The U.S. Food and Drug Administration (FDA) have raised the green light on Thursday, Oct. 1, for Bristol-Myers Squibb's drug combination that aims to treat melanoma. The annual price of the two drugs in the said combo, which both works by boosting the immune system to fight cancer, is estimated to be $256,000.
The approval of the combined Yervoy and Opdivo regimen is the first of its kind to be approved by the federal agency.
The positive decision of the FDA was obtained via an accelerated approach and was based on a clinical trial wherein more patients responded better to the combined therapy compared to Yervoy alone. In the said study, 60 percent of the participants who received the combined therapy exuded a subsequent decrease in tumor size, of whom 17 percent were cancer free. Those who were administered with Yervoy only exhibited an 11 percent response grade. The combo also extended the aggravation period of the cancer for about 8.9 months on the average. This time frame was said to be four months longer than the result for the Yervoy-only group.
"[The approval] represents our unwavering commitment to continually redefine cancer care," Bristol-Myers Squibb said in a press release. Aside from that, patients are provided with new treatment solutions, with an objective of attaining improved prognosis.
The persistent approval of the FDA depends on the whether the results of the Phase III study, which is much more extensive, will be able to replicate the existing positive outcomes. In such trial, the clinical benefit of the therapy will be further described and verified.
Yervoy and Opdivo were approved in 2011 and 2014 respectively. During the first half of 2015, the company had a profit of about $783 million from the sales of both medicines.
Melanoma is a type of skin cancer that involves the aberrant development of melanocytes, which are cells that produce pigments found in the skin. When melanoma metastasizes, it can spread from the skin to the other organs, and thus is considered to be the most fatal form of skin cancer.
In the last 30 years, the number of patients sickened by melanoma has been increasing. In 2015, the number of cases of the said disease is predicted to reach about 73,870 in the U.S.
When melanoma is diagnosed during its early phases, cure is most probable; however, if the disease is detected during its later stages, 5-year survival rate is estimated at 15-20 percent of cases and 10-year survival rate is typically noted in about 10-15 percent of patients.
