Servier India, a fully owned affiliate of the France-based Servier Group, has announced the launch of Ivosidenib (Tibsovo®)—a precision, first-in-class oral therapy, which is approved for the treatment of patients with IDH1-mutated Acute Myeloid Leukaemia (AML) and Cholangiocarcinoma. This milestone marks a critical step in expanding access to targeted cancer therapies in India, especially for rare and underserved cancer populations.

The launch comes after the Central Drugs Standard Control Organisation (CDSCO) granted import and marketing authorization on May 14, 2025, following a favorable recommendation from the Subject Expert Committee (SEC) in April.

Addressing Critical Gaps in Rare & Hard-to-Treat Onco Conditions 

AML and Cholangiocarcinoma continue to pose significant treatment challenges in India. AML, a rapidly progressing haematological malignancy, often goes undertreated—only around 30–40% of patients receive timely, adequate care, largely due to infection risk and fast disease progression. Cholangiocarcinoma, a rare cancer of the bile ducts, is frequently diagnosed at an advanced stage due to its subtle early symptoms.

Ivosidenib targets a specific genetic mutation—IDH1—which occurs in roughly 7–14% of AML cases in India, enabling a personalised therapeutic approach. The drug offers oncologists a much-needed treatment option where traditional chemotherapies show limited success, especially in patients not eligible for intensive induction regimens.

Strategic Launch During AML Awareness Month

The timing of the announcement aligns with AML Awareness Month, underscoring Servier India’s dedication to raising awareness and providing solutions for rare cancers. This precision therapy reflects a growing emphasis in Indian oncology on mutation-guided treatment pathways and personalised medicine.

Executive Perspectives

Aurélien Breton, Managing Director, Servier India, emphasised the organisation’s mission to democratize access to advanced therapies:

“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.”

Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India, highlighted the clinical relevance:

“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 at Servier India, stressed the focus on access and affordability:

“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.”

Global Footprint and Regulatory Background

Ivosidenib has already been approved in over 42 countries, including the United States, European Union, China, South Korea, and the UAE. In the US, the FDA approved it in 2019 as a monotherapy, and in 2022 in combination with Azacitidine for elderly or unfit AML patients. The EMA followed suit in 2023, extending its availability across Europe.

Also read: Policybazaar launches ‘Saarthi’: Elder care concierge program to address India’s senior healthcare gap

Servier’s Commitment to Oncology in India

With its footprint in India since 1985, Servier has steadily expanded its portfolio beyond cardiometabolism and neuroscience to include oncology. Globally, Servier is investing heavily in research for rare cancers, with oncology accounting for a growing share of its R&D pipeline.

This new launch reflects Servier India’s broader vision to advance precision oncology and partner with Indian stakeholders in strengthening cancer care infrastructure and access.

Disclaimer: This article is for informational & educational purposes only. The availability and use of Ivosidenib (Tibsovo®) are subject to physician discretion, regulatory guidelines, and prescription requirements. This is not a promotional communication.

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