Sunday, December, 08, 2019 07:13:39

KEYTRUDA is approved as a monotherapy in the European Union for eight indications spanning five tumor types.

Merck, one of the leading global pharmaceutical companies recently announced that KEYTRUDA®, its anti-PD-1 therapy, has received approval from European Medicines Agency’s Committee for Medicinal Products (CHMP) for Human Use.  An extended dosing schedule for KEYTRUDA® (pembrolizumab) has apparently been approved for all monotherapy indications in the European Union.

For the record, at present KEYTRUDA is approved as a monotherapy in the European Union for eight indications spanning five tumor types.

Sources close to the matter have reported that the CHMP has come to approve a 400 mg dose of KEYTRUDA monotherapy every six weeks which should be delivered in the form of 30 minutes long intravenous infusion. The recommendation by CHMP will now have to pass through the review process of European Commission before it can obtain marketing authorization in the European Union.

The European Commission had previously approved the 200 mg dose of KEYTRUDA monotherapy every three weeks delivered in the form of 30 minutes long intravenous infusion. A final decision for the approval of the new dosage is expected to be reached in the second quarter of 2019.

Dr. Scot Ebbinghaus, VP, clinical research, Merck Research Laboratories has been reported to say that Merck remains committed to the pursuit of innovation for administering KEYTRUDA and to improving the lives of people living with cancer. Innovation in KEYTRUDA is crucial in addressing the unique needs of healthcare providers and patients.

He remarked that the positive support from CHMP indicates the approval of a six-week dosing alternative in all eight approved KEYTRUDA monotherapy across five cancer types in Europe. This is important as the KEYTRUDA 400 mg every six weeks dose is expected to provide both doctors and patients with greater treatment plan flexibility.

It should be mentioned that Merck is estimated to possess the largest immuno-oncology clinical research program in the industry.