Gilead Sciences reported Trodelvy’s Phase 3 test in metastatic urothelial cancer fell short of showing a statistically significant benefit on the overall survival main goal. The antibody drug conjugate had received accelerated FDA approval for this type of cancer in 2021.
ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells.
At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.
CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments.
CG Oncology’s main asset is cretostimogene, an oncolytic virus in late-stage development as a treatment for advanced bladder cancer. The IPO filing follows the report of interim efficacy data showing a 75% complete response rate.
A Ferring Pharmaceuticals gene therapy is now FDA approved for treating bladder cancer that does not respond to an immunotherapy used to treat the cancer in its early stages. The Ferring gene therapy, Adstiladrin, turns bladder wall cells into tiny factories churning out a cancer-fighting therapeutic protein.
Tecentriq failed to beat chemotherapy in improving overall survival, the main goal of its confirmatory Phase 3 test in bladder cancer. The drug had been granted accelerated approval based on results from a single-arm Phase 2 clinical trial.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
Bristol Myers Squibb and Nektar Therapeutics are ending a cancer drug research alliance after data showed the combination of their respective drugs failed clinical trials in kidney and bladder cancers. The disappointing results come one month after the drug combo failed a pivotal melanoma clinical trial.
For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.
Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on the market. The voluntary withdrawal comes amid an industry-wide FDA review of drugs that were awarded accelerated approval but later failed confirmatory studies.
The FDA approved Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate for locally advanced or metastatic urothelial carcinoma, which marks the Seattle biotech's second regulatory approval.
This eBook, in collaboration with Care Logistics, details how hospitals and health systems can facilitate more effective decision-making by operationalizing elevated awareness.
The company's lead product candidate, CG0070, has completed a Phase II study and will be tested in another trial, combined with Merck's Keytruda.
Both Roche and AstraZeneca have been caught off guard with Phase 3 data readouts that failed to meet their respective primary endpoints.
After selling its lead product to Allergan last year for $587.5 million, TARIS Biomedical has pivoted into developing a bladder cancer drug device combination with a $32 million investment.
It has three platforms: A soluble T-cell antigen receptor that zeroes in on cancerous or viral targets; a monoclonal antibody approach using tissue factor antagonists; and an IL-15 platform that's meant to harness IL-15 super-agonists, antagonists and protein scaffolds to build novel immune molecules.
Cold Genesys, a sort of latter-day spinoff of the once-promising cancer vaccine maker Cell Genesys, has an engineered oncolytic virus that shows promise in treating a dangerous form of bladder cancer. The Newport Beach, California company just received $13.6 million from Hong Kong-based investment fund Ally Bridge Group. It has rejiggered an adenovirus that typically causes […]