Merck (MRK) said Wednesday that Keytruda, in combination with enfortumab vedotin, has received Canadian approval for the treatment of muscle-invasive bladder cancer in adults who are ineligible for cisplatin-containing chemotherapy.

The company said that the approval from Health Canada was based on results from a phase-3 trial, which was conducted in collaboration with Pfizer (PFE) and Astellas.

Results from the trial showed that patients treated with neoadjuvant and adjuvant Keytruda in combination with enfortumab vedotin had statistically significant improvements in event-free survival and overall survival compared with radical cystectomy and pelvic lymph node dissection alone, the company said.

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