MSD’s anti-PD-1 therapy Keytruda has taken a giant leap towards being approved in Europe for the treatment of classical Hodgkin Lymphoma (cHL).
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed expanding the list of approved uses for the drug to include relapsed or refractory cHL in adults who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
The positive opinion was based on data from the KEYNOTE-087 and KEYNOTE-013 trials, which included patients regardless of PD-L1 expression and demonstrated significant response and remission rates.
The 210-patient Keynote-087 trial showed an overall response rate with Keytruda (pembrolizumab) of 69 percent with a complete remission rate of 22 percent and a partial remission rate of 47 percent. Also, among the 145 responding patients, the median duration of response was 11.1 months.
The drug is already approved in Europe across lung cancer and melanoma indications; a decision on its use in cHL is expected in the second quarter of 2017.
Earlier this month, Keytruda became the first anti-PD1 therapy to be approved in a blood cancer after regulators issued a green light for its use in cHL.