The US Food and Drug Administration (FDA) has issued a complete response letter for Bristol-Myers Squibb’s (BMS’s) supplemental biologics licence application (sBLA) for Opdivo (nivolumab) as a single agent to treat previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.
In the letter, the FDA requested the company to provide additional data in the BRAF mutated patient population.
The company said it is working to evaluate the request outlined by the FDA and will continue to work closely with the agency to determine whether additional data, currently under review, adequately addresses these comments.
The sBLA was based on clinical data from the Phase III CheckMate-066 trial, which evaluated Opdivo in treatment-naïve patients with BRAF wild-type advanced melanoma compared to dacarbazine.
Earlier this month, the FDA approved Opdivo as a single agent to treat patients with BRAF wild-type unresectable or metastatic melanoma, based on CheckMate-066.
As well as the CheckMate-066 data, the company submitted data for Opdivo in BRAF V600 mutation positive metastatic melanoma, which was the subject of the letter.
In September, the FDA accepted to review a separate sBLA, which included data from CheckMate-067 evaluating Opdivo as a single agent and in combination with Yervoy (ipilimumab) in patients with previously untreated advanced melanoma.
The FDA granted priority review with a target action date of 23 January 2016.
The company noted that data for Opdivo monotherapy in both BRAF wild-type and BRAF V600 mutation positive advanced melanoma was included as part of this application.
Over the last 20 years, surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment and in order to address this unmet medical need, the company is carrying out research in the field of cancer research and treatment known as immuno-oncology.
BMS is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different pathways in the treatment of cancer.
Image: A melanoma of approximately 2.5cm by 1.5cm. Photo: courtesy of Doc James.