AVEO Pharmaceuticals, Inc. [NASDAQ: AVEO] disclosed that it has received FDA authorization for the treatment of sufferers suffering from relapsed or refractory advanced renal cell carcinoma (RCC) with FOTIVDA. There is one main condition is that the sufferers may get two or more previous systemic therapies.
After the FDA approval, FOTIVDA will work like a ray of hope for the sufferers who are experiencing kidney cancer. FDA’s authorization to FOTIVDA based on the pivotal Phase 3 study, TIVO-3, of AVEO comparing FOTIVDA to sorafenib in relapsed or refractory advanced RCC after two or more previous systemic therapies.
The application of authorization is also backed by three additional trials in RCC and also comprises safety data from over 1,000 clinical trial participants. The victims who have participated in TIVO-3 have randomly received either FOTIVDA or sorafenib. The adverse events which are firm has observed are hypertension, diarrhea, cough, nausea, and fatigue.
Furthermore, the firm has suggested the appropriate dose of FOTIVDA which is 1.34 mg once daily with or without food for 21 days every 28 days. AVEO has disclosed that the victims will be able to access the drug by March 31, 2021, in the US. Relapsed or refractory RCC is currently a horrible disease. The authorization of the FDA is a greater accomplishment for AVEO who strived to provide better cures to the victims. AVEO is expecting that this new treatment will play a significant role in the treatment of relapsed or refractory RCC.