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Tecentriq Receives New Melanoma Indication

July 30, 2020 – The U.S. FDA has approved a new indication for Tecentriq® (atezolizumab), manufactured by Genetech. Tecentriq is now indicated for use with Genetech’s Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) to treat BRAF V600 mutation-positive unresectable or metastatic melanoma.

Melanoma accounts for only 1% of all skin cancer diagnoses in the United States, but is the most lethal form, responsible for the majority of skin cancer deaths. Approximately half of all advanced melanomas are BRAF mutation-positive, with BRAF V600 mutations being the most common. The mutations are associated with the growth of cancer cells and can make the cancer more aggressive.

In a clinical study, patients treated with Tecentriq, Cotellic, and Zelboraf had a median progression-free survival time of 15.1 months compared to 10.6 months in patients who received a placebo plus Cotellic and Zelboraf. The combination of Cotellic and Zelboraf is a current standard of care for BRAF V600 mutation-positive unresectable or metastatic melanoma.

Prior to starting treatment with Tecentriq under the new indication, patients should receive a 28-day treatment cycle of Cotellic and Zelboraf. The recommended dose of Tecentriq is 840mg administered via intravenous infusion over the course of one hour every two weeks until disease progression or unacceptable toxicity occur. If the first infusion of Tecentriq is tolerated, subsequent infusion times can be reduced to 30 minutes. Treatment with Cotellic and Zelboraf should continue on a 28-day cycle while the patient is receiving Tecentriq.

First FDA approved in 2016, Tecentriq is also indicated to treat urothelial carcinoma, non-small cell lung cancer, small cell lung cancer, triple-negative breast cancer, and hepatocellular carcinoma.