The gist: A new pancreatic cancer treatment combines two drugs, known as CRS-207 and GVAX Pancreas. This combo treatment boosts a patient’s own immune system to fight cancer. It has been tested in volunteer patients in clinical trials, and has shown promising results for people with metastatic pancreatic cancer. The U.S. Food and Drug Administration (FDA) has now granted breakthrough therapy designation for CRS-207 plus GVAX Pancreas, meaning that review and approval will be accelerated so that the drug can more quickly reach patients in the U.S., outside of clinical trials.
“The FDA today granted breakthrough therapy designation to the combination of two immunotherapies — CRS-207 and GVAX Pancreas — for the treatment of metastatic pancreatic cancer, according to Aduro BioTech, the combination treatment’s manufacturer.
“The combination of GVAX, an irradiated, granulocyte-macrophage colony–stimulating factor vaccine, and CRS-207, an immunotherapy vaccine containing live-attenuated Listeria monocytogenes bacteria, induces a potent innate and T-cell–mediated immune response.
“ ‘We are extremely pleased to receive Breakthrough Therapy Designation and the high degree of FDA collaboration toward advancement of our program that it confers,’ Stephen T. Isaacs, chairman, president and CEO of Aduro, said in a press release. ‘This designation underscores the potential of our combination immunotherapy approach to make a difference in the lives of patients with pancreatic cancer, which remains a very difficult cancer to treat. We are encouraged by our phase 2 results and look forward to completing enrollment in our phase 2b ECLIPSE trial by end of 2015.’ “