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Opdivo for classical Hodgkin Lymphoma (after failure of ASCT) – Details

Project Number pCODR 10120
Brand Name Opdivo
Generic Name Nivolumab
Strength 10 mg/mL
Tumour Type Lymphoma
Indication classical Hodgkin Lymphoma after failure of ASCT
Funding Request For the treatment of adult patients with classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after autologous stem cell transplantation (ASCT) and brentuximab vedotin, or 3 or more lines of systemic therapy including ASCT
Review Status Under Review
Pre Noc Submission Yes
NOC Date November 10, 2017
Manufacturer Bristol-Myers Squibb
Submitter Bristol-Myers Squibb
Submission Date September 29, 2017
Submission Deemed Complete October 6, 2017
Submission Type New Indication
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ October 16, 2017
Check-point meeting November 20, 2017
pERC Meeting (target date) February 15, 2018
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.