Zolbetuximab

Zolbetuximab, a CLDN18.2-targeted IgG1 monoclonal antibody, combined with frontline chemotherapy, extended PFS and OS in HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma patients positive for CLDN18.2, according to phase 3 SPOTLIGHT and GLOW trials. The FDA approved zolbetuximab in October 2024 for first-line treatment of these patients. Median PFS was 9.2 months with zolbetuximab vs 8.2 months with placebo, and median OS was 16.4 months vs 13.7 months, respectively. Zolbetuximab was also approved in Japan and Europe in 2024.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.

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.