Cotellic gains FDA approval as combination melanoma treatment
Also known as cobimetinib, Cotellic is a prescription medicine used with the company's other drug Zelboraf (vemurafenib) to treat melanoma that has either spread to other parts of the body or can't be removed by surgery and has an abnormal BRAF gene as confirmed by an FDA-approved test. Cotellic prevents or slows the growth of cancer by blocking the activity of a type of protein called MEK that is found in the cell-signaling pathway responsible for controlling cell division and survival.
Zelboraf, approved by the FDA in 2011, inhibits mutated forms of the BRAF protein which is also part of the signaling pathway.
A clinical study involving 495 individuals showed that taking Cotellic in combination with Zelboraf delayed the progression of melanoma by approximately a year compared to a little more than six months for those only taking Zelboraf. Moreover, people taking the combination treatment lived longer and saw a complete or partial shrinkage of their tumors.
“As we continue to advance our knowledge of tumor biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies," Richard Pazdur, director of the office of hematology and oncology products in the FDA's Center for Drug Evaluation and Research, said. "Combining two or more treatments addressing different cancer-causing targets may help to address this challenge. Today’s approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma."
Melanoma, the most aggressive type of skin cancer, affects more than 73,000 individuals in the United States and causes more than 9,000 deaths each year.