Zolbetuximab

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.

John L. Marshall, MD, highlights that understanding gastric cancer as multiple disease states will improve outcomes. He emphasizes the need for Claudin 18.2 testing in gastric cancer patients, alongside HER2 and MSI testing, to adapt to rapid developments in GI cancer treatment.

FDA accepts NDA resubmission for rivoceranib/camrelizumab combo in unresectable HCC; acalabrutinib plus venetoclax/rituximab yields 100% ORR in treatment-naive mantle cell lymphoma; FDA approves companion diagnostic for zolbetuximab in CLDN18.2+ gastric/GEJ cancer; first-in-class bicycle toxin conjugate targeting nectin-4 generates excitement in urothelial carcinoma; pembrolizumab earns EU approval in 2 new indications for endometrial and cervical cancer.

FDA approves Vyloy, a zolbetuximab drug targeting CLDN18.2 protein in HER2-negative gastric/GEJ adenocarcinoma, used with chemotherapy. Clinical trials show improved survival and progression-free periods. Common side effects include nausea, vomiting, and diarrhea.

FDA approval of zolbetuximab-clzb (Vyloy) plus fluoropyrimidine- and platinum-based chemotherapy benefits patients with Claudin 18.2–positive gastric or gastroesophageal junction adenocarcinoma, supported by phase 3 SPOTLIGHT and GLOW trials showing improved progression-free survival.

Roche reports 6% Group sales growth at constant exchange rates, driven by high demand for medicines and diagnostics. Pharmaceuticals Division sales rose 7%, with strong growth in base business, led by Vabysmo, Phesgo, and Ocrevus. Diagnostics Division sales increased 5%, with base business growing 8%. Key developments include US and EU approvals for new treatments, positive phase III data, and acquisitions to strengthen pipelines. Outlook for 2024 is confirmed.

The FDA approved the Ventana® CLDN18 (43-14A) RxDx Assay for determining Claudin 18.2 protein expression in gastric or gastroesophageal junction adenocarcinoma patients eligible for zolbetuximab-clzb treatment. Zolbetuximab, approved in combination with chemotherapy for CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma, was supported by phase 3 SPOTLIGHT and GLOW trials, which showed improved progression-free and overall survival.