The US Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb’s supplemental biologics license application (sBLA) for Yervoy for the adjuvant treatment of patients with Stage 3 melanoma who are at high risk of recurrence following complete surgical resection. The projected FDA action date is October 28, 2015.

Yervoy, which is a recombinant, human monoclonal antibody, was approved by the FDA for as a monotherapy for patients with unresectable or metastatic melanoma and is now approved in 40 countries. It posted 2014 sales of $1.3 billion. 

Yervoy blocks the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of Yervoy's effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses.

Bristol-Myers Squibb has a broad, ongoing development program in place for Yervoy spanning multiple tumor types. This includes Phase III trials in prostate and lung cancers.

Source: Bristol-Myers Squibb