Two-drug combo was approved by FDA to treat metastatic melanoma following the results of clinical trials suggesting the combination is highly effective.
The two-drug combo was awarded priority review status due to the outstanding results observed in the clinical trials. The FDA has now approved the combination as it both slows tumor growth and prevents new tumors from growing with far less side effects than treatment prescribing just one drug.
The two drugs are Zelboraf and Cotellic. These are the market names of vemurafenib and cobimetinib. Zelboraf is a drug prescribed to patients with melanoma spreading rapidly to different parts of the body than the initial site. Typically tumors treated with Zelboraf present a gene mutation dubbed BRAF V600E. These mutation is responsible for continuous growth of melanoma into cancer. While it has some success, Zelboraf isn’t fully capable of halting the growth of melanoma by itself.
Cotellic is used to block an enzyme dubbed MEK which also enables cancer cells to grow. Now, two-drug combination was approved by FDA to treat metastatic melanoma. Researchers with the University of California at Los Angeles created a different treatment combining Zelboraf and Cotellic. The clinical trial included 495 patients in a randomized study. All patients presented BRAF V600E mutation melanoma. None of them had been previously treated as the cancer could either not be removed through surgery or it was too advanced.
All 495 patients were treated with vemurafenib. Then each patient received randomly a placebo or cobimetinib. Patients who were treated with the two-drug combo showed no sign of worsening for an average of 12.3 months following the treatment. Patients who were only treated with the placebo-vemurafenib showed only 7.2 months of stabilization.
In the group treated with the two-drug combo, 70 percent presented either a complete or a partial tumor shrinkage. Only 50 percent of the second group showed the same result. 50 percent of the patients treated with vemurafenib died, while 65 percent of those treated with both drugs were still alive after 17 months from the treatment.
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