With Japan ok, Astellas’ Vyloy becomes first-ever approved CLDN18.2 antibody

2024-03-27

优先审批临床3期上市批准临床结果申请上市

Although a US rejection earlier this year tempered some of the enthusiasm surrounding Astellas’ CLDN18.2-targeting antibody, Tuesday’s approval in Japan for gastric cancer may help to course-correct the treatment’s trajectory.

The Ministry of Health, Labour and Welfare (MHLW) cleared Vyloy (zolbetuximab) to treat patients with CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer.

The approval was driven by data from the Phase III SPOTLIGHT and GLOW studies, which evaluated Vyloy plus chemotherapy as first-line treatment for patients with CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, versus chemotherapy alone. Both trials met the primary endpoint of progression-free survival as well as the key secondary endpoint of overall survival.

Last year, a FirstWord poll of oncologists showed a bullish opinion on the monoclonal antibody (mAb), with the majority of participants projecting for Vyloy to quickly become a new standard of care in this population of gastric cancer patients. For more, see KOL Views Q&A: Leading oncologist excited to get to work learning how to use zolbetuximab in gastric cancer.

However, in January, the FDA declined to approve the mAb following a priority review, citing third-party manufacturing deficiencies.

While Astellas hasn’t provided an update since receiving the complete response letter, it’s possible the Japanese pharma will be able to quickly resolve the agency’s manufacturing concerns, especially since no issues regarding efficacy or safety data were raised.

The antibody is also under review in China and the EU.

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