MSD’s drug given European approval for first-line treatment in NSCLC

pharmafile | February 1, 2017 | News story | Sales and Marketing European Commission, MSD, Merck 

The good news keeps coming for MSD, known as Merck in North America, and Keytruda, with a further label expansion across all 28 EU member states. Keytruda will now be able to be used in first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have high PD-L1 expression.

The approval was based on Phase 3 data gleaned from 305 patients that used Keytruda as a monotherapy, who had not received prior systemic chemotherapy treatment for their metastatic disease, whose tumours had high PD-L1 expression and had no EGFR or ALK aberrations. The studies demonstrated that Keytruda was superior to previous first-line chemotherapy treatment, with the results displaying that Keytruda reduced the risk of death by 50% and improved progression-free survival by 4.3 months

“The approval of Keytruda as a first treatment instead of chemotherapy for patients who express high levels of PD-L1 has the potential to transform the way metastatic non-small cell lung cancer is treated,” said Dr. Roy Baynes, Senior Vice President, Head of Clinical Development, and Chief Medical Officer at Merck. “We are committed to ensuring that patients in Europe – who are in need of new treatment options – are able to quickly gain access to Keytruda.”

This approval comes three months after the same indication was given approval in the US. The steady expansion of its label comes as the gap between Keytruda and Opdivo is beginning to narrow, with MSD reporting sales of $919 million for the first nine months in 2016 against Opdivo’s sales of $920 million.

Ben Hargreaves

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