According to an article at publicnow.com, the FDA has granted Breakthrough Therapy Designation to avelumab combined with INLYTA (axitinib) for people with advanced renal cell carcinoma. This designation should accelerate development and review for treatments for serious illnesses.
The combination treatment should offer a substantial improvement over currently available therapies available for the treatment of renal cell carcinoma. Currently, the five year survival rate for the disease is still very low. This disease is a cancer of the kidney. While the cancer is generally rare, it is the most common type of kidney cancer found in adults. Although the five year survival rate is actually pretty high if the cancer has not spread deeper into the kidney tissue or into other parts of the body, the symptoms are often hidden, which means that the cancer is typically already advanced upon discovery. Symptoms include bloody urine, high blood pressure, night sweats, and noticeable mass in the abdomen, flank pain, weight loss, and fever. To learn more about renal cell carcinoma, click here.
Despite the new designation and the positive results so far, the combination is still undergoing trials, and there is still no guarantee that the treatment will be made available. The study utilized patients with advanced forms of the cancer from around the world, including patients from the United States, the United Kingdom, and Japan. A total of fifty-five people participated in the trial.
Avelumab is designated as a human anti-programmed death ligand-1 antibody. A form of immunotherapy, the treatment was developed by an international collaboration of drug companies and organizations, including Pfizer, Merck KGaA, and Darmstadt, Germany. The treatment is meant specifically for those patients whose cancer has metastasized, or spread to other organs or systems of the body. While showing promising signs, BAVENCIO (avelumab), can still cause potentially harmful and even fatal side-effects. However, side effects of this severity only occurred in around one percent of patients who had received the treatment.
The new FDA designation represents another step in the regulatory process for the new treatment, and its approval would expand the very limited treatment options for renal cell carcinoma.