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Polatuzumab Vedotin (Polivy) for DLBCL - Details

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Initial Recommendation Issued: April 1, 2021

Feedback Deadline: April 16, 2021

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Project Number PC0227-000
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 Open for Feedback on Recommendation
Pre Noc Submission No
NOC Date July 9, 2020
Manufacturer Hoffmann-La Roche Limited
Sponsor Hoffmann-La Roche Limited
Submission Date September 29, 2020
Submission Deemed Complete October 16, 2020
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ October 14, 2020
Check-point meeting December 3, 2020
pERC Meeting March 18, 2021
Initial Recommendation Issued April 1, 2021
Feedback Deadline ‡ April 16, 2021
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued
Therapeutic Area Diffuse large B-cell lymphoma (DLBCL)

‡ 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.