The US Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications to update the dosing frequency for United States-based Merck's KEYTRUDA, the company's anti-PD-1 therapy, to include an every-six-weeks dosing schedule option, it was reported yesterday.
The company is seeking FDA approval for a 400mg Q6W dose infused over 30 minutes for KEYTRUDA indications in melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma.
If the product is approved, the Q6W dose is to be available for use in adults in addition to the presently approved dose of KEYTRUDA 200mg every three weeks infused over 30 minutes. The FDA has set a Prescription Drug User Fee Act, or target action, date of 18 February 2020. The product is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumour cells. It is a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumour cells and healthy cells.
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress
Cumberland Pharmaceuticals reports ifetroban Phase 2 DMD heart disease trial results
Sarclisa recommended for EU approval in newly diagnosed transplant-eligible multiple myeloma