OREANDA-NEWS. June 02, 2015. Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab)+Yervoy (ipilimumab) regimen in patients with previously untreated advanced melanoma. The FDA also granted Priority Review for this application. The projected FDA action date is September 30, 2015. This is the first regulatory milestone for an Immuno-Oncology regimen in cancer.

This new sBLA accepted by the FDA includes data from CheckMate -069, the first randomized trial evaluating the Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma. In the trial, patients with BRAF wild-type mutation status treated with the regimen experienced improved objective response rate as compared to patients administered Yervoy monotherapy. The Opdivo+Yervoy regimen achieved an objective response rate of 61%, including a 22% complete response rate, in previously untreated advanced melanoma patients. The safety profile also was consistent with previously-reported studies evaluating the Opdivo+Yervoy regimen.

“Our strategy has always been to bring forth combination regimens of our Immuno-Oncology medicines to help bring the potential of long-term survival to patients,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “The Opdivo+Yervoy regimen, in the CheckMate -069 trial, demonstrated greater efficacy beyond standard of care for patients with advanced melanoma.”

About Opdivo and Yervoy

Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo and Yervoy are both monoclonal antibodies and immune checkpoint inhibitors that target separate, distinct checkpoint pathways. Inhibition of these immune checkpoint pathways results in enhanced T cell function greater than the effects of either antibody alone.

Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. In the U.S., the FDA granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries.

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials- as monotherapy or in combination with other therapies- in which more than 8,000 patients have been enrolled worldwide.

Immuno-Oncology at Bristol-Myers Squibb

Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.

To address this unmet medical need, Bristol-Myers Squibb is leading research in an innovative field of cancer research and treatment known as Immuno-Oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company 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.

Bristol-Myers Squibb is committed to advancing the science of Immuno-Oncology, with the goal of changing survival expectations and the way patients live with cancer.