Zanidatamab

The FDA approved zanidatamab-hrii (Ziihera) for previously treated, unresectable, or metastatic HER2-positive biliary tract cancer, based on the phase 2b HERIZON-BTC-01 trial. The trial showed an objective response rate of 41.3% and median progression-free survival of 5.5 months.

Zymeworks Inc. initiates a Phase 1 trial to assess ZW191's safety and tolerability in treating advanced FRα-expressing solid tumors, including ovarian, endometrial, and NSCLC cancers. The global study aims to enroll 145 patients across North America, Europe, and the Asia-Pacific region.

ALX Oncology's Phase 1b/2 trial results of evorpacept combined with zanidatamab in HER2-positive and HER2-low metastatic breast cancer accepted for poster spotlight at SABCS 2024, to be presented by Alberto J. Montero on Dec. 12.

ALX Oncology's Phase 1b/2 trial results of evorpacept combined with zanidatamab for HER2-positive and HER2-low metastatic breast cancer accepted for poster spotlight at SABCS, Dec 12.

Recent advancements in HCC and BTC treatment include targeted therapy combinations like atezolizumab plus bevacizumab for HCC and durvalumab with gemcitabine and cisplatin for BTC, improving survival outcomes. Liquid biopsies and precision medicine are also transforming early detection and treatment options.

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.

Zymeworks Inc. to report Q3 2024 financial results on Oct 31, 2024, followed by a conference call at 4:30 pm ET. Zanidatamab, a HER2-targeted bispecific antibody, is under evaluation in global clinical trials and has BLA submissions accepted by the FDA and NMPA for Priority Review.

FDA reviews DFD-29 for rosacea, eladocagene exuparvovec for AADC deficiency, inavolisib for PIK3CA-mutated HR-positive breast cancer, acoramidis for transthyretin amyloid cardiomyopathy, and zanidatamab for HER2-amplified biliary tract cancer, with PDUFA dates in November 2024.