“The era in which chemotherapy is the only option for non-small cell lung cancer patients is drawing to a close,” John Heymach, an oncologist at MD Anderson Cancer center who was not involved in the trial, tells Reuters.
Manufactured by Merck, Keytruda is already approved for a slew of cancers including non-small cell lung cancer (NSLC) and melanoma. Keytruda interferes in a pathway that helps protect cancer cells from immune action and boosts the body’s natural immune response.
In the melanoma trial, around 90 percent of patients with advanced cancer experienced a pause in disease progression after two years of treatment with the immunotherapy drug.
The lung cancer data came from two trials. One included 1,274 cases of advanced NSLC whose cells produce a protein called PD-L1. Solely taking Keytruda as an anti-cancer intervention, patients lived on average 16.7 months, four months longer than those on chemotherapy. In another trial of 559 patients, those given Keytruda in combination with chemotherapy lived on average 15.9 months compared to 11.3 months for those on chemotherapy alone.
At the ASCO meeting, Scott Gottlieb, the commissioner of the US Food and Drug Administration (FDA), mentioned that the FDA is reconfiguring its approval process to foster the rapid entry of new drugs into the cancer market and facilitate new applications for old drugs. According to Reuters, Gottlieb calls the revised format a “real-time oncology review” that is designed to address problems with clinical trial data before companies submit their applications for review. Already being used in cases where approved drugs are being repurposed, the FDA plans to apply the same process to new drugs.