FDA approves another indication for Keytruda, this time in the adjuvant NSCLC setting
Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.
The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.
According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.
The FDA stated that adverse reactions were about the same between the drug and control arms, with cases of hypothyroidism and pneumonitis being reported. There were two fatal reactions of myocarditis reported in the trial as well.
“With this approval, KEYTRUDA offers a new, important immunotherapy treatment option for stage IB (T2a ≥4 cm), II, or IIIA patients with non-small cell lung cancer following surgery and adjuvant chemotherapy. This provides, for the first time, an adjuvant immunotherapy treatment option for non-small cell lung cancer patients with stage IB disease and regardless of PD-L1 expression,” Merck said in an email to Endpoints News.
Keytruda is not stopping there as, according to Merck’s email to Endpoints, the drug has been accepted for priority review in combination with Padcev for treating patients with advanced or metastatic urothelial cancer who are not eligible for receiving chemo. The PDUFA date for that is set for April 21.
The good news has kept rolling in for Merck’s top seller. Toward the end of 2022, the anti-PD-1 antibody had a less-frequent dosing regimen, previously cleared by the FDA under accelerated approval, converted into full approval. That accelerated approval allowed for the dosing of patients once every six weeks with 400 mg of the drug as opposed to 200 mg every three weeks.
On the sales front, Keytruda sales grew to $5.4 billion on Merck’s Q3 report, but a preview report from Evaluate showed that Keytruda sales are expected to add almost $3 billion. This is on top of the $20.89 billion in 2022 sales.
Editor’s Note: An earlier version of this story stated that Keytruda has 33 indications. The article has been corrected to note that the latest indication brings the total to 34.