Drugs

Trial Results Unlikely to Support sNDA Approval: FDA

Karyopharm Therapeutics says that during a recent meeting with FDA officials, the officials expressed doubt that the results of the SIENDO trial would support approval of an sNDA for the company’s selinexor (Xpovio) as front-line maintenance therapy following chemotherapy in patients with advanced or recurrent endometrial cancer. “Karyopharm and the FDA participants had differing views on the study significance and overall clinical benefit for the whole population and discussed that further exploration of patients with advanced or recurrent endometrial cancer with p53 wild-type is warranted,” the company says. “The company will continue to collect and analyze the SIENDO study data and work with FDA to explore all regulatory pathways for patients with p53 wild-type.”

Karyopharm also says it will start a new study of selinexor in patients with p53 wild-type endometrial cancer.

Xpovio is described as a first-in-class, oral exportin 1 (XPO1) inhibitor. It is the first of Karyopharm’s Selective Inhibitor of Nuclear Export compounds to be approved to treat cancer. It functions by selectively binding to and inhibiting the nuclear export protein XPO1 and is approved in the U.S. for multiple oncology indications.

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