A Johnson & Johnson cancer treatment that can spare certain bladder cancer patients from the radical step of surgical removal of the organ now has FDA approval. J&J’s drug/device combination product, Inlexzo, came from the 2019 acquisition of Taris Biomedical.
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.
Arbiter’s Anjali Jameson on hospital and payer alignment.
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.
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.
Zelis highlights how employers, payers, and consumers are integrating digital tools to manage healthcare costs.
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.
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.
Artera President Tom McIntyre talks about the practical application of AI in healthcare.
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.
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.