Cotellic approved for advanced melanoma

The United States Food and Drug Administration approved Cotellic (Cobimetinib) as a combined therapy with Vemurafenib for advanced melanoma treatment that is metastatic or cannot be surgically removed in patients with abnormal gene mutations (BRAF V600E or V600K). Cotellic is a MEK blocker that is involved in cancer pathogenesis.
 
Cotellic was approved with orphan drug designation and reviewed based on FDA’s priority review program.
 
Randomized clinical trials involving 495 treatment-naïve patients were included. The subjects were randomly assigned to receive Cotellic or Vemurafenib plus placebo. Delayed worsening of disease by 12.3 months was observed in treatment group compared with 7.2 months in Vemurafenib-only patients. Complete or partial shrinkage of tumors were observed in 70% of patients in combined therapy group, compared to 50% subjects in the comparator arm.
 
Some of the reported common adverse events are photosensitivity, diarrhea, nausea, vomiting and fever. Other severe side effects include rhabdomyolysis, severe skin rashes, hemorrhage, cardiomyopathy and hepatotoxicity.