Saturday, 18 August 2018 - 8:11
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Pembrolizumab

European Commission approves MSD’s Keytruda for Hodgkin Lymphoma

MSD announced that the European Commission approved Keytruda (pembrolizumab) 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, or who are transplant-ineligible. The approved…

FDA accepts two sBLAs for MSD’s Keytruda

MSD announced that FDA has granted Priority Review for two sBLAs (supplemental Biologics License Application) for Keytruda (pembrolizumab), an anti-PD-1 treatment for patients with metastatic or locally advanced urothelial carcinoma. The sBLAs refer to the use of the product as…

MSD’s Keytruda, FDA accepts sBLA with Priority Review for new indication

MSD announced today that FDA accepted a sBLA (supplemental Biologics License Application) for Keytruda (pembrolizumab) for the treatment of previously treated patients with MSI-H cancer (microsatellite instability-high). The PDUFA, with Priority Review, is scheduled for early March 2017 and will…

MSD’s Keytruda meets endpoint and trial stops early

MSD announced that the Phase III KEYNOTE-045 trial, designed to assess Keytruda (pembrolizumab), in patients with previously treated urothelial cancer, has been discontinued early following an independent Data Monitoring Committee evaluation, since the trial met the primary endpoint of overall…

Very positive results for MSD’s Keytruda in NSCLC

MSD announced at the ESMO annual congress the results from Keynote-024, a trial investigating the use of Keytruda (pembrolizumab) vs chemotherapy in patients with NSCLC (non-small cell lung cancer). Keytruda reduced the risk of disease progression or death by 50%…