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Pembrolizumab (Keytruda) classical Hodgkin Lymphoma – Details

Project Number pCODR 10109
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 50 mg/vial
Tumour Type Lymphoma
Indication classical Hodgkin Lymphoma (cHL)
Funding Request As monotherapy is indicated for the treatment of adult patients with refractory or relapsed classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV) or who are not ASCT candidates and have failed BV
Review Status Under Review
Pre Noc Submission Yes
NOC Date
NOC/c Date September 8, 2017
Manufacturer Merck Canada Inc.
Submitter Merck Canada Inc.
Submission Date July 7, 2017
Submission Deemed Complete July 14, 2017
Submission Type New Indication
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ July 21, 2017
Check-point meeting September 6, 2017
pERC Meeting October 19, 2017
Initial Recommendation Issued November 2, 2017
Feedback Deadline ‡ November 16, 2017
pERC Reconsideration Meeting (target date) December 14, 2017
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.