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Polatuzumab Vedotin (Polivy) for DLBCL - Details

Project Number pCODR 10227
Brand Name Polivy
Generic Name Polatuzumab Vedotin
Tumour Type Lymphoma
Indication Diffuse Large B-Cell Lymphoma (DLBCL)
Funding Request Polatuzumab vedotin, in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy.
Review Status Under Review
Pre Noc Submission No
NOC Date
Manufacturer Hoffmann-La Roche Limited
Sponsor Hoffmann-La Roche Limited
Submission Date September 29, 2020
Submission Deemed Complete October 16, 2020
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ October 14, 2020
Check-point meeting (target date) December 3, 2020
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
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.