Servier India, a subsidiary of the renowned French pharmaceutical company Servier Group, has launched Ivosidenib (Tibsovo®)—an oral targeted therapy approved for treating patients with Acute Myeloid Leukemia (AML) and Cholangiocarcinoma (CCA) harboring an isocitrate dehydrogenase-1 (IDH1) mutation. The Central Drugs Standard Control Organisation (CDSCO) granted approval for the import, sale, and distribution of the drug on May 14, 2025.
Addressing Unmet Needs in Cancer Care
Acute Myeloid Leukemia remains a challenging blood cancer in India, with only 30–40% of patients receiving adequate treatment. Rapid disease progression and infections contribute to high mortality rates. Meanwhile, Cholangiocarcinoma, a rare cancer of the bile duct, often goes undiagnosed until the advanced stages due to its asymptomatic onset. These realities underscore the urgent need for more precise and effective treatment options.
A Step Forward in Precision Oncology
Highlighting the company’s vision, Mr. Aurélien Breton, Managing Director, Servier India, stated:
“Our focus is to advance oncology care by bringing innovative, precision medicines to patients who need them the most. By prioritizing access and affordability, we aim to close the critical gaps in cancer care across the country. The launch of Tibsovo® marks a major milestone in our mission to improve survival outcomes and quality of life for patients in India.”
Notably, IDH1 mutations are present in approximately 7–14% of AML patients in India, making targeted therapies like Ivosidenib especially relevant for this subset.
Expert Endorsement from Medical Leadership
As per the press release, Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India, emphasized the clinical value of the drug:
“This therapy offers a much-needed treatment option in AML and Cholangiocarcinoma, especially where traditional treatments have shown limited success. It demonstrates the power of targeted therapies to enhance outcomes and represents a new frontier in precision oncology.”
Ensuring Access and Affordability
Reinforcing Servier’s commitment to patient-centric care, Ms. Pratima Tripathi, Commercial Director, Servier India, said:
“We are actively working with healthcare professionals, patient advocacy groups, and policymakers to remove access barriers. Our primary goal is to ensure this therapy reaches every eligible patient who needs it. Through collaborative partnerships, we are expanding treatment access and striving to make a meaningful impact in the cancer care landscape.”
A Commitment to Transforming Cancer Outcomes in India
With the launch of Tibsovo®, Servier India reaffirms its commitment to delivering cutting-edge oncology solutions. The company continues to invest in scientific innovation and accessibility. It also focuses on strategic collaboration to improve clinical outcomes and quality of life for cancer patients across the country.