Servier India announced the launch of Ivosidenib (Tibsovo®), marking the introduction of India's first oral targeted therapy specifically designed for cancer patients with acute myeloid leukemia (AML) and cholangiocarcinoma harboring isocitrate dehydrogenase-1 (IDH1) mutations. The Central Drugs Standard Control Organisation (CDSCO) granted approval on May 14, 2025, for the import, sale, and distribution of this precision medicine.
Addressing Critical Treatment Gaps
The launch addresses significant unmet medical needs in India's oncology landscape. Studies indicate that only 30-40% of AML patients in India receive adequate treatment, with high mortality rates attributed to rapid disease progression and infections. Cholangiocarcinomas, rare tumors originating from bile ducts, present additional challenges due to their asymptomatic nature, typically resulting in advanced-stage diagnoses.
IDH1 mutations occur in approximately 7-14% of AML patients in India, making targeted therapeutic mechanisms particularly relevant for this patient subset. "Our focus is to advance oncology care by bringing innovative, precision medicines to patients who need them the most," said Aurelien Breton, Managing Director of Servier India. "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."
Global Regulatory Success and Clinical Evidence
Ivosidenib has demonstrated robust international acceptance, receiving regulatory approvals in more than 42 countries, including the United States, Europe, China, UAE, and South Korea. The US FDA initially approved the therapy in 2019 as a monotherapy, subsequently expanding approval in May 2022 for combination treatment with Azacitidine for patients aged 75 and above or those unable to tolerate intensive chemotherapy. The European Medical Agency (EMA) granted approval in May 2023 for patients not suitable for standard induction chemotherapy.
Dr. Pranav Sopory, Medical and Patient Affairs Director at Servier India, emphasized the therapeutic significance: "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."
Market Access and Affordability Initiatives
Servier India has prioritized ensuring broad patient access to the therapy across the country. "Our foremost priority is to ensure that the therapy is accessible and affordable to patients across India," stated Pratima Tripathi, Commercial Director at Servier India. "We are actively collaborating with healthcare providers, patient advocacy groups, and policymakers to remove barriers and facilitate timely access to this important therapy."
The regulatory pathway in India progressed through the Subject Expert Committee (SEC), which provided a positive recommendation for Ivosidenib in April 2025, followed by the Drug Controller General of India (DCGI) granting marketing authorization in May 2025.
Company Background and Strategic Focus
Servier India, established in 1985 as an affiliate of the French pharmaceutical Servier Group, has maintained a three-decade commitment to delivering innovative pharmaceutical solutions across India. The company operates with a workforce of approximately 580 employees and focuses on therapeutic areas including cardiometabolism, neuroscience, venous diseases, and oncology.
The parent company, Servier Group, operates in over 150 countries and achieved revenue of EUR 5.9 billion in 2024. As a world leader in cardiometabolism and venous diseases, Servier aims to become a focused and innovative player in oncology by targeting rare cancers.
