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Merck grabs FDA green light for less-frequent Keytruda dosing regimen

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That didn’t take long. Just days after resubmitting its application to the FDA, Merck has nabbed an approval for a new dosing regimen of its immuno-oncology blockbuster, Keytruda.

The FDA green-lighted the label update Tuesday, clearing the product for use in 400mg doses every six weeks across all of Keytruda’s approved indications in both the monotherapy and combination settings.

Merck will make the new regimen available in addition to the current dose of 200mg every three weeks, but it’ll represent a much more convenient—and safe, amid the COVID-19 pandemic—option for patients, who will have to come in twice as often to receive the drug.

“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” Roy Baynes, M.D., Merck SVP and head of global clinical development, said in a statement, adding that new OK “gives doctors an option to reduce how often patients are at the clinic for their treatment.”

The pandemic is hurting many drugmakers as patients do their best to stay away from treatment centers and hospitals pivot to battle COVID-19. But earlier Tuesday, Merck said it would be hit especially hard thanks to a portfolio heavy on physician-administered drugs—Keytruda included.

The company expects a $2.1 billion hit to 2020 sales in human and animal health products from the pandemic, it said.

Meanwhile, the nod comes just five days after the New Jersey drugmaker resubmitted its application to the FDA after a February rejection. The company never provided a reason for the agency’s cold shoulder, saying at the time simply that it was reviewing the complete response letter it had received and would discuss next steps with regulators.

It also follows close on the heels of data presented virtually at the American Association for Cancer Research annual meeting, which showed the two dosing regimens had produced similar response rates among melanoma patients, “indicating similarity of efficacy,” researchers wrote in an abstract.

 

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Thanasis Chalikias Προβολή όλων

A Product Manager with expertise in pharma marketing and sales operations

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