Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive.
Prestige Biopharma Ltd. is mounting efforts to rise rank through the industry with a two-pronged strategy of becoming a global cancer antibody drug developer and contract development and manufacturing organization.
China’s NMPA approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
Another collaboration between two biopharmaceutical companies in the Asia-Pacific region is adding fuel to an already heated fire for antibody-drug conjugate (ADC) development worldwide. Suzhou, China-headquartered Genequantum Healthcare Co. Ltd. and South Korea’s Aimedbio Inc. recently announced extending an existing partnership to jointly develop five ADC investigative drugs.
From Roche Holding AG to Novartis AG, bad news abounds for anti-TIGIT immunotherapies. In an SEC filing on July 11, Chinese oncology R&D firm Beigene Ltd. and Basel, Switzerland-based Novartis announced an end to their $1 billion deal to develop the former’s TIGIT immunotherapy ociperlimab, with the checkpoint inhibitor going back to Beigene.
Elevar Therapeutics Inc. said that the U.S. FDA accepted its NDA for oral tyrosine kinase inhibitor rivoceranib in combination with PD-1 inhibitor camrelizumab (Airuika) as a first-line treatment for liver cancer. The FDA stamped an official PDUFA target action date of May 16, 2024.
On the heels of a licensing deal last week, Genequantum Healthcare Co. Ltd. has struck another deal, this time out-licensing its conjugation technology to Inxmed Co. Ltd. to support development of next-generation targeted antibody-drug conjugates (ADCs).
China’s Center for Drug Evaluation has cleared Jacobio Pharmaceuticals Group Co. Ltd.’s KRAS G12C inhibitor, glecirasib (JAB-21822), to begin a phase III pivotal study for pancreatic cancer.
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments.
Lotte Biologics Co. Ltd. said it partnered with domestic bioventure Kanaph Therapeutics Inc. to develop an antibody-drug conjugate (ADC) technology platform in hopes of rounding out a full, in-house ADC value-chain.
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