The U.S. Food and Drug Administration has approved Opdivo as a treatment for advanced squamous non-small lung cancer (NSCLC). It works by inhibiting the cellular pathway known as PD-1 protein cells, which blocks the body’s immune system from attacking cancerous cells. This is known as immunotherapy where the body fights off the disease itself.
“What these drugs do in a sense is release a brake that’s put on the immune system by the cancer, explained Dr. Scott Gettinger of New Haven. “The drug allows the immune system to attack the cancer.” The hope is for other cancers, such as mesothelioma, (the aggressive cancer affecting the membrane lining of the lungs and abdomen,) to share similar results.
The approval was accelerated by three months and is the second one in the U.S. within the last three months with Bristol-Myers Squibb leading the development of the injection. The FDA worked closely with the company to facilitate the early submission and review of the clinical trial when results became available in December 2014. Both claim it’s the first and only therapy proven to extend survival rates for patients who have already received prior platinum-based chemotherapy.
The clinical trial’s results were specific to Opdivo’s treatment of advanced (metastatic) squamous non-small cell lung cancer. Of 117 participants, 15% experienced partial shrinkage or complete disappearance of their tumor.
Janet Thompson, age 64, from Milwaukie, was one of the participants who’s grateful to Opdivo for shrinking her tumor. Thompson does require an infusion treatment of the drug every two weeks for an hour and a half, but she has experienced no side effects. Plus, she has since resumed her usual activities of traveling, quilting, reading, and spending time with her children, grandchildren, and great-grandchild.
“This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Following approval, 272 individuals participated in a randomized trial, again, for advanced (metastatic) squamous non-small cell lung cancer. 135 received Opdivo and 137 were given docetaxel. The Opdivo patients lived an average of 3.2 months longer than the docetaxel participants.
Dr. Roy Herbst, Chief of Medical Oncology at the Yale Cancer Center is calling the new treatment “miraculous.” In his 25 years he’s “never seen anything like it.” Patient Maureen O’Grady, age 62, from Milford, saw results within a month of starting therapy. Patient Joe New, age 60, from Bristol, had lost part of both his lungs and cancer had spread to his liver. After a mere four weeks of treatment his cancer was gone.
Bristol-Myers Squibb’s main competitor, Merck, has also received FDA approval for its version of the drug called Keytruda®. Its effectiveness is being studied across more than 30 types of cancer and although an improvement in survival or disease-related symptoms has not been released, Merck was also granted accelerated approval based on tumor response rates and durability of response.