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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 Notification to Implement Issued
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 February 15, 2018
Initial Recommendation Issued March 2, 2018
Feedback Deadline ‡ March 16, 2018
pERC Reconsideration Meeting April 19, 2018
Final Recommendation Issued May 3, 2018
Notification to Implement Issued May 18, 2018

‡ 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.