March 5, 2019 / Bio Valley BIOON / -- Cancer immunotherapy giant Merck & Co recently announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued positive comments，recommending approval of PD -1 Tumor Immunotherapy Keytruda (Credida, Generic Name: pembrolizumab, Pabolizumab)，a new extended dosing regimen for all approved monotherapy indications in the European Union. In the European Union, Keytruda has been approved as a single-agent therapy for eight indications for five tumor types.
The positive opinions of CHMP support a new recommended dose of Keytruda monotherapy, 400 mg (Q6W) every six weeks, given intravenously for no less than 30 minutes. CHMP's comments will now be submitted to the European Commission (EC), which will make a final review decision in the second quarter of 2019. If approved, the Q6W dosage regimen will provide another dosage regimen in addition to the currently approved 200 mg (Q3W, intravenous infusion, no less than 30 minutes) every three weeks.
Dr. Scot Ebbinghaus, Vice President of Clinical Research at Mershadon Research Laboratory, said, "Mershadon is still committed to improving the lives of cancer patients, including seeking innovative treatment options to meet the unique needs of patients and health care providers. Importantly, the positive view of CHMP supports the approval of a six-week dose regimen for all eight approved Keytruda monotherapy indications in Europe involving five types of cancer. If approved by EC, the Keytruda regimen of 400 mg per six weeks will provide doctors and patients with greater flexibility in treatment planning.
Keytruda is an anti-PD-1 cancer immunotherapy that helps detect and combat cancer cells by improving the ability of the human immune system. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L 1 and PD-L2, thereby activating T lymphocytes that may affect cancer cells and healthy cells.
Mosadong has the largest clinical research project on immune tumors in the industry. Currently, more than 900 clinical trials have studied Keytruda in a variety of cancer and treatment environments to explore its role in cancer treatment and to predict the factors that patients can benefit from Keytruda treatment, including the exploration of several different biomarkers.