The government has approved a cancer treatment for patients with solid tumors that include biomarkers.
The Food and Drug Administration announced this week it granted approval for Keytruda, which is for adult and pediatric patients with "unresectable or metastatic solid tumors" that have these biomarkers.
A biomarker is a substance in a person's body that can be measured to tell doctors something about an individual's health.
The approval of this treatment is a big deal in the cancer community, Dr. Richard Pazdur said on behalf of the FDA.
“Until now, the FDA has approved cancer treatments based on where in the body the cancer started — for example, lung or breast cancers. We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location," Pazdur said in the FDA's announcement published online.
Keytruda "works by targeting the cellular pathway knows as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells)," the announcement says. The treatment may help the body's immune system fight the cancer cells.
This drug is what former President Jimmy Carter credits with shrinking his brain tumors completely.
To test Keytruda's safety and efficacy, 149 patients were studied in clinical trials. The most common types of cancer among these patients were colorectal, endometrial and other gastrointestinal cancers.
"Of the 149 patients who received Keytruda in the trials, 39.6 percent had a complete or partial response. For 78 percent of those patients, the response lasted for six months or more," the FDA said.
Read the FDA's full Keytruda approval announcement here.
