Drugs

Imfinzi Get Expanded Use in High-Risk Bladder Cancer

FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-naïve, high-risk non-muscle invasive bladder cancer, expanding the use of the company’s immunotherapy. The approval covers patients with high-risk non-muscle invasive bladder cancer, or NMIBC, following transurethral resection of a bladder tumor.

The approval was based on results from the Phase 3 POTOMAC trial, which enrolled 1,018 patients with high-risk NMIBC. Eligible patients had at least one high-risk feature, including T1 tumors, high-grade disease, carcinoma in situ or multiple recurrent large tumors, according to an agency release.

The main endpoint was disease-free survival, defined as the time until recurrence of high-risk NMIBC, persistent carcinoma in situ, progression to muscle-invasive or metastatic disease, or death. According to FDA, patients treated with durvalumab plus BCG demonstrated a statistically significant improvement in disease-free survival compared with BCG alone. The combination reduced the risk of recurrence or progression by 32%. Median disease-free survival had not yet been reached in either treatment arm at the time of analysis.

Durvalumab is a programmed death ligand-1, or PD-L1, blocking antibody already approved for several cancer indications, including lung and liver cancers. The prescribing information for Imfinzi includes warnings about immune-mediated adverse reactions, infusion-related reactions, complications following allogeneic hematopoietic stem cell transplantation and embryo-fetal toxicity.

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