Drugs

Panel is Split on UroGen’s Bladder Cancer Drug

FDA’s Oncologic Drugs Advisory Committee 5/21 was split (4 yes votes to 5 no votes) in its voting on whether UroGen Pharma’s NDA for mitomycin intravesical solution demonstrated a favorable benefit-risk profile for treating adult patients with low-grade intermediate-risk non-muscle invasive bladder cancer. Case Western Reserve Cancer Center oncologist Daniel Spratt voted no and said that without a full randomized trial it is 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 efficacy at three months, and that a nonsurgical intervention to treat this disease state and that the signal at 12 months and beyond, even though there are differences in the interpretation of the data, 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