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The FDA has approved a new dosage form and treatment of Keytruda (pembrolizumab, Merck & Co), a programmed death receptor-1-blocking antibody already indicated for various cancers.
The new dosage form is 50 mg of lyophilized powder, shipped in a single-dose vial to be reconstituted and used as an injection solution.
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Regarding new treatment approval, the FDA has expanded Keytruda’s use to be used as a first-line treatment for patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.
Keytruda has also been approved as a first-line treatment for patients with advanced renal cell carcinoma, in conjunciton with axitinib (Inlyta, Pfizer).
Results from a randomized, multicenter, open-label trial in 861 patients indicate a statstically significant improvement in overall survival rate and progression-free survival. The most common adverse adverse recations recorded included: diarrhea, fatigue/asthenia, hypertension, hypothyroidism, decreased appetite, hepatotoxicity, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.
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