Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.
Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
Merck & Co. is driving forward in its quest to develop a premier immuno-oncology pipeline with the acquisition of Australia-based Viralytics Ltd. and its oncolytic immunotherapy treatments.
Merck & Co.’s Keytruda came up short in a pivotal study as a second-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma.
Merck announced that the company pulled its application for Keytruda (pembrolizumab) in combination with pemetrexed and carboplatin as a first-line treatment for metastatic nonsquamous non-small cell lung cancer from the European Medicines Agency.
Seattle Genetics and Takeda Pharmaceutical Company announced positive results from the Phase III ECHELON-1 clinical trial in previously untreated advanced classical Hodgkin lymphoma.
Six months after touting positive data from a Phase I/II combination study of Opdivo and Adcetris in patients with relapsed or refractory classical Hodgkin lymphoma at the American Society of Hematology, Bristol-Myers Squibb and Seattle Genetics are plowing forward into a Phase III trial.