NEW YORK – The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) on Wednesday approved Astellas Pharma's Vyloy (zolbetuximab) in patients with advanced claudin (CLDN) 18.2-positive, HER2-negative gastric or gastroesophageal junction cancer.
UK regulators based their approval on the results of two Phase III clinical trials, SPOTLIGHT and GLOW. In SPOTLIGHT, Astellas pitted frontline Vyloy plus mFOLFOX6 chemotherapy against placebo plus mFOLFOX6. The GLOW study design was similar but with CAPOX chemotherapy instead of mFOLFOX6. Both studies enrolled patients with advanced, CLDN18.2-positive, HER2-negative unresectable gastric or gastroesophageal cancer.
In SPOTLIGHT, 38.8 percent of patients treated with Vyloy plus chemo were still alive after two years, whereas the same was true for 28.4 percent of patients who'd received placebo plus chemo. In GLOW, the two-year overall survival rates were 28.9 percent and 17.4 percent for patients treated with the Vyloy-chemo combination and the placebo-chemo combination, respectively.
Once MHRA has licensed a drug, the National Institute for Health & Care Excellence (NICE) reviews the drug to assess whether it is cost-effective enough to provide the treatment to patients within England's National Health Service, and a similar analysis takes place for patients in Wales, Scotland, and Northern Ireland.
The MHRA approval comes several months after Astellas announced it had resubmitted a US biologics license application for Vyloy in CLDN18.2-positive gastric and gastroesophageal junction cancer patients. The BLA resubmission came after the US Food and Drug Administration issued a complete response letter to Astellas saying it would not approve the therapy due to deficiencies at the third-party manufacturing site that makes the drug. Astellas maintained that the FDA had no issue with any of the application's clinical data. Now that the firm has refiled for approval in the US, the FDA is expected to reach a decision by Nov. 9, 2024.
Astellas is also seeking Vyloy approval in Europe, China, and Japan.