Servier India launches Tibsovo® – First-in-class targeted therapy for rare IDH1-mutated AML & cholangiocarcinoma

New Delhi: Servier India, a subsidiary of the leading French pharmaceutical Servier Group, has announced the launch of Ivosidenib (Tibsovo®), an oral targeted therapy approved in the management of cancer patients with Acute Myeloid Leukemia (AML) and Cholangiocarcinoma, with an isocitrate dehydrogenase-1 (IDH1) mutation. Servier India received the approval on 14th May 2025, from Central Drugs Standard Control Organisation (CDSCO) for the import, sale, and distribution of the medication.

Acute myeloid leukemia is a challenging hematological malignancy. Studies indicate that only about 30–40% of AML patients in India receive adequate treatment, with high mortality rates due to rapid disease progression and infections. Cholangiocarcinomas (CCA) are rare tumours originating from bile duct. Due to their asymptomatic nature they are usually diagnosed when the disease is advanced.

The announcement marks a significant advancement in management of the mentioned rare and difficult-to-treat cancers in India, addressing a critical unmet medical need.

Speaking on the occasion, 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 prioritizing 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.”

IDH1 mutation occurs in approximately 7–14% of AML patients in India, making targeted mechanisms especially relevant for this subset.

“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 caliber of innovation in enhancing lives and advancing cancer care in India.”, highlighted Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India.

Speaking on the importance of treatment access, Pratima Tripathi, Commercial Director, Servier India, said: “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.”