FDA gives go ahead for market introduction of a new melanoma drug combination therapy. (Photo : Getty Images/Spencer Platt)
The Food and Drug Administration has approved a new melanoma drug that experts claim as a game changer for skin cancer treatment.
Genentech, a subsidiary of Swiss drugmaker Roche, in partnership with developer Exelixis has won the FDA approval to introduce the new melanoma drug under the brand name Cotellic.
A combination Zelboraf (vemurafenib) and cobimetinib, the new drug therapy is touted as the next most significant milestone in skin cancer medication and metastatic melanoma.
Originally attributed to a group of researchers from the Los Angeles-based Jonsson Comprehensive Cancer Center, the University of California, the drug is found to be extending lives of those suffering from advanced stage melanoma, the most feared type of skin cancer. Unlike many other skin cancer drugs, the new medication does not lead to secondary malignancy in patients. Those taking single melanoma drug therapy face the increasing risk of developing secondary skin cancer following side effects.
"Today's approval is a very significant advance in the treatment of metastatic melanoma and for patients with a BRAF mutated melanoma, the combination has higher activity to shrink their tumors, and with less side effects than the drugs on their own," claims Dr. Antoni Ribas, a senior researcher at Jonsson Cancer Center.
The latest FDA melanoma drug approval preceded a comprehensive study covering 136 sites across Europe, Australia and the United States. At Jonsson, 495 patients diagnosed with BRAF V600 mutation, a type of advanced melanoma, were administered the combination therapy of cobimetinib, a MEK inhibitor, and vemurafenib, a BRAF inhibitor, the ingredients that constitute Cotellic.
About 8,000 deaths and 70,000 new cases of melanoma are reported every year in America. BRAF mutation is the most common form of skin cancer that affects more than 50 percent of these patients. This gene mutation signals malignant melanocytes neoplasms to grow constantly. Vemurafenib, the most prescribed drug for the disease, is found to be ineffective in blocking the signal completely.
Researchers discovered significantly better responses in patients treated with the new therapy. Roche markets vemurafenib under the brand name Zelboraf. The combination drug resulted in 12.3 months of progression-free survival, much higher than 7.2 months with vemurafenib alone. About 70 percent patients were reported for complete or partial shrinkage of tumors against 50 percent in placebo and vemurafenib studies.
The mortality went up to 65 percent when compared to 50 percent with vemurafenib therapy. The amazing result led the FDA to grant "priority review" status to the research trials and finally its nod for market introduction.
Among patients given the combination, 70 percent saw complete or partial shrinkage of tumors, which only 50 percent of those taking vemurafenib and the placebo saw. Additionally, 65 percent of patients on the combination were still alive 17 months after starting treatment, while those only receiving vemurafenib had a 50 percent mortality rate.
Dr. Richard Pazdur, FDA's director for Oncology Products, hailed the new skin cancer drug as a potent medication for melanoma patients. "Combining two or more treatments addressing different cancer-causing targets may help to counter the ability of malignant cells to ability to adapt and become resistant to targeted therapies and today's approval provides a new targeted treatment for patients with BRAF mutation-positive melanoma."
The new melanoma drug not only slows down the expansion malignant cells, but also prevents occurrence of secondary cancerous side effects. Past studies highlighted that one in every four skin cancer patients was likely to have secondary skin cancer when treated with vemurafenib alone.
