Is Canafenib/Encofenib on the market?

Encorafenib, also known as BRAFTOVI, is a kinase inhibitor. Canafenib inhibits the BRAF gene encoding B-raf protein, a proto-oncogene involved in various gene mutations. This protein plays a role in regulating the MAP kinase/ERK signaling pathway, thereby affecting cell division, differentiation and secretion. Mutations in this gene, most commonly the V600E mutation, are the most common cancer-causing mutations in melanoma and have also been isolated in a variety of other cancers, including non-Hodgkin's lymphoma, colorectal cancer, thyroid cancer, non-small cell lung cancer, hairy cell leukemia, and lung adenocarcinoma.

On June 27, 2018, the U.S. Food and Drug Administration (FDA)approved the combination of canafenib and binimetinib (bimetinib) for use in patients with BRAF V600E or V600K mutations in unresectable or metastatic melanoma, as detected by an FDA-approved test . In September of the same year, the European Medicines Agency (EMA) decided that the benefits of canafenib outweighed its risks and it could be authorized for use in the EU. Canafenib is sold under the trade name BRAFTOVI.

Up to50% of patients with metastatic melanoma have mutations in the BRAF gene, with V600 mutations being the most common. Canafenibcombined with binimetinib can help extend the survival of these patients without making their cancer worse. Although studies in patients with NSCLC did not directly compare canafenib and binimetinib with any other treatment, in patients with BRAF V600E-mutated advanced NSCLC who had not previously received treatment, the benefits were similar to those seen with the current standard of care. Although the therapeutic effect of this combination was lower in patients who had received prior treatment, it was still considered beneficial in these patients.

In patients with previously treated colorectal cancer and BRAF V600E mutations, canafenib plus cetuximab has been shown to significantly improve their survival time. Canafenib's side effects are similar to other drugs in its class and are considered manageable.