Drugs

Imfinzi Wins Approval for Bladder Cancer

FDA has approved AstraZeneca’s Imfinzi (durvalumab) for treating adults with muscle invasive bladder cancer (MIBC). The approval covers Imfinzi’s combination use with gemcitabine and cisplatin as a neoadjuvant therapy, followed by durvalumab as an adjuvant monotherapy after radical cystectomy.

The approval is based on the results of the NIAGARA trial (NCT03732677), a Phase 3 study that enrolled 1,063 patients eligible for radical cystectomy who had not received prior systemic therapy for bladder cancer, according to an FDA release. The study’s primary efficacy endpoint was event-free survival, with overall survival as an additional measure. The data showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death vs. neoadjuvant chemotherapy alone, AstraZeneca says.

The safety profile of durvalumab was consistent with prior findings for the drug in combination with platinum-based chemotherapy, FDA notes.

The human monoclonal antibody works by binding to the PD-L1 protein and blocking the interaction of PD-L1 with the PD-1 and CD80 proteins, “countering the tumor's immune-evading tactics and releasing the inhibition of immune responses,” the company says. It is currently approved for treating unresectable, Stage III non-small cell lung cancer in patients whose disease has not progressed after chemoradiotherapy. It is also approved for treating locally advanced or metastatic biliary tract cancer, resectable gastric and gastroesophageal junction cancers, and endometrial cancer.

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