Array Biopharma Inc (NASDAQ:ARRY) has today moved ahead to make the announcement for the second quarter of fiscal 2018 results. Asides from that, it has also given an update in line with the overall progress of its major clinical development programs and it goes without saying that most of the interested parties had been waiting in much anticipation.
But what was it that could be deduced from the experimentation? Treatment using a close combination of binimetinib 45 mg twice daily (COMBO450) with encorafenib 450 mg daily was looked at more closely by the researchers. They discovered that it helped much in reducing the risk of death as opposed to the treatment using vemurafenib 960 mg daily [hazard ratio (HR) which is usually targeted at patient’s characterized with BRAF-mutant melanoma. The trial in this particular case is the Phase 3 COLUMBUS.
There was an announcement made earlier on and one notable attribute was the fact the combination of binimetinib and encorafenib from a general perspective was well-tolerated. Essentially the company has its eye fixed more on what will work best in facing out the condition than on what it spends in the long run.
An official working with the company said, “Grade 3/4 adverse events (AEs) that occurred in more than 5% of patients receiving the combination were increased gamma-glutamyltransferase (GGT) (9%), increased blood creatine phosphokinase (CK) (7%) and hypertension (6%).”
The FDA clearly understands its well cut out roles and first and foremost it will be seeking to carry out an in-depth review of Array’s New Drug Applications (NDAs) in supporting the use of binimetinib and encorafenib combination which is targeted at treating the various patients suffering from BRAF-mutant advanced, unresectable or metastatic melanoma.
Second, it will be concerning itself with targeting the action date under Prescription Drug User Fee Act (PDUFA) and it is crucial to outline that it will be for both the applications.
The Chief Executive Officer Ron Squarer while speaking to news reporters said that the obtained data was going to prove quite helpful in the whole exercise. The future looks bright, but we will just have to wait and see.