A Supplemental Biologics License Application was submitted for Keytruda for the treatment of lung cancer.
The FDA recently accepted Merck’s Supplemental Biologics License Application for pembrolizumab (Keytruda) for the first-line treatment of advanced non-small cell lung cancer, assigning the drug Priority Review status.
Keytruda was previously granted Breakthrough Therapy Designation for this indication, according to Merck. Additionally, a Marketing Authorization Application has also been submitted to the European Medicines Agency. Keytruda is a humanized monoclonal antibody that inhibits the interaction between PD-1 and its ligands, activating T cells.
The new submissions were based on findings from the KEYNOTE-024 phase 3 clinical trial. Included in the study were 305 previously untreated patients with advanced non-small cell lung cancer whose tumors expressed high levels of PD-L1.
Patients were randomized to either receive 200-mg of Keytruda every 3 weeks, or platinum-based chemotherapy. Researchers found that Keytruda monotherapy every 3 weeks resulted in increased progression-free survival and overall survival compared with standard chemotherapy.
Due to an overwhelmingly beneficial response, the trial was stopped early so all patients could receive treatment with Keytruda.
“We believe that the KEYNOTE-024 results have the potential to change the therapeutic paradigm in first-line treatment of non-small-cell lung cancer,” said Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories in a press release announcing the results in June. “We look forward to sharing these data with the medical community and with regulatory authorities around the world.”
Keytruda has already received FDA-approval for melanoma, lung cancer, and head and neck cancers. The drug has also been granted breakthrough status for patients with advanced melanoma, non-small cell lung cancer in previously treated patients, microsatellite instability high metastatic colorectal cancer, and relapsed or refractory classical Hodgkin Lymphoma, according to the study.
“Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with KEYTRUDA compared to chemotherapy is welcome news,” Dr Perlmutter said about the recent filings. “We appreciate the opportunity to work with regulatory authorities to make Keytruda a first-line treatment option in non-small cell lung cancer.”