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FDA News Briefs for Monday, June 17, 2019

June 17, 2019

These Food and Drug Administration (FDA) developments came in last week:

 

FDA Expanded Approval: Keytruda

The FDA has granted approval of Keytruda (pembrolizumab; Merck Sharp & Dohme Corp.) as monotherapy for first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell cancer (HNSCC) whose tumors express PD-L1. The expanded approval also approved Keytruda in combination with chemotherapy as first-line therapy for metastatic or unresectable, recurrent HNSCC regardless of PD-L1 expression. More Information.

 

Safety Communication: Fecal Microbiota for Transplantation

The FDA has released a safety communication warning healthcare providers and patients about the potential risks associated with the investigational use of fecal microbiota for transplantation (FMT). The FDA reported that 2 immunocompromised adults developed invasive bacterial infections after receiving investigational FMT from the same donor; 1 of the adults died. FMT is currently not FDA approved for any indication. More Information.