Posted from: Monday, September 17, 2018 - 12:20 PM - Present

Keytruda Receives Label Expansion, Updated Approval

August 20, 2018 – The U.S. FDA has approved an expanded label for Keytruda (pembrolizumab), manufactured by Merck. The label now shows that Keytruda, when combined with pemetrexed and platinum chemotherapy, may reduce the risk of mortality by half compared to chemotherapy alone in patients who have previously untreated non-small cell lung cancer.

In addition, the FDA granted full approval for Keytruda to be used in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients who have metastatic, non-squamous non-small cell lung cancer (NSqNSCLC) with no EGFR or ALK genomic tumor aberrations. Keytruda was initially granted accelerated approval for the indication in May 2017. Full approval was contingent upon successful completion of post-marketing research that confirmed Keytruda’s clinical benefit under the indication.

Recommended dosing to treat NSqNSCLC is 200mg delivered via intravenous (IV) infusion over the course of 30 minutes once every three weeks. In a clinical trial, patients experienced median progression free survival lasting 8.8 months on Keytruda and platinum chemotherapy, versus 4.9 months for patients who received chemotherapy alone.

Keytruda first received FDA approval in 2014. The drug is currently approved to treat more than half a dozen forms of cancer.

 

Last Updated Friday, October 19, 2018 - 01:32 AM.