of Ivosidenib (Tibsovo), an oral targeted therapy approved for patients with Acute Myeloid Leukaemia (AML) and Cholangiocarcinoma carrying the isocitrate dehydrogenase-1 (IDH1) mutation. The Central Drugs Standard Control Organisation (CDSCO) granted approval for the import, sale, and distribution of the drug on 14 May 2025.

Acute Myeloid Leukaemia is a haematological malignancy with limited treatment coverage in India. According to available data, only 30–40 per cent of AML patients in the country receive appropriate therapy. High mortality is commonly associated with rapid disease progression and complications such as infections. Cholangiocarcinoma, a rare cancer of the bile duct, is often diagnosed at advanced stages due to a lack of early symptoms.

The launch introduces a targeted option for patients with an IDH1 mutation. This genetic alteration is observed in approximately 7–14 per cent of AML cases in India, making therapies like Ivosidenib relevant for a distinct patient segment.

Aurélien Breton, Managing Director, Servier India, said, “Our focus is to advance oncology care by bringing innovative, precision medicines to patients who need them the most. By prioritising access and working to make treatment options affordable to patients, we are dedicated to bridging critical gaps in cancer care across the country. This launch is a significant step forward in our mission to support healthcare providers with targeted treatment options and ultimately improve survival outcomes and quality of life for patients throughout India.”

Dr Pranav Sopory, Medical and Patient Affairs Director, Servier India, commented, “This therapy represents a significant therapeutic option in the treatment of AML and Cholangiocarcinoma. For healthcare professionals, this precision therapy offers a new, effective option that can improve patient outcomes where traditional treatments have limited success. It highlights the benefits of targeted therapy and calibre of innovation in enhancing lives and advancing cancer care in India.”

Pratima Tripathi, Commercial Director, Servier India, added, “Our foremost priority is to ensure that the therapy is accessible and affordable to patients across India. We are actively collaborating with healthcare providers, patient advocacy groups, and policymakers to remove barriers and facilitate timely access to this important therapy. Through these partnerships, we are committed to expanding treatment options and making a meaningful difference in the lives of patients.”

With this launch, Servier India continues its focus on increasing availability of targeted cancer therapies and supporting treatment access across healthcare systems.