Merck, which is known as MSD outside of Canada and the United States has announced that, the US FDA has approved for reviewing a new supplemental Biologics Licence Application (sBLA) seeking a new review for the Keytruda for the treatment of the patients with the non-small cell lung cancer followed by the complete surgical resection.
The US FDA has also set a Prescription Drug Oncology Fee Act (PDUFA) and although the data might also be provided during the review process that might delay this date. The Keytruda has been an anti-programmed death receptor-1 (PD-1) therapy that has been working by increasing the ability of the immune system of the body for providing help in detecting and fighting the tumor cells.
The keytruda has been a humanized monoclonal antibody that mainly blocks the interaction between PD-1 and its ligands and the PD-L1 and PD-L2 and then activating T lymphocytes which might be affecting both the tumor cells and also healthy cells.
The study has been dual primary endpoints of the disease-free survival (DFS) regardless of the PD-L1 expression and the DFS in the patients whose tumors have been expressing the PD-L1.
Dr. Eliav Barr, senior vice president, chief medical officer and head of global clinical development said, the Keytruda has been foundational in the treatment of the metastatic non-small cell lung cancer and the acceptance of their application that has been demonstrating the progress in which they are making in the previous lines and earlier stages of certain cancers across their portfolio of Oncology.