After an FDA rejection, Merck is once again awaiting an approval decision on a more convenient dosing regimen for Keytruda. Now, it has some new data to support its case—and at a time when pandemic restrictions are complicating medical care, less-frequent dosing could be more important than ever.
In a study presented virtually at the American Association for Cancer Research annual meeting, a 400mg dose of the drug given every six weeks produced a similar response rate among melanoma patients as the 200mg dose given every three weeks, “indicating similarity of efficacy” between the regimens, researchers wrote in an abstract.
The safety profiles between the two dosing schedules were comparable, too, leading investigators to determine Keytruda given every six weeks “is a safe and effective dosing regimen and offers a more convenient option for patients and physicians.”
Thanks to pharmacokinetic modeling and simulation data unveiled at 2018’s American Society of Clinical Oncology (ASCO) annual meeting, the long-acting regimen already bears approvals in markets including the EU, Australia and New Zealand.
But the FDA had other ideas when it rejected Merck’s U.S. label update back in February. “Merck is reviewing the letter and will discuss next steps with the FDA,” the company said in a statement at the time.
That discussion apparently didn’t take too long, with the New Jersey drugmaker saying last week that it had resubmitted its dosing applications across all of Keytruda’s approved indications, both solo and in combinations.
“The oncology community is rapidly adapting cancer care during the COVID-19 pandemic in order to minimize exposure and keep cancer patients as safe as possible. Now more than ever, we believe it is critical to pursue a six-week dosing schedule for Keytruda,” Roy Baynes, M.D., Merck SVP and head of global clinical development, said in a statement.
“We appreciate FDA’s guidance during the resubmission period and look forward to working closely with the agency as they continue their review,” he added.