MSD to withdraw US accelerated approval indication for pembrolizumab for third or further-line treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junctionadenocarcinoma whose tumours express PD-L1
The voluntary decision was made in consultation with the FDA, after pembrolizumab failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a Phase III trial in this setting.
Source:
Biospace Inc.