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Imfinzi Granted FDA Priority Review for Less-Frequent, Fixed-Dose Use americanpharmaceuticalreview
August 21, 2020
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications ...
Priority review for Imfinzi's less-frequent dosing regimen pharmatimes
August 19, 2020
AstraZeneca's Imfinzi (durvalumab) has been granted a priority review in the US for a new four-week, fixed-dose regimen for treatment of non-small cell lung cancer (NSCLC) and bladder cancer.
US approves Bavencio for bladder cancer pharmatimes
July 02, 2020
EMD Serono, the biopharmaceutical business of Merck KGaA, and Pfizer announced that the US Food and Drug Administration (FDA) has expanded use of Bavencio (avelumab) to include maintenance treatment of patients ...
MSD's Keytruda misses advanced bladder cancer goal pharmatimes
June 16, 2020
MSD's Keytruda (pembrolizumab) has failed to hit key goals in a trial assessing its potential as a first-line treatment for bladder cancer.
Study reveals immunotherapy after chemotherapy slows metastatic bladder cancer expresspharma
April 13, 2020
The randomised Phase 2 trial tested immunotherapy known as pembrolizumab in 108 patients after they were treated with platinum-based chemotherapy.
Imfinzi cancer combo falls short in DANUBE trial pharmatimes
March 09, 2020
AstraZeneca has released an update from its Phase III DANUBE trial, assessing Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer.
FDA approves Keytruda for patients with high-risk, non-muscle invasive bladder cancer europeanpharmaceuticalreview
January 14, 2020
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.
FDA Approves Pembrolizumab for Bladder Cancer americanpharmaceuticalreview
January 09, 2020
The Food and Drug Administration (FDA) approved pembrolizumab (KEYTRUDA, Merck) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk ...
FDA Approves New Drug, PADCEV to Treat Locally Advanced or Metastatic Urothelial Cancer Lin Zhang
January 03, 2020
A new drug, PADCEV (enfortumab vedotin-ejfv) to treat patients with locally advanced or metastatic urothelial cancer, was approved under the FDA’s Accelerated Approval Program based on tumor response rate.
FDA approves Astellas-Seattle Genetics’ bladder cancer drug pharmaceutical-technology
December 23, 2019
The US Food and Drug Administration (FDA) has granted accelerated approval to Astellas Pharma and Seattle Genetics’ Padcev drug to treat locally advanced or metastatic urothelial cancer.

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