Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies. No additional efficacy or safety data has been requested.
Confo Therapeutics NV closed out March in much the same way as it began the month – with a deal. The Ghent, Belgium-based company has entered a collaboration agreement with Daiichi Sankyo Co. Ltd. to generate brain-penetrant small-molecule agonists to an undisclosed G protein-coupled receptor (GPCR) implicated in central nervous system diseases.
In a show of commitment to Innate Pharma SA’s antibody-based natural killer cell engager therapeutics (Anket) platform, longstanding partner Sanofi SA is paying €25 million (US$26.5 million) up front and could pay up to €1.35 billion more in preclinical, clinical, regulatory, and commercial milestones for up to three development programs. Innate also stands to receive royalties on eventual product sales.
“We look at Japan with some envy with what they’ve been able to achieve and their approach to regenerative medicine, which has been supported significantly by their federal government,” said Silvio Tiziano, CEO of the Center for the Commercialization of Regenerative Medicine Australia, during the recent Ausbiotech conference in Perth.
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
The U.S. FDA has 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.
Daiichi Sankyo Co. Ltd.’s quizartinib met the primary endpoint of overall survival in the pivotal phase III Quantum-First study, which tested the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD-positive acute myeloid leukemia (AML).
