Muscle-invasive bladder cancer neoadjuvant treatment with immunotherapy combination and oncology research
RegulatoryBusiness Wire

Merck Receives FDA Approval for Keytruda in Neoadjuvant Bladder Cancer

Merck announces FDA approval of Keytruda (pembrolizumab) plus chemotherapy as neoadjuvant treatment for muscle-invasive bladder cancer prior to radical cystectomy.

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment for adults with muscle-invasive bladder cancer (MIBC) prior to radical cystectomy. In the Phase 3 KEYNOTE-866 trial, KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in pathological complete response rate compared to chemotherapy alone. The pCR rate was 44.4% for KEYTRUDA plus chemotherapy versus 30.1% for chemotherapy alone. This approval provides patients with MIBC a new neoadjuvant treatment option to improve surgical outcomes.

Original Source

Business Wire
Share:

Previous

Pfizer Receives Full FDA Approval for Lorbrena as First-Line ALK-Positive Lung Cancer Treatment

Next

Vertex Pharmaceuticals Reports Phase 3 Results for Journavx in Diabetic Peripheral Neuropathic Pain