Cobimetinib (Cotellic)

Combination of Cotellic and Zelboraf

A new treatment option for patients with advanced melanoma.

Cobimetinib (Cotellic) approved in combination with vemurafenib (Zelboraf) for the treatment of advanced melanoma that spread to other parts of the body or is unable to be removed via surgery, and has a specific abnormal BRAF, V600E, or V600K gene mutation.

Studies demonstrate greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma.

Cobimetinib acts through blocking MEK enzyme activity as part of a larger signaling pathway.

Vemurafenib treats a different section of the same signaling pathway affected by cobimetinib

The BRAF V600E or V600K mutation should first be confirmed in tumor specimens prior to initiating treatment with this combination.

In a randomized clinical trial of 495 patients with previously untreated BRAF V600 mutation-positive melanoma that is advanced or is not able to be removed by surgery administered vemurafenib and were randomly selected to also receive cobimetinib or placebo: showed a 12.3 month average delay in disease progression after starting treatment compared with approximately 7.2 months after starting treatment in the vemurafenib with placebo group.

In the above study patients in the Cotellic plus vemurafenib group had longer overall survival, as approximately 65% of patients were still alive after 17 months after starting treatment compared with 50% in the vemurafenib with placebo group.

In the above study 70% of patients in the cobimetinib plus vemurafenib group showed complete or partial tumor shrinkage compared with 50% in the vemurafenib plus placebo group.

Common adverse events from the cobimetinib with vemurafenib combination are diarrhea, sensitivity to ultraviolet light, nausea, fever, and vomiting.

Additionally, cobimetinib may cause side effects, including cardiomyopathy, rhabdomyolysis, primary cutaneous malignancies, eye disease, severe skin rash, hepatotoxicity, hemorrhage, and severe skin rash from increased photosensitivity.

Patients treated with cobimetinib should avoid sun exposure, wear protective clothing, and a broad spectrum ultraviolet A/ultraviolet B sunscreen.

The drug can harm a developing fetus.

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