Zenocutuzumab

The FDA extended the review period for Merus N.V.'s biologics license application for zenocutuzumab in NRG1 fusion–positive cancer to February 4, 2025, to review submitted Chemistry, Manufacturing, and Controls information without requesting additional clinical data.

The FDA extended the PDUFA target action date for the BLA of zenocutuzumab (MCLA-128) for NRG1-positive NSCLC and pancreatic cancer to February 4, 2025, due to additional CMC review. The BLA is supported by the eNRGy trial data showing ORR of 37.2% in NSCLC and 42.4% in PDAC, with no treatment-related TEAEs leading to discontinuation.

The FDA extended the PDUFA goal date for Merus's zenocutuzumab BLA to Feb 4, 2025, to review recent CMC information. No additional clinical data was requested. Merus emphasizes the importance of a commercialization partnership for NRG1+ cancer patients.

FDA to decide on Journey's rosacea drug DFD-29, Merus' bispecific antibody for NSCLC and PDAC, PTC's gene therapy Upstaza for AADC deficiency, and Autolus' CAR T therapy obe-cel for ALL by November 4, 6, 13, and 16 respectively.

October saw FDA approvals for Pfizer's Hympavzi, Astellas' Vyloy, and Iterum's Orlynvah. November awaits decisions on Journey Medical's DFD-29, Merus' Zenocutuzumab, Astellas' IZERVAY, PTC Therapeutics' Upstaza, Autolus' Obe-cel, Applied Therapeutics' Govorestat, BridgeBio's Acoramidis, and Jazz Pharmaceuticals' Zanidatamab.

Oncology dominates pharmaceutical innovation, with 1,600 cancer drugs in development. Spending on cancer drugs is projected to reach $409 billion by 2028, with high costs for novel agents. Biosimilars and generics may provide savings but cannot match rising expenditures. The focus is shifting towards cell therapies for solid tumors, with 44% of trials initiated in 2023 targeting solid tumor indications. Several cancer drugs have been approved by the FDA this year, and many more are expected to receive approval decisions soon.

Bio-pharma advances in endocrinology, dermatology, cardiovascular, oncology, rare diseases, pulmonology, gastroenterology, and neurology highlight promising therapies like Eli Lilly’s orforglipron, Amgen’s MariTide, Novo Nordisk’s oral semaglutide, Johnson & Johnson’s JNJ-2113, Sanofi’s amlitelimab, Ionis’s olezarsen, BridgeBio’s acoramidis, NewAmsterdam Pharma’s obicetrapib, Jazz Pharmaceuticals’ zanidatamab, Syndax’s revumenib, Merus’ zenocutuzumab, Johnson & Johnson’s nipocalimab, Novo Nordisk’s Mim8, Solid Biosciences’ SGT-003, Merck’s sotatercept, Johnson & Johnson’s Tremfya, and Crossject’s Zepizure, with analyses including clinical data, revenue forecasts, and expected launch dates.