This type of FDA designation expedites regulatory review for drugs if they “demonstrate substantial improvement” compared to drugs already on the market, the Thousand Oaks company said.
The drug, called bemarituzumab, is the second of Amgen’s oncology portfolio to receive the designation; the first was its KRAS G12C inhibitor, a drug to treat non-small cell lung cancer.
The therapy garnered FDA attention through a clinical trial evaluating the effectiveness of the drug in combination with chemotherapy, versus chemotherapy by itself.
“Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy,” Dr. David Reese, vice president of research and development at Amgen, said in a statement.
Added Reese: “Amgen looks forward to further investigating the role of (this treatment) and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients.”
More than 1 million new gastric cancer cases are diagnosed annually, Amgen said. The disease is “particularly prevalent” in Asia, where Amgen seeks to expand its global footprint, according to previous earnings calls.
Shares of Amgen (AMGN) closed up $3.17, a little more than 1 percent, to $259.14 on the Nasdaq on Tuesday, a day when the overall Nasdaq was down less than a percent.