Merck’s Cancer Antibody Granted Another Approval by FDA
Merck, the pharmaceutical giant with sizable operations in West Point, has received another approval for its blockbuster cancer antibody Keytruda, writes Mark Terry for BioSpace.
The Food and Drug Administration approved the checkpoint inhibitor combined with Genentech’s Herceptin and fluoropyrimidine-containing and platinum-containing chemotherapy for the first-line treatment of advanced gastric cancer.
The drug was approved based on tumor response rate and durability of response under an accelerated approval pathway.
“From the start of KEYTRUDA’s development, we have thoughtfully pursued novel combinations to help more patients with cancer,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We are pleased to bring a new first-line combination regimen with Keytruda that has shown meaningful improvement in ORR over standard treatment to patients with HER2-positive gastric and GEJ cancer.”
The company got the green light from the FDA based on data from its ongoing Phase III KEYNOTE-811 trial.
This showed a statistically significant objective response rate of 74 percent for patients who received the Merck drug compared to 52 percent of patients who only received Herceptin and chemotherapy.
In patients who were given Keytruda, the complete response rate was 11 percent, while the partial response rate was 63 percent.
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