Springworks Therapeutics Inc. plans to file an NDA for its lead drug candidate, nirogacestat, for treating desmoid tumors later this year, as top-line data from a pivotal phase III trial indicate that it provided patients with a substantial progression-free survival benefit.
Turning Point Therapeutics Inc. has picked up near-global rights to develop and commercialize an antibody drug conjugate (ADC) targeting Claudin18.2 from Lanova Medicines Ltd. for $25 million up front. The deal excludes greater China and South Korea.
Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
Variable expression of an enzyme in the initial tumor has been identified as an early step in the process of migration and growth of cells to form remote metastases in breast cancer.
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