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FDA grants priority review to second-line pembrolizumab for the treatment of R/R Hodgkin lymphoma
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On July 9, 2020, the U.S. Food and Drug Administration (FDA) granted priority review to pembrolizumab as monotherapy for second-line treatment of adult patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL).
Pembrolizumab is an anti-PD-1 humanized monoclonal antibody already approved by FDA for the treatment of pediatric and adult patients with
- cHL who are refractory or who have relapsed after ≥ 3 prior lines of treatment
- R/R primary mediastinal large B-cell lymphoma
It was also approved by the European Medicines Agency (EMA) for the treatment of adult patients with R/R cHL who progressed after receiving autologous stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
The application is based on data from the randomized, open-label, phase III KEYNOTE-204 trial (NCT02684292) comparing pembrolizumab to standard of care BV in patients with R/R cHL. Primary endpoints are progression-free survival and overall survival. Pembrolizumab showed a significant improvement in progression-free survival compared with BV. The study will continue to evaluate the other primary endpoint of overall survival.
The results from this trial were reported at the American Society of Clinical Oncology (ASCO) 2020 Annual Meeting.
- FDA grants priority review to Merck’s supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma. https://www.mrknewsroom.com/newsroom/news-releases/news-details/2020/FDA-Grants-Priority-Review-to-Mercks-Supplemental-Biologics-License-Application-for-KEYTRUDA-pembrolizumab-for-Second-Line-Treatment-of-Patients-With-Relapsed-or-Refractory-Classical-Hodgkin-Lymphoma/default.aspx. Published Jul 09, 2020. Accessed Jul 10, 2020.
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