FDA approves Genentech's Cotellic as part of melanoma combo
- The FDA has approved Cotellic (cobimetinib) to be used in combination with Zelboraf (vemurafenib) for treatment of metastatic, non-resectable melanoma. Treatment is limited to melanoma with the BRAF, V600E, and V600K abnormal gene mutations.
- Genentech also manufactures Zelboraf (vemurafenib).
- The safety and efficacy trial used as a key part of the submission dossier included 495 patients, all of whom had metastatic, non-resectable melanoma. Patients taking the Cotellic-based regimen had significantly longer progression-free survival (PFS), compared with patients treated with Zelboraf alone (12.3 months vs. 7.2 months).
Melanoma is aggressive and notoriously difficult to treat. According to estimates from the National Cancer Institute, a total of 73,870 Americans in 2015 will be diagnosed with melanoma and 9,940 will die. Increased understanding of the genetic mutations which characterize different melanoma tumors has led to more effective treatment regimens.
In addition to the positive PFS data, Genentech reported that roughly 65% of Cotellic-treated patients were alive 17 months after starting treatment, compared to the control. Cotellic represents another important addition to the melanoma treatment arsenal, and is an incremental step forward in personalized cancer treatments.