FDA approves new skin cancer drug after a study conducted on the effects of the drug shows promising results. The drug combination used was found to extend the life expectancy of patients suffering from an advanced form of the disease without the existence of a side effect in the form of a secondary skin cancer, shown by patients who only took one of the drugs used in the new combination treatment.
Dr. Antoni Ribas, senior investigator in the study and a researcher at the Jonsson Comprehensive Cancer Center at UCLA explains that the approval of the treatment marks an important step in the treatment of melanoma, a dangerous form of skin cancer. The drug combination helped reduce tumors in patients with advanced stages of the disease if it was caused by a BRAF mutation.
The drug combination that was tested is made up of two main substances: vemurafenib, known as Zelboraf on the market, and cobimetinib, known as Cotellic. It was tested on almost 500 patients who suffered from an advanced stage of melanoma caused by a BRAF mutation and many of the patients participating in the trial showed an improved response to the combination of drugs than to the vemurafenib alone.
The study was granted a “priority review” status because of the positive response participants had to the combination even in the early stages of the research project and it has now also been approved for use on patients with advanced stage melanomas. So far, the study has proven that when the second drug, cobimetinib, is added to the vemurafenib, the growth of the melanoma is slowed down considerably in comparison to treatment courses that only include the latter.
A previous study had also shown that 25 percent of the patients receiving only the vemurafenib developed secondary skin cancer as a side effect of the treatment. According to the new study conducted at UCLA, the addition of the cobimetinib to the vemurafenib treatment reduced the frequency of the appearance of this secondary skin cancer.
The new Cotellic and Zelboraf treatment combination has also been recently recommended by the Committee for Medicinal Products for Human Use (CHMP) for approval in the European Union. The treatment is waiting for approval in Europe, but it has already been given the green light in Switzerland by the Swiss regulator.
The new treatment combination opens up new possibilities for the use of multiple treatment courses when treating skin cancer, as cancer cells were found to have a very advanced ability to adapt and resist therapies in time. This technique of combining different treatments could lead to offering better treatment to cancer patients and lead to more personalized treatment options in the future.
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