The approval is for the use of the KEYTRUDA dosage in both monotherapy and combination therapy.
According to Merck, the FDA granted the accelerated approval of the new dosage based on pharmacokinetic data, the relationship of exposure to efficacy, and also the relationship of exposure to safety.
The company said that continued approval for the 400mg dosing could be subject to verification and description of clinical benefit demonstrated in the confirmatory trials.
Merck plans to make the new dosage option available along with the current dose of 200mg every three weeks (Q3W).
Merck Research Laboratories chief medical officer, senior vice president, and global clinical development head Roy Baynes said: “The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules.
“Today’s approval of an every six-week dosing schedule for KEYTRUDA gives doctors an option to reduce how often patients are at the clinic for their treatment.”
KEYTRUDA is an anti-PD-1 therapy, which has multiple approvals across various cancer indications in several countries, both as a monotherapy and in combination with other drugs. The drug has been approved to be used in melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, classical hodgkin lymphoma, and urothelial carcinoma among others.
The humanised monoclonal antibody is said to work by boosting the ability of the body’s immune system to help identify and fight tumour cells. It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2 to help activate T lymphocytes that could impact both tumour cells and healthy cells.