Zolbetuximab

Claudin18.2 targeted therapy market sees Vyloy (zolbetuximab) approval in 2024, with over 60 drugs in clinical trials, focusing on gastric cancer and expanding to other tumors. China emerges as a key innovator, with Innovent, MabWorks, and Biotheus leading progress.

Claudin18.2-targeting therapy market growth driven by encouraging results and expanding pipeline, with G/GEJ malignancies primary focus. Global market includes Western and Asian enterprises fostering innovation. Vyloy (zolbetuximab) first approved therapy, with strong sales and global expansion. Numerous other therapies in development, highlighting Claudin18.2's therapeutic potential. Companion diagnostics crucial for treatment precision.

Vyloy, the first Claudin 18.2-targeted gastric cancer drug, was approved in Korea, but its complex reimbursement system may limit patient access. The Korean Cancer Association plans to address policy issues, as the approval of Roche Diagnostics' companion diagnostic device for Claudin 18.2 is under review by HIRA, potentially delaying the drug's use.

Trump's campaign focused on expanding consumer and patient choice, including the 'Right to Try' law for terminally ill patients. Key ally RFK Jr. advocates for more FDA rules despite evidence of their ineffectiveness. The FDA's rejection of drugs like omburtamab and zolbetuximab, despite their potential benefits, highlights a need for reform. The FDA's approval process lags behind international standards, even with priority review. Accelerated approval programs have shown success, suggesting the need for their expansion and critical review of rejections.

The FDA's approval of zolbetuximab-clzb in combination with chemotherapy for HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction adenocarcinoma marks a significant shift towards precision medicine in treating this cancer. The approval, supported by the SPOTLIGHT and GLOW trials, highlights the potential of targeting CLDN 18.2 to improve patient outcomes, encouraging further research and timely biomarker testing.

FDA approved zolbetuximab-clzb (Vylov) plus chemotherapy for first-line treatment of HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma, based on SPOTLIGHT and GLOW trials. Dr. Jaffer A. Ajani discussed clinical use considerations, including adverse effects and CLDN18.2 as a biomarker.

The FDA's cautious approach delays life-saving drugs like CAM2029 for acromegaly and zolbetuximab for gastric cancer due to manufacturing concerns, despite international approvals. The FDA should adopt a more flexible approach, focusing on targeted recalls rather than complete drug rejections.