Drugs

AstraZenenca Withdraws Imfinzi Bladder Cancer Use

AstraZeneca has withdrawn an Imfinzi (durvalumab) indication, treating previously treated adult patients with locally advanced or metastatic bladder cancer, after confirmatory data did not support the indication, which was granted accelerated approval 5/2017. The withdrawal does not impact the indication outside the U.S., and does not affect other approved Imfinzi indications within or outside the U.S., the company says.

AstraZeneca says that continued approval of the locally advanced or metastatic bladder cancer indication was contingent on results from the DANUBE Phase 3 trial in first-line metastatic bladder cancer setting, which did not meet its primary endpoints last year. It added that FDA was consulted in the indication’s withdrawal.

Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering a tumor’s immune-evading response and releasing the inhibition of immune responses. It is currently approved for treating unresectable, Stage 3 non-small cell lung cancer after chemoradiation therapy. It is also approved for treating extensive stage small cell lung cancer. The therapy is also being tested as a monotherapy and in combination use as a treatment for patients with bladder cancer, liver cancer, biliary tract cancer, oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumors, according to the company.

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