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Home Industry News Merck Sharp and Dohme’s Keytruda receives Hodgkin lymphoma approval in Europe

Merck Sharp and Dohme’s Keytruda receives Hodgkin lymphoma approval in Europe

9th May 2017

Merck Sharp and Dohme has announced that its cancer drug has been approved in a new Hodgkin lymphoma indication by the European Commission.

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.

This decision was based on clinical data drawn from 241 patients involved in the KEYNOTE-087 and KEYNOTE-013 trials, showing the effectiveness of the drug in treating patients who were not able to respond to other forms of therapy.

Meanwhile, the safety analysis supporting the European approval of Keytruda was based on data from 3,194 patients with advanced melanoma, non-small cell lung cancer or classical Hodgkin lymphoma across four doses.

Dr Roger Dansey, senior vice-president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said: "Today's approval brings an important new treatment option to patients in Europe with classical Hodgkin lymphoma who have not responded to existing therapies."

This comes after the drug was approved earlier this year 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.

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