In rare setback, Bristol-Myers' Opdivo denied expanded melanoma label
- Just days after Bristol-Myers Squibb (BMS) received approval for Opdivo (nivolumab) of advanced kidney cancer, the FDA declined to approve the cancer immunotherapy for treatment of mutation positive metastatic melanoma.
- The agency's complete response letter (CRL) asked for more data on the effect of Opdivo in patients with BRAF V600 wild-type melanoma.
- Since Opdivo was first approved for treatment of advanced melanoma in December 2014, it has received several additional indications.
Since December 2014, Opdivo has been approved for treatment of advanced melanoma; non-small cell lung cancer (NSCLC); BRAF V600 wild-type melanoma (in combination with ipilimumab); metastatic NSCLC; BRAF V600 wild type melanoma; and second-line treatment of advanced kidney cancer.
In fact, Opdivo has emerged as a prototypical success story in oncology, an area where each advance generates a great deal of excitement and hope. BMS has been able to consistently demonstrate strong objective response rates (ORR), progression-free survival (PFS) and overall survival (OS) rates.
However, in the case of the treatment of patients with mutation positive metastatic melanoma, the FDA issued a CRL requesting more data. BMS stated it would continue to work with the FDA to provide adequate data. The pharma company is still on track to potentially receive an approval for the latest indication based on the original PDUFA date of January 23, 2016.