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Pomalyst in combo with dexamethasone and bortezomib for Multiple Myeloma (second-line or beyond) – Details

Project Number pCODR 10165
Brand Name Pomalyst
Generic Name Pomalidomide
Strength 1 mg, 2 mg, 3 mg & 4 mg
Tumour Type Myeloma
Indication Multiple Myeloma (second-line or beyond)
Funding Request Pomalidomide in combination with dexamethasone and bortezomib for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide
Review Status Under Review
Pre Noc Submission Yes
NOC Date July 2, 2019
Manufacturer Celgene Inc.
Sponsor Celgene Inc.
Submission Date March 15, 2019
Submission Deemed Complete March 29, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ March 29, 2019
Check-point meeting June 5, 2019
pERC Meeting August 15, 2019
Initial Recommendation Issued (target date) August 29, 2019
Feedback Deadline (target date) ‡ September 13, 2019
pERC Reconsideration Meeting (target date)
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.