Servier India, the Indian arm of the global French pharmaceutical leader Servier Group, has announced the launch of Ivosidenib (Tibsovo®)—a precision oral therapy approved for the treatment of Acute Myeloid Leukemia (AML) and Cholangiocarcinoma in patients with an IDH1 mutation. The approval, granted by the Central Drugs Standard Control Organisation (CDSCO) on May 14, 2025, allows the import, sale, and distribution of the medication across India.
AML is a fast-progressing blood cancer with high mortality, and studies suggest that only 30–40% of AML patients in India receive adequate treatment, often due to rapid disease progression and infections. Cholangiocarcinoma (CCA), a rare and aggressive cancer of the bile ducts, is usually diagnosed at advanced stages due to its asymptomatic nature. The availability of Tibsovo® brings much-needed hope to patients battling these difficult-to-treat cancers.
“This launch is a major step in our mission to bring innovative, precision-driven cancer treatments to Indian patients,” said Aurélien Breton, Managing Director, Servier India. “We are committed to improving access and affordability so that these critical therapies reach those who need them most. Our goal is to support clinicians and improve survival outcomes and quality of life.”
IDH1 mutations are seen in 7–14% of AML patients in India, making targeted therapies like Ivosidenib especially impactful. The therapy selectively inhibits the mutated IDH1 enzyme, helping to restore normal cell differentiation and offering a new line of treatment where conventional therapies often fall short.
“This therapy offers a valuable treatment option for both AML and CCA patients,” added Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India. “It underscores the importance of precision medicine in improving outcomes for patients with specific genetic profiles.”
Pratima Tripathi, Commercial Director, emphasized accessibility: “We are collaborating with healthcare providers, patient advocacy groups, and policymakers to ensure timely and equitable access to this therapy across India.”
With the launch of Ivosidenib, Servier India continues to strengthen its commitment to transforming cancer care in India through innovation, targeted treatment, and patient-centered solutions.