FDA Accepts 2 sBLAs for Pembrolizumab for Bladder Cancer

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The FDA granted priority review to 2 supplemental Biologics License Applications for pembrolizumab (Keytruda) for locally advanced or metastatic urothelial carcinoma.
The FDA granted priority review to 2 supplemental Biologics License Applications for pembrolizumab (Keytruda) for locally advanced or metastatic urothelial carcinoma.

The U.S. Food and Drug Administration (FDA) has granted priority review to 2 supplemental Biologics License Applications (sBLAs) for pembrolizumab (Keytruda) for locally advanced or metastatic urothelial carcinoma.1

One application is for the first-line use of pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. The second is for the second-line use of the PD-1 inhibitor among patients with locally advanced or metastatic urothelial carcinoma who had disease progression on or after platinum-containing chemotherapy. The FDA is expected to take action on both sBLAs by June 14, 2017.

The first sBLA is based on data from the open-label, phase 2 KEYNOTE-052 trial (ClinicalTrials.gov Identifier: NCT02335424), which were presented at the European Society for Medical Oncology (ESMO) 2016 Congress.

The study showed that 24% of the 100 treatment-naïve patients with advanced urothelial cancer achieved an objective response, including 11 patients with a PD-L1 expression of 10% or greater.

The second application is based on findings from the phase 3 KEYNOTE-045 study (ClinicalTrials.gov Identifier: NCT02256436), which were presented at the European Cancer Congress (ECCO) 2017.

Treatment with pembrolizumab reduced the risk of death by nearly 28% compared with investigator's choice of chemotherapy (hazard ratio, 0.723; 95% CI, 0.59-0.91; P < .0022) among 270 patients with recurrent or progressive metastatic urothelial carcinoma who had failed platinum-based chemotherapy.

RELATED: Priority Review Granted to Atezolizumab for Bladder Cancer Subtype

If approved, pembrolizumab would be the third immune checkpoint inhibitor indicated for the treatment of patients with urothelial carcinoma.

Reference

  1. FDA accepts two sBLAs for Merck's Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings. Merck website. http://www.mercknewsroom.com/news-release/oncology-newsroom/fda-accepts-two-sblas-mercks-keytruda-pembrolizumab-locally-advanced-. Published February 3, 2017. Accessed February 6, 2017.

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