• 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

Mumbai, India, June 05, 2025 : 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 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 is advanced.2

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 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 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 Ivosidenib

Internationally, 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