We have been following discussions with the FDA around approving Opdivo (nivolumab) as a first-line therapy for metastatic melanoma. Currently the label require patients whose tumors have the BRAF mutation to have BRAF therapy first, then Yervoy (ipilimumab), and only take "nivo" after those approaches have stopped working or proven intolerable. Patients without the BRAF mutation must progress on ipi before taking nivo.
The company who makes nivo, BMS, has applied to expand the approval so the drug can be given as the first treatment, instead of the second or third. The FDA said it would make a decision by September 30. They have now announced that the deadline for that decision has been pushed back by two months. What does this mean and how will it affect patients?
First, the reason for the delay is that BMS has recently submitted a large amount of new data focusing on patients with the BRAF mutation. The FDA simply needs time to review this data.
Second, based in the initial data the FDA could have approved nivo as first line therapy only for patients whose tumors do not have the BRAF mutation. With this additional data they are more likely to take action for all patients regardless of BRAF status.
Third, the oncology drug section of the FDA has done a good job recently of acting before their deadline, and sometimes well before the deadline, so we can hope this will be the case in this situation.
Fourth (and last!), many oncologist are prescribing either Opdivo or Keytruda (which has the same restrictions) as first line therapy despite what the label says. This is in keeping with other guidelines and has not generally faced any pushback from insurance companies around coverage.
The bottom line is that the delay is not a cause for alarm and may result in more patients having access to anti-PD1 therapy faster.
Tim–MRF
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