KEYTRUDA® is indicated with conditions for:
- Adult patients with locally advanced unresectable or metastatic urothelial carcinoma, as monotherapy, who are not eligible for any platinum-containing chemotherapy.
- Adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.
KEYTRUDA® has been issued conditional marketing authorization pending the results of studies to verify its clinical benefit. Patients should be advised of this conditional marketing authorization.
For further information for Keytruda, please refer to Health Canada’s Notice of Compliance with conditions – drug products website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html.
And is indicated without conditions for:
- Treatment of adult patients with locally advanced or metastatic urothelial carcinoma, as monotherapy, who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinum-containing chemotherapy.
As of the December 2022 PM update, patients with locally advanced unresectable or metastatic UC no longer require PD-L1 biomarker testing prior to receiving KEYTRUDA®.
Canadian Urological Association/Genitourinary Medical Oncologists of Canada consensus statement2*
Second-line systemic therapy for unresectable, locally advanced and metastatic urothelial carcinoma:
In patients who have progressive disease during or after platinum-based chemotherapy, pembrolizumab is the preferred regimen (if available).
* Please refer to the CUA/GUMOC consensus statement for complete recommendations.
References
- Merck Canada Inc. KEYTRUDA® Product Monograph. December 29, 2022.
- Warren Canadian Urological Association (CUA)/Genitourinary Medical Oncologists of Canada (GMOC) consensus statement: Management of unresectable locally advanced and metastatic urothelial carcinoma. April 2019