Merck Sharp and Dohme (MSD) has announced that its cancer drug Keytruda has received approval in a new Hodgkin lymphoma indication by the European Commission (EC).
The anti-PD-1 therapy has been ratified for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible.
The EC’s decision was based on clinical data drawn from 241 patients involved in the KEYNOTE-087 and KEYNOTE-013 trials, which demonstrated the effectiveness of Keytruda in treating patients who did not respond to other forms of therapy.
The safety analysis supporting the EC approval of the drug was based on data from 3194 patients with advanced melanoma, non-small cell lung cancer or classical Hodgkin lymphoma across four doses.
Earlier this year, Keytruda was approved as a treatment for metastatic non-small cell lung cancer patients whose tumours have high PD-L1 expression, with no EGFR or ALK-positive tumour mutations.