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FDA Approves Keytruda for Advanced Gastric Ca

Merck news release; 2017 Sep 22

The FDA has granted accelerated approval to Keytruda (pembrolizumab) for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Indications: Keytruda is a programmed death receptor-1-blocking antibody indicated in for the treatment of patients with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.

Dosage and administration: 200 mg every 3 weeks.

Efficacy and safety: Approval is based on results from a trial showing Keytruda produced an objective response rate of 13%.

Side effects/risks: The most common adverse reactions are fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, and constipation.

Citation:

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer [news release]. Silver Spring, MD: FDA. September 22, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm577093.htm. Accessed October 1, 2017.

Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co., Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s024lbl.pdf. Accessed October 1, 2017.

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