Johnson & Johnson’s Balversa therapy finally gets full FDA approval
The approval by the Federal Drug Agency of the bladder cancer therapy Balversa has taken a notch higher the search for more treatment options.
March 5, 2024
by Shem Oirere
US clears BMS' Opdivo as first adjuvant therapy for bladder cancer
Bristol Myers Squibb said Friday that the FDA has expanded Opdivo's (nivolumab) urothelial carcinoma (UC) indication to include adjuvant use in high-risk patients, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
August 23, 2021
by firstwordpharma
SMC approves Bavencio for bladder cancer
Merck and Pfizer’s Bavencio (avelumab) has been approved by the Scottish Medicines Consortium (SMC) for use via NHS Scotland as a first-line maintenance treatment for adult patients with locally advanced or metastatic urothelial carcinoma ...
August 11, 2021
by pharmatimes
Nonacus partners with Birmingham University to develop bladder cancer test
Genetic testing company Nonacus has partnered with the University of Birmingham to develop a non-invasive, urine test for bladder cancer.
July 2, 2021
by pharmatimes
Gilead’s Trodelvy scores accelerated approval in advanced bladder cancer
Gilead’s antibody drug conjugate (ADC) Trodelvy has received an accelerated approval from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial cancer (UC), the most common form of bladder cancer.
April 15, 2021
by pharmatimes
Roche to withdraw US indication for Tecentriq in bladder cancer
Roche is set to voluntarily withdraw the US indication for Tecentriq (atezolizumab) in prior platinum treated metastatic urothelial carcinoma (mUC, bladder cancer) following its consultation with the US Food and Drug Administration (FDA).
March 10, 2021
by pharmaceutical-technolog
AZ withdraws Imfinzi indication in the US for advanced bladder cancer
AstraZeneca (AZ) has announced the voluntary withdrawal of its immunotherapy Imfinzi in its advanced bladder cancer indication in the US.
February 23, 2021
by pharmatimes
LIPAC Oncology Announces Completion of LiPax Trial for Bladder Cancer
LIPAC Oncology announced the successful completion of a Phase 2A marker lesion clinical trial designed to predict long-term (two-year) recurrence free survival rates in patients with low-grade highly recurrent Non-Muscle Invasive Bladder Cancer (NMIBC)...
September 24, 2020
by americanpharmaceuticalreview
Avelumab significantly improves advanced bladder cancer patient survival
A Phase III trial concluded that avelumab is an effective maintenance therapy for patients with advanced or metastatic urothelial carcinoma, whose disease had not progressed after chemotherapy.
September 22, 2020
by europeanpharmaceuticalreview
UK bladder cancer patients get early access to Bavencio
Merck and Pfizer’s Bavencio (avelumab) is now available under the UK's Early Access to Medicines Scheme (EAMS) giving some patients with bladder cancer the chance to receive treatment with the immunotherapy before its approval in Europe.
September 4, 2020
by pharmatimes
Imfinzi Granted FDA Priority Review for Less-Frequent, Fixed-Dose Use
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 ...
August 21, 2020
by americanpharmaceuticalreview
Priority review for Imfinzi's less-frequent dosing regimen
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.
August 19, 2020
by pharmatimes