- In February 2025, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a potential first-line treatment for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA has granted the application Breakthrough Therapy Designation and Priority Review status, with a Prescription Drug User Fee Act (PDUFA) goal date set for June 23, 2025
- In January 2025, Innovent Biologics, Inc. and Jiangsu Aosaikang Pharmaceutical Co. Ltd. announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib. This drug is intended for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). Limertinib marks the 14th product in Innovent's commercial portfolio, further strengthening its tyrosine kinase inhibitor (TKI) franchise and offering a cutting-edge precision therapy for lung cancer patients
- In December 2024, BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults with tumors expressing PD-L1 (≥1)
- In November 2024, Daiichi Sankyo and AstraZeneca submitted a new Biologics License Application (BLA) for accelerated approval in the U.S. for datopotamab deruxtecan (Dato-DXd). The submission is for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have previously received systemic therapies, including an EGFR-targeted treatment
- In September 2024, Takeda announced that it had received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor targeting vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3. The drug is approved for the treatment of advanced or recurrent colorectal cancer (CRC) that is not curable or resectable and has progressed following chemotherapy
