Combination immunotherapy for advanced melanoma approved by the FDA
Combination immunotherapy for advanced melanoma approved by the FDA1 Oct 2015
The Melanoma Research Alliance (MRA) has welcomed the U.S. Food and Drug Administration (FDA)'s decision to approve the use of Bristol-Myers Squibb’s nivolumab and ipilimumab in combination as a treatment for patients with unresectable or metastatic melanoma without a BRAF mutation, known as BRAF wild-type melanoma.
Approximately half of patients’ melanomas harbor BRAF mutations and the other half are BRAF wild-type.
The first approval of combination immunotherapy for advanced melanoma
The FDA’s accelerated approval of the two-drug regimen marks the first approval of combination immunotherapy treatments for advanced melanoma and comes less than one year after the first approval of nivolumab by the FDA.
Ipilimumab and nivolumab are two types of immunotherapy that help the body’s own immune system attack cancer cells. Ipilimumab is an anti-CTLA-4 inhibitor, while nivolumab is an anti-PD-1 drug; each was previously FDA-approved as monotherapy for the treatment of advanced melanoma.
A rapidly changing treatment landscape for melanoma patients
The decision by FDA was based on the results of the CheckMate-069 trial, which looked at the combination of ipilimumab and nivolumab as compared to ipilimumab alone in previously untreated, BRAF wild-type patients. Recently reported studies showed the use of these two therapies in combination yielded better results than ipilimumab on its own in previously untreated melanoma patients – the so-called first-line setting.
“The FDA’s latest approval signifies the rapidly changing treatment landscape for patients with melanoma,” said Debra Black, MRA Co-Founder and Chair of the Board. “We have more work to do to improve the survival rates for patients with advanced melanoma, particularly as rates of melanoma continue to rise, but this is an important decision that has the potential to benefit many patients.”Source: eCancer News