Zolbetuximab

FDA approvals in October 2024 include nivolumab for resectable NSCLC, inavolisib triplet for PIK3CA-mutated HR+/HER2– advanced breast cancer, Optune Lua for metastatic NSCLC, zolbetuximab plus chemotherapy for CLDN18.2+ gastric or GEJ adenocarcinoma, and asciminib for newly diagnosed Ph+ chronic-phase CML. Other approvals include Cologuard Plus for average-risk CRC and Ion Torrent Oncomine Dx Target Test for vorasidenib.

FDA approved several cancer therapies in October, including Opdivo for non-small cell lung cancer, Itovebi for advanced breast cancer, Vyloy for HER2-negative gastric or GEJ adenocarcinoma, Jylamvo for children with acute lymphoblastic leukemia, and Scemblix for newly diagnosed chronic myeloid leukemia.

Cindy Medina Pabon discusses the FDA approval of zolbetuximab-clzb (Vyloy) for HER2-negative, Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma. Zolbetuximab, combined with chemotherapy, was approved based on SPOTLIGHT and GLOW trials, showing survival benefits. This marks a significant advancement in targeted therapy for gastric cancer.

Experts at Annual Oncology Update 2024 discussed new cancer treatments, including Dr. Mario Bilusic's phase 3 prostate cancer data from the PEACE-3 study and Dr. Elisa Krill-Jackson's updates on HER2+ treatments for breast cancer patients with brain metastases.

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.

Astellas Pharma withdraws its marketing authorisation application for avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) from the European Medicines Agency (EMA) following discussions with the CHMP. ACP, an investigational synthetic aptamer, inhibits the complement C5 protein, which contributes to GA-related vision loss. Astellas remains confident in ACP's clinical profile and its potential to benefit GA patients, despite the withdrawal, and is committed to exploring all options to make ACP accessible globally.

FDA approves 420-mg trastuzumab-strf for HER2-overexpressing cancers, and zolbetuximab for CLDN18.2-positive gastric/GEJ adenocarcinoma. FDA delays decision on sotorasib plus panitumumab for KRAS G12C-mutated CRC to Jan 2025. LP-184 granted fast track designation for glioblastoma treatment.