FDA grants breakthrough designation to new pancreatic cancer treatment

byetta FDA grants breakthrough designation to new pancreatic cancer treatmentA new pancreatic cancer combination treatment has been granted Breakthrough Therapy Designation by the Food and Drug Administration (FDA), giving new options for patients with metastatic pancreatic cancer.

A breakthrough therapy designation is designed to expedite drug development for therapies that treat serious or life-threatening conditions.

The new treatment, manufactured by Aduro BioTech, is a combination of CRS-207 and GVAX Pancreas immunotherapies. The designation was granted based on findings from a phase 2 clinical trial involving metastatic pancreatic cancer patients. The randomized, controlled, multi-center study involved 93 patients who had either failed or refused prior therapy.

The study showed a statistically significant survival benefit in patients receiving the combination drug compared to patients who received the GVAX Pancreas vaccine alone. The median overall survival in patients who received the combination treatment was 6.1 months compared to 3.9 months for those who were given the single treatment.

Pancreatic cancer is one of the most deadly forms of the disease, killing 95 percent of patients within five years of diagnosis. Factors that increase the risk of pancreatic cancer include obesity, tobacco use, diabetes and chronic pancreatitis, a painful inflammation of the pancreas. Exposure to chemicals and medications can also increase risk. For example, the type 2 diabetes drugs Januvia and Byetta have been linked to acute pancreatitis and pancreatic cancer.

Source: PharmPro