In patients with previously untreated, metastatic, non-squamous non-small cell lung cancer (NSCLC), pembrolizumab plus pemetrexed-platinum has proven to be an effective treatment compared with pemetrexed-platinum alone in increasing the proportion of patients who experience a complete or partial response, as shown in the KEYNOTE-189 study. Based on the results of this study, the FDA recently approved a new indication for pemetrexed in this combination for the first-line treatment ...

The FDA recently approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus Calmette-Guérin (BCG) therapy. The approval was based on Keynote 057 (NCT02625961), a phase 2 trial in which pembrolizumab produced a complete response rate of 41% in patients with this disease. In this interview with i3 Health, Ashish Kamat, MD, MBBS, Professor of Urologic Oncology (Surgery) and Cancer Research at MD Anderson...

The FDA has approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with high-risk non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary tumors. Pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, is indicated for patients who are ineligible for or have elected not to receive radical cystectomy and who do not respond to bacillus Calmette-Guérin (BCG) therapy.The approval was based on Keynote 057 (NCT02625961), a multicenter, single...

On July 30, 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus (ESCC) whose tumors expressed a programmed death-ligand 1 (PD-L1) combined positive score (CPS) of at least 10 and whose disease progressed after at least one line of systemic therapy. The approval was based on two clinical trials. One of these was Keynote-181, which enrolled 628 patients with locally advanced or metastatic ESCC w...

Pembrolizumab (Keytruda®, Merck) has been approved by the FDA for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus (ESCC) with tumors expressing a programmed death ligand-1 (PD-L1) combined positive score (CPS) of at least 10 and with disease progression following one or more previous systemic treatments.The approval was based on the Keynote-181 (NCT02559687) and Keynote-180 (NCT02564263) clinical trials. Keynote-181 enrolled 628 patients with recur...