Takeda signs option agreement with Ascentage Pharma to enter into exclusive global license for Olverembatinib
Japan: Takeda has announced the signing of an option agreement with Ascentage Pharma to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
Despite the impact TKIs have had in the treatment of patients with CML, there remains 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 important treatment advances for patients, particularly those with hematological cancers facing treatment gaps,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “We are highly encouraged by the promising results olverembatinib has shown in the clinic to date and excited to have the opportunity to potentially further develop and deliver it to patients with chronic myeloid leukemia and other hematological cancers. This agreement aligns with our goal to support the advancement of both internal and external innovation to best serve patients.”
Olverembatinib is an oral, third-generation BCR-ABL tyrosine kinase inhibitor (TKI). Olverembatinib is currently approved and marketed in China for the treatment of adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (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. Ascentage Pharma is investigating olverembatinib in multiple clinical studies in several types of cancer. Olverembatinib 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).
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