June 8, 2025

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Servier India introduces ‘Ivosidenib’ (Tibsovo®), in India, First-in-class Targeted Therapy in Oncology for Rare IDH1-Mutated AML and Cholangiocarcinoma• 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 Leukemia (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 leukemia is a challenging hematological malignancy. Studies indicate that only about 30–40% of AML patients in India receive adequate treatment, 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 is advanced.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 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.”IDH1 mutation occurs in approximately 7–14% of AML patients in India, 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 caliber 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. Disclaimer: This press release 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.About Servier India Servier India has been committed for over three decades to delivering innovative pharmaceutical solutions that improve the lives of patients and their families across India. Established in 1985 as an affiliate of the leading independent French pharmaceutical Servier Group, the company focuses on therapeutic areas such as Cardiometabolism, Neuroscience, Venous Diseases, and Oncology. Servier India has a strong pan-India presence and a dedicated workforce of around 580 that strives to address critical healthcare challenges with passion and purpose.As part of Servier group operating in over 150 countries, Servier India inherits a rich legacy of scientific excellence and patient-centric innovation. Globally, Servier invests heavily in research and development, focusing on our key therapeutic areas. About Servier Servier is a global pharmaceutical group governed by a Foundation that aspires to serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. As a world leader in cardiometabolism and venous diseases, Servier’s ambition is to become a focused and innovative player in oncology by targeting rare cancers. Headquartered in France, Servier relies on a strong geographical footprint; its medicines are available in close to 140 countries. The group achieved a revenue of €5.9 billion in 2024.Additional Details on IvosidenibInternationally, 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 Azacitidine 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 authorization in May 2025

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