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The U.S. Food and Drug Administration has granted Priority Review status to Keytruda (pembrolizumab) for the first-line treatment of patients with unresectable or metastatic melanoma. The drug is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

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The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA). The FDA action date for Keytruda for this indication is December 19.


KEYNOTE-006 Study

The submission for this new indication for Keytruda as first-line treatment will be based on data from the KEYNOTE-006 Phase III study, data from which were presented at the American Association for Cancer Research Annual Meeting earlier this year (OT 6/10/15 issue).


The trial evaluated 811 patients with unresectable or metastatic melanoma with progression of disease, and found that patients treated with Keytruda had longer progression-free survival than patients treated with CTLA-4-blocking antibodies.


Overall survival data was not yet available when those data were reported.


Prior Approvals & Actions

Keytruda was approved last year for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if the patient has a BRAF V600 mutation, a BRAF inhibitor (OT 10/10/14issue).


This previous approval was part of the FDA's accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. The drug's manufacturer, Merck, has now submitted additional data from the KEYNOTE-002 Phase II trial for this previously approved indication and the FDA has set its action date for December 24.


Keytruda also previously received Priority Review status for the treatment of patients with advanced non-small cell lung cancer whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present (OT 6/25/15 issue).