pembrolizumab (KEYTRUDA) | FDA - U.S. Food and Drug …
WEBOn August 5, 2016, the U. S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with...
FDA approves pembrolizumab with chemotherapy for …
WEBSep 17, 2024 · Full prescribing information for Keytruda will be posted on Drugs@FDA. Efficacy and Safety. Efficacy was investigated in KEYNOTE-483 (NCT02784171), a randomized, open-label trial in patients with ...
WEBKEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.20 . Triple-Negative Breast Cancer . KEYTRUDA is indicated for the treatment of patients with high -risk early-stage triple-negative breast
WEBKEYTRUDA is a programmed death receptor-1 (PD-1)-blocking . antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. (1.1) for the adjuvant treatment...
FDA approves pembrolizumab as adjuvant treatment for non …
WEBOn January 26, 2023, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a...
WEBKEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no...
KEYTRUDA® (pembrolizumab) - Official Site
WEBVisit www.fda.gov/medwatch or call 1-800-FDA-1088. Please read the accompanying Medication Guide for KEYTRUDA and discuss it with your doctor. The physician Prescribing Information also is available.
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Adult …
WEBMay 25, 2017 · KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of ... - Merck
WEBJul 27, 2021 · KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus …
WEBJun 17, 2024 · KEYTRUDA is now the first and only anti-PD-1 therapy FDA-approved in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Approval marks the third FDA-approved indication for KEYTRUDA in endometrial carcinoma and the 40 th indication for KEYTRUDA in the US