FDA Approves KEYTRUDA® (pembrolizumab) Patients with Unresectable or Metastatic, Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient Cancer

KEYTRUDA Now Approved for Adult and Pediatric Patients with MSI-H or Mismatch Repair Deficient Solid Tumors That Have Progressed Following Prior Treatment and Who Have No Satisfactory Alternative Treatment Options, Which Includes MSI-H or Mismatch Repair Deficient Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan

Truckee, CA.—The U.S. Food and Drug Administration (FDA) has approved a new indication for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy.
KEYTRUDA is now indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. In children, the recommended dose of KEYTRUDA is 2 mg/kg (up to a maximum of 200 mg) administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression. Immune-mediated adverse reactions occurred with KEYTRUDA including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Based on the severity of the adverse reaction, KEYTRUDA (pembrolizumab) should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Monitor patients for signs and symptoms of infusion-related reactions; for Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Female patients of reproductive potential should be advised of the potential hazard to a fetus. For more information regarding immune-mediated adverse reactions.  

“The FDA’s approval of this new indication for KEYTRUDA further supports Merck’s commitment to helping people with difficult-to-treat cancers,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We are thankful to the researchers, as well as the patients and their families who helped make today’s approval possible.”

MAY 23, 2017
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