Drugs

FDA Approves UroGen Bladder Cancer Therapy

FDA has approved a UroGen Pharma NDA for Zusduri (mitomycin intravesical solution) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

Approval was based on data from the ENVISION trial (NCT05243550) that evaluated patients’ complete response (CR) at three months and duration of response (DoR), an FDA release says. CR was defined as no detectable disease in the bladder by cystoscopy and urine cytology. “Among the 223 patients evaluable for response, 78% (95% CI: 72, 83) had a CR,” it says. The DoR ranged from 0 to 25+ months and 79% of responding patients remained in response for at least 12 months.

FDA says the most common adverse reactions (greater than 10%), including laboratory abnormalities, were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils and hematuria. Serious adverse reactions occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%), it adds. A fatal adverse reaction of cardiac failure occurred in one patient.

The approval follows a split vote last month by FDA’s Oncologic Drugs Advisory Committee (4 yes votes to 5 no votes) on whether Zusduri demonstrated a favorable benefit-risk profile (see story). Case Western Reserve Cancer Center oncologist Daniel Spratt voted no and said that without a full randomized trial it was hard to determine mitomycin’s true benefit, adding that there was very limited long-term follow-up.

In voting yes, National Cancer Institute Urologic Oncology Branch associate director Mark Ball acknowledged that a fully enrolled, randomized clinical trial would have mitigated many critiques of mitomycin’s benefit-risk profile. Regardless, he said the company’s data demonstrated both efficacy at three months and that a nonsurgical intervention to treat this disease state was quite encouraging.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome