Bristol-Myers Squibb Plans BLA For Opdivo In Advanced Melanoma

Bristol-Myers Squibb reported that it is planning to file a Biologics License Application (BLA) in the third quarter of 2014 for Opdivo (nivolumab) for the treatment of previously treated advanced melanoma.

Opdivo is an investigational, fully-human PD-1 (programmed death-1) immune checkpoint inhibitor that aims to trigger the immune system response to cancer cells by binding to the checkpoint receptor PD-1 expressed on activated T-cells. Cancer cells may survive and spread by exploiting checkpoint pathways to slip past the immune system’s radar. The company said it is investigating whether blocking the PD-1 pathway will help the immune system to identify and kill cancer cells.

The company announced its intentions for a third quarter BLA filing after a round of discussions with the U.S. Food and Drug Administration (FDA). Michael Giordano, Head of Oncology Development at BMS, said, “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer.”

Last year the FDA designated Fast Track status to Opdivo in melanoma, non-small-cell lung cancer, and renal cell carcinoma. The drug also received Breakthrough Therapy status earlier this year for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and treatment with brentuximab.

Melanoma is a skin cancer characterized by excessive growth of melanocytes that produce pigment in the skin. When metastatic, melanoma can spread beyond the surface of the skin to other parts of the body such as the lymph nodes, brain, or lungs. Approximately 232,130 cases of melanoma were diagnosed in 2012. The disease’s prevalence has been noted to be rising in the last 30 years.

The planned BLA submission in advanced melanoma is supported by results from the Phase III trial Checkmate-037. The multi-center, randomized, multi-national, open label trial compared Opdivo to dacarbazine (DTIC) or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have undergone Yervoy (ipilimumab) treatment and a BRAF inhibitor regimen if BRAF-mutation positive.

The company said it has proposed the brand name Opdivo for nivolumab once it receives approval from regulatory officials.