The FDA approves pembrolizumab for use at an additional recommended dose of 400 mg every six weeks for all previously approved adult indications

On April 28, 2020, the U.S. Food and Drug Administration (FDA) granted approval to pembrolizumab for use at an additional recommended dose of 400 mg every six weeks for all previously approved adult indications. This includes the treatment of adult patients with refractory classical Hodgkin lymphoma (cHL), patients with cHL who have relapsed after ≥ 3 prior lines of therapy, patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), and patients with PMBCL who have relapsed after ≥ 2 prior lines of therapy. The current dosing regimen is 200 mg of pembrolizumab intravenously every 3 weeks; this new dose option will be available to supplement the current dose.¹

Pembrolizumab is a humanized monoclonal antibody that binds to programmed cell death-1 (PD-1) receptor and blocks interaction with its ligands PD-L1 and PD-L2, resulting in the activation of T lymphocytes. The new dosage approval was granted based on pharmacokinetic modeling, exposure-response, and exposure-safety data from a trial that aimed to determine whether a longer dosing interval would provide greater flexibility and convenience to patients and their healthcare providers.  Overall, 400 mg pembrolizumab administered every 6 weeks demonstrated similar pharmacokinetics and safety to the dose already approved by the FDA.²

The continued approval of the 400 mg dosage may be contingent upon verification of patient benefit in future confirmatory trials.¹

Read our previous coverage of pembrolizumab’s FDA approval here and EMA approval here.