A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
Ideaya Biosciences Inc. has nominated IDE-251, a dual KAT6/7 inhibitor targeting 8p11 amplification tumors in breast and lung cancers, as a development candidate. IDE-251 is an equipotent, highly selective, small-molecule dual inhibitor of KAT6 and -7, both of which have been shown to support cancer cell survival.
Glutathione S-transferase (GSTP) is an enzyme involved in the detoxification of several xenobiotics such as tobacco carcinogens or cisplatin drugs and is overexpressed in KRAS-mutant lung, colon and pancreatic cancer, among others. The upregulation of GSTP may partially contribute to chemotherapy and radiotherapy resistance.
Mixed results for three of Bicycle Therapeutics plc’s zelenectide pevedotin development programs preceded a strong drop in the company’s stock. Bicycle shares (NASDAQ:BCYC) dropped 31.3% on Dec. 13 to close at $13.81 each, the stock’s lowest price in the past 12 months.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Merus NV gained accelerated U.S. FDA approval of Bizengri (zenocutuzumab) as the first and only targeted therapy indicated for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease. The approval came about seven months after the FDA accepted the BLA for filing under priority review, and two months ahead of the PDUFA goal date of Feb. 4, 2025, which had been extended by three months in November as the agency reviewed CMC information submitted in response to its request.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
