Health Canada Approves KEYTRUDA Combo for Muscle-Invasive Bladder Cancer

Merck's KEYTRUDA has been approved by Health Canada for treating adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin-based chemotherapy. The approval is based on results from the Phase 3 KEYNOTE-905 trial, which showed a statistically significant improvement in EFS and OS in patients treated with neoadjuvant and adjuvant KEYTRUDA in combination with enfortumab vedotin compared to surgery alone.

The study demonstrated a statistically significant difference in pCR rate. Michelle Colero, Executive Director at Bladder Cancer Canada, said 'Muscle-invasive bladder cancer can have a significant impact on patients and their families... The availability of an additional treatment option for eligible patients is welcome news for the bladder cancer community.'

Bladder cancer is the fifth most commonly diagnosed cancer in Canada, with around one-quarter (25%) of cases involving muscle-invasive disease. For those ineligible for cisplatin-based chemotherapy, radical cystectomy alone has traditionally been the standard treatment approach.