BMS Gets EU nod for Cancer Drugs
Bristol-Myers Squibb (BMS) and AbbVie’s cancer treatment Empliciti has received the green light in Europe to treat multiple myeloma, a blood cancer that develops in the bone marrow. The drug has been approved in combination with lenalidomide and anti-inflammatory medicine dexamethasone for patients who have received at least one previous therapy, making it the only immunostimulatory antibody cleared for the disease in Europe.
The approval was given after data from a Phase 3 trial showed that the cancer progressed more slowly when taking the combined therapy compared with those taking lenalidomide and dexamethasone alone. Follow-up data also showed a 53% improvement in the progression free survival (PFS) rate at three years.
Multiple myeloma is difficult to treat and often incurable with less than half of patients surviving for five or more years after diagnosis. Estimates show that more than 80,000 people around the world die from the disease every year.
Meanwhile, BMS’s Opdivo has gained a fifth approval in Europe, this time in combination with Yervoy for treating advanced (unresectable or metastatic) melanoma in adults. This is the first and only approved combination of two immuno-oncology agents in Europe.
The decision was based on a Phase 3 study which showed an improved PFS and reduced disease progression for the combined therapy compared with Opdivo on its own. Melanoma, a form of skin cancer, is the ninth most common cancer in Europe with more than 20,000 deaths each year. Metastatic melanoma, where the cancer spreads beyond the skin surface to other organs, is the deadliest form of the disease.
