FDA tentatively approves AND Application for Lutetium Lu 177 Dotatate (PNT2003) for the treatment of somatostatin receptor-positive GEP-NETs March 3, 2026
FDA approves monthly RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) in 1L EGFR+ NSCLC February 25, 2026
European Commission grants conditional marketing authorization for ANKTIVA + BCG in BCG-unresponsive NMIBC CIS, with or without papillary tumors February 25, 2026
Calquence + venetoclax approved in the US as oral, fixed-duration combination for 1L CLL patients February 25, 2026
KEYTRUDA and KEYTRUDA QLEX, Plus Paclitaxel ± Bevacizumab, Approved for 2L/3L PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma February 17, 2026
US FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer February 17, 2026
FDA Approves Label Update for Yescarta for R/R Primary Central Nervous System Lymphoma February 9, 2026
FDA Approves Larger Vial Size for Nelarabine IV Administration for the Treatment of T-ALL and T-LBL February 1, 2026
DARZALEX FASPRO®-based quadruplet regimen approved in the US for 1L transplant-ineligible multiple myeloma patients February 1, 2026
NMPA approves TABOSUN + TYVYT combo for the neoadjuvant treatment of patients with stage IIB-III resectable MSI-H/dMMR colon cancer January 4, 2026
Japan’s MHLW approves Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with 2L+ FL December 30, 2025
US FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and LAZCLUZE® (lazertinib) combo for 1L EGFRm NSCLC December 22, 2025
ENHERTU Plus Pertuzumab Approved in the US for Patients with 1L HER2 Positive Metastatic Breast Cancer December 22, 2025
FDA approves AKEEGA® for BRCA2m metastatic CSPC with 54% reduction in disease progression vs SOC December 15, 2025
FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced CSCC December 9, 2025
FDA approves expanded indication for Jaypirca (pirtobrutinib) for adults with R/R CLL/SLL previously treated with a covalent BTK inhibitor December 9, 2025
European Commission (EC) grants approval to Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of adult patients with R/R, BTK inhibitor-treated MCL December 2, 2025
Imfinzi approved in the US as perioperative immunotherapy for patients with early gastric/GEJ cancers December 2, 2025
