The FDA has approved a revised label for Merck’s immunotherapy drug Keytruda, limiting its use in some gastrointestinal cancer treatments to patients whose tumors express a minimum level of PD-L1 protein.
The updated prescribing information now restricts first-line use of Keytruda in combination with chemotherapy for HER-2 negative gastric or gastroesophageal junction adenocarcinoma to adults whose tumors express PD-L1 with a combined positive score of 1 or higher, according to a letter issued to the drugmaker in late May.
The FDA stated the changes reflect a “favorable risk-benefit assessment” for specific populations based on updated data. The agency also reminded Merck of a postmarketing commitment to complete validation of a PD-L1 diagnostic test, with a final report expected by December.
