Merck claims FDA approval for six-week Keytruda dosing

Merck & Co has finally secured FDA approval for a new six-week dosing regimen for Keytruda that can be used across all its approved indications, and could make it easier to dose the drug during the coronavirus pandemic.

Keytruda (pembrolizumab) is already leading the cancer immunotherapy market with its current 200mg dosing every three weeks, with sales of the drug rising 45% to $3.3bn in the first three months of 2020 and driving group sales up by 11% to $12.1bn.

The problem facing Merck is that Keytruda and many other drugs in its portfolio are generally prescribed by physicians after face-to-face meetings in doctors’ offices, which are being hit by COVID-19 lockdowns.

Merck said this week that the pandemic could reduce its 2020 sales by more than $2bn, as two-thirds of its products are healthcare provider-administered, and as a result lowered its profit forecasts for the year.

The new Keytruda regimen of 400mg every six weeks applies to all approved monotherapy and combination regimens will help overcome the challenges posed by lockdown measures, such as keeping to planned treatment schedules, said Merck’s chief medical officer Dr Roy Baynes.

“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer,” he added. “A dosing schedule of every six weeks for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment.”

Merck previously filed for approval of the new regimen with the FDA, but that application was rejected in February, with the agency saying it was unable to approve the filing in its current form.

The FDA approval comes just a few days after a second application was filed, and more than a year after the six-week regimen was approved by the EMA for  Keytruda’s monotherapy indications only.

Thankfully for Merck its vaccine sales also proved resilient to the impact of COVID-19 in the first quarter, rising 14% to $2.2bn, and the company said overall the pandemic’s effect in the first quarter was “immaterial”.

It thinks the big hit will come in the second quarter, with vaccines and Keytruda both affected, but is hoping for a recovery before the end of the year and a bounceback in 2021 as the pandemic abates.