Monday, July 15, 2024

Chronic Myeloid Leukemia Treatment Advances: Takeda’s Exclusive Deal for Olverembatinib

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Takeda has signed an option agreement with Ascentage Pharma to enter into an exclusive license for olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML). This agreement grants Takeda the exclusive option to license global rights to olverembatinib in all territories outside mainland China, Hong Kong, Macau, Taiwan, and Russia. Olverembatinib has shown potential to address significant unmet needs for patients with chronic myeloid leukemia following treatment with currently approved TKIs.

Despite the impact of existing TKIs on CML treatment, there remains a significant unmet need for patients whose disease is resistant or refractory to these therapies or who develop hard-to-treat mutations following these treatments. Takeda has a long history of driving treatment advances for patients with hematological cancers facing treatment gaps. The promising results olverembatinib has shown in clinical trials are encouraging, and Takeda is excited to develop potentially further and deliver it to patients with CML and other hematological cancers.

Takeda and Ascentage Pharma Partner on Chronic Myeloid Leukemia Treatment Olverembatinib Development

As part of the agreement, Ascentage Pharma will continue to be solely responsible for all clinical development of olverembatinib before the potential exercise of the option to license. Olverembatinib is currently approved and marketed in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation and in adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs.

Takeda aims to support the advancement of both internal and external innovations to best serve patients. The global commercial expertise of Takeda, combined with Ascentage Pharma’s development efforts, could potentially broaden the impact of olverembatinib on patients in need around the world. Ascentage Pharma is progressing the development of olverembatinib in POLARIS-2, the global Phase 3 study in previously treated adult patients with CP-CML with or without the T315I mutation.

Under the terms of this agreement, Ascentage Pharma will receive an option payment of $100 million upon signing the exclusive option to license agreement. They will also be eligible for an option exercise fee and additional potential milestone and royalty payments if Takeda exercises the option to license olverembatinib. The exercise of the option is subject to customary regulatory approvals, and Ascentage Pharma will receive a minority equity investment from Takeda.

Chronic Myeloid Leukemia

A Promising Third-Generation Chronic Myeloid Leukemia Therapy Backed by Takeda’s Vision

Olverembatinib is an oral, third-generation BCR-ABL tyrosine kinase inhibitor. It has been granted orphan drug designation and Fast Track designation by the U.S. Food and Drug Administration (FDA) and orphan designation by the European Medicines Agency (EMA). Olverembatinib is being investigated in multiple clinical studies for several types of cancer, indicating its broad potential beyond CML.

Takeda is focused on creating better health for people and a brighter future for the world. They aim to discover and deliver life-transforming treatments in core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. With a dynamic and diverse pipeline, Takeda seeks to improve patient experiences and advance new treatment options. Guided by their commitment to patients, their people, and the planet, Takeda’s employees in approximately 80 countries and regions are driven by their purpose and values.


Resource: Takeda, June 14, 2024

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