Expanded indication for Keytruda approved in Europe

The European Commission has approved Keytruda (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL)who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

The drug is already marketed by US pharma giant Merck & Co (NYSE: MRK) for a number of cancer indications and generated first-quarter sales of $584 million in the first quarter of this year. Keytruda was approved for classic Hodgkin lymphoma by the US Food and Drug Administration in March this year.Another PD inhibitor, Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), is also already approved for this indication in both Europe and the USA.

The EC approval allows marketing of Keytruda in all 28 European Union member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200mg every three weeks until disease progression or unacceptable toxicity.