First-in-class Targeted Therapy in Oncology for Rare IDH1-Mutated AML and Cholangio-carcinoma.

Servier India introduces ‘Ivosidenib’ (Tibsovo®), in India, First-in-class Targeted Therapy in Oncology for Rare IDH1-Mutated AML and Cholangiocarcinoma. The introduction which was affirmed to be the First in this country is proving to be a path breaking miracle for the treatment of the dreadful Carcinoma (Cancer). It marks an important development in oncology, providing a treatment option for patients with AML and cholangiocarcinoma in India. Announced during AML Awareness month, highlighting Servier India’s ongoing efforts to support patients with rare and difficult-to-treat cancers.

Servier India, a subsidiary of the leading French pharmaceutical Servier Group, today announced the launch of Ivosidenib (Tibsovo®), an oral targeted therapy approved in the management of cancer patients with Acute Myeloid Leukaemia (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 leukaemia is a challenging haematological malignancy. Studies indicate that only about 30–40% of AML patients in India receive adequate treatment1, 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 manifests to the advanced stage.

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, Mr. 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 prioritising 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”.

What is noteworthy is the fact that IDH1 mutation occurs in approximately 7–14% of AML patients in India3, 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 calibre 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, Ms. 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”.

By introducing these advanced therapies, Servier India reaffirms its commitment to advancing innovative cancer treatments that improve clinical outcomes and enhance the quality of life of patients.

Servier India established in 1985 as an affiliate of the leading independent French pharmaceutical Servier Group focuses on therapeutic areas such as Cardiometabolism, Neuroscience, Venous Diseases, and Oncology.

Ivosidenib has already received regulatory approvals in more than 42 countries, including the USA, Europe, China, UAE, and South Korea. In the United States, the US FDA approved it in 2019 as a monotherapy and later in May 2022 as a combination treatment with Azacytidine for patients aged 75 and above, or those who cannot tolerate intensive chemotherapy. The European Medical Agency (EMA) gave its approval in May 2023 for use in patients who are not fit for standard induction chemotherapy.

In India, the process moved forward in April 2025, when the Subject Expert Committee (SEC) gave a positive recommendation for Ivosidenib. Following this, the DCGI granted approval for the marketing

authorisation in May 2025

Disclaimer: This News Article published by Maverick News 30 is intended solely to share regulatory and medical information regarding the launch; the reference to “Tibsovo” is not intended as a promotional or public advertisement. Use of the therapy is strictly based on a doctor’s prescription and clinical discretion.

Team Maverick