Merck & Co has been given approval in Europe for its checkpoint inhibitor Keytruda (pembrolizumab) as a treatment for melanoma.
The go-ahead by the European Commission is for use of the PD-1 antagonist both as a first-line treatment of melanoma, as well as for patients who have previously been treated with other drugs.
It comes a month after Bristol-Myers Squibb’s rival drug Opdivo (nivolumab) was approved for the same indication.
Keytruda has been cleared on the back of data which showed that the drug was significantly more effective than BMS’ older immuno-oncology drug Yervoy (ipilimumab) in extending survival in melanoma patients.
Merck says the drug is the first anti-PD-1 drug to show a survival benefit compared to Yervoy, which achieved sales of $1.3bn last year.
Roger Perlmutter, president of Merck Research Laboratories, said: “Today’s European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world.
“We believe that the broad data set supporting this approval helps illustrate the significant potential of Keytruda to treat advanced melanoma, a devastating disease.”
Keytruda is also approved to treat melanoma in the US and has also been granted a priority review as a therapy for non-small cell lung cancer (NSCLC), with a decision on the latter indication due by October 2.
While Keytruda was the first PD-1 inhibitor to reach the market in the US, although Opdivo claimed that distinction in Europe and Japan. BMS’ drug has also now been approved in both the EU and US for NSCLC, giving it a lead over Merck as the two companies go head-to-head in the marketplace.
Keytruda’s earlier entry in the US allowed it to top Opdivo in terms of sales in the first quarter – with the two drugs bringing in $83m and $40m respectively – although BMS may have caught up by the time first-half figures are published later this month.
As a whole the market for these drugs is expected to reach upwards of $15bn in peak annual sales thanks to widespread use across multiple cancer indications, with some analysts predicting twice that amount.