AstraZeneca will voluntarily withdraw the use of the company’s Imfinzi to treat advanced bladder cancer in the United States after the cancer drug failed to meet post-approval requirements, the Anglo-Swedish drugmaker said.
Find out which biopharma companies are raking in the cash this week, as companies from around the globe provide updates on their financing rounds and IPOs.
The U.S. Food and Drug Administration granted expedited approval to UroGen Pharma’s Jelmyto (mitomycin) for pyelocaliceal solution for adults with low-grade upper tract urothelial cancer (LG UTUC) on the basis of data from the Phase III OLYMPUS trial.
AstraZeneca’s treatment options for Stage IV (metastatic) bladder cancer failed to hit the mark of improving overall survival in a Phase III trial.
Oncology is one of the most exciting areas in healthcare, as novel therapies continue to emerge that move forward our molecular understanding of the disease and offer effective treatment advances. This Q&A explores oncology innovation with Kantar’s Stephanie Hawthorne, Vice President of Oncology and Specialty Therapeutics.
The bladder cancer drug Padcev, which was approved by the U.S. Food and Drug Administration in December, secured Breakthrough Therapy designation for the treatment of patients with another type of bladder cancer.
Roche company Genentech announced that the Phase III IMvigor010 trial of Tecentriq as a post-surgery monotherapy did not hit the primary endpoint in muscle-invasive urothelial cancer (MIUC).
The U.S. FDA approved Merck & Co. Inc.’s Keytruda for a hard-to-treat form of bladder cancer, making the blockbuster therapy the first new treatment for the cancer in more than two decades.
The U.S. Food and Drug Administration approved Astellas Pharma Inc. and Seattle Genetics Inc.’s experimental drug Padcev to treat advanced bladder cancer, about three months ahead of schedule.
The Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration voted 9-4 in favor of recommending Merck’s anti-PD-1 therapy Keytruda for the treatment of certain patients with high-risk, non-muscle invasive bladder cancer.