FDA approves Braftovi capsule synthe mektovi tablets for treatment of melanoma patients

recently, Array BioPharma(announced that the U.SFood andDrug(
FDA() has approved Braftovi (binimetinib), a MEK inhibitor) combined with Mektovi (encorafenib, a BRAF inhibitor) tablet for an FDA-approvedtesting(method confirms the presence of BRAF V600E or BRAF6000notably, Braftovi is not suitable for the treatment of wild BRAF melanomaMEK and BRAF are key protein kinases in the MAPK SignalIng Pathway (RAS-RAF-MEK-ERK)Studies have shown that this pathway regulates a variety of key cellular activities, including cell proliferation, differentiation, survival, and angiogenesisIn many cancers, such as melanoma, colorectal cancer and thyroid cancer, proteins in this signaling pathway have been shown to be abnormally activebinimetinibbinimetinib is a MEK inhibitor, encorafenib is a BRAF inhibitor, both drugs are targeted at the key enzymes in this signaling pathway, Array is also evaluating the potential of binimetinib and encorafenib to treat other types of cancer, including BRAF-mutated colorectal cancerthe approval
of the Braftovi-Mektovi combination program, which is based on the results of phase III clinical studies COLUMBUS data show that the Non-Progressive Lifetime of the Braftovi-Mektovi combination was doubled compared to the Roche Black's late-stage pigmentoma drug Zelboraf (vemurafenib, Verofovini) (median PFS: 14.9 months vs 7.3 months, HR s 0.54, 95%CI: 0.41-0.71, p.0001) the study, only 5% of patients in the Braftovi-Mektovi group stopped treatment for adverse reactions, and the most common adverse reactions in the group were fatigue, nausea, diarrhea, vomiting, abdominal pain and joint pain columbus study's total lifetime (OS) analysis (data show that compared to Zelboraf (960mg, once a day), the Braftovi-Mektovi program significantly reduced the risk of death (HR-0.61,95) %CI: 0.47-0.79, p 0.0001: The bit OS in the Zelboraf single-drug group is 16.9 months, and the bit OS in the Braftovi-Mektovi scheme group is 33.6 months These positive data further enhance the clinical evidence of BRAF/MEK inhibitor combination therapy