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.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
