FDA News

FDA grants priority review to Keytruda for microsatellite instability–high cancers

The FDA granted priority review to the anti–PD-1 therapy pembrolizumab for use in previously treated patients with advanced microsatellite instability–high cancers, according to the agent’s manufacturer.

The supplemental biologics license application seeks approval of pembrolizumab (Keytruda, Merck) at a fixed dose of 200 mg every 3 weeks. The application includes data from five uncontrolled, open-label, multicohort, multisite phase 1 and phase 2 trials designed to evaluate the agent’s activity in patients with microsatellite instability–high cancers.

Roger M. Perlmutter, MD, PhD
Roger M. Perlmutter

The FDA set a target action date of March 8.

Microsatellites are short repetitive sequences of DNA found throughout the genome, according to a Merck-issued press release. A deficiency in the cell’s ability to repair errors in the DNA sequence that occur during cell division leads to changes in microsatellite repeats, causing what is known as microsatellite instability.

“The FDA’s acceptance of this application represents an important advance for the field of immuno-oncology,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a company-issued press release. “We believe that patients whose tumors harbor DNA repair defects may be especially responsive to [pembrolizumab], and we look forward to working with the FDA to bring this important new therapy to these very challenging treatment situations.”

Pembrolizumab previously received breakthrough therapy designation for treatment of unresectable or metastatic microsatellite instability–high non-colorectal cancer, as well as for treatment of patients with unresectable or metastatic microsatellite instability–high colorectal cancer.

Pembrolizumab already is approved for the treatment of patients with unresectable or metastatic melanoma, certain patients with metastatic non–small cell lung cancer, and patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-containing chemotherapy.

The FDA granted priority review to the anti–PD-1 therapy pembrolizumab for use in previously treated patients with advanced microsatellite instability–high cancers, according to the agent’s manufacturer.

The supplemental biologics license application seeks approval of pembrolizumab (Keytruda, Merck) at a fixed dose of 200 mg every 3 weeks. The application includes data from five uncontrolled, open-label, multicohort, multisite phase 1 and phase 2 trials designed to evaluate the agent’s activity in patients with microsatellite instability–high cancers.

Roger M. Perlmutter, MD, PhD
Roger M. Perlmutter

The FDA set a target action date of March 8.

Microsatellites are short repetitive sequences of DNA found throughout the genome, according to a Merck-issued press release. A deficiency in the cell’s ability to repair errors in the DNA sequence that occur during cell division leads to changes in microsatellite repeats, causing what is known as microsatellite instability.

“The FDA’s acceptance of this application represents an important advance for the field of immuno-oncology,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a company-issued press release. “We believe that patients whose tumors harbor DNA repair defects may be especially responsive to [pembrolizumab], and we look forward to working with the FDA to bring this important new therapy to these very challenging treatment situations.”

Pembrolizumab previously received breakthrough therapy designation for treatment of unresectable or metastatic microsatellite instability–high non-colorectal cancer, as well as for treatment of patients with unresectable or metastatic microsatellite instability–high colorectal cancer.

Pembrolizumab already is approved for the treatment of patients with unresectable or metastatic melanoma, certain patients with metastatic non–small cell lung cancer, and patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-containing chemotherapy.

    See more from Immuno-Oncology Resource Center