Drugs

Karyopharm sNDA Filed for Xpovio in Myelofibrosis

Karyopharm Therapeutics has submitted a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitinib for patients with myelofibrosis. Karyopharm has requested a priority review, which, if granted, could result in a six-month review.

The sNDA is based, in part, on data from the Phase 3 SENTRY trial that the company believes supports a positive benefit-risk profile for the combination, including a promising signal of overall survival. The company expects that approval under the accelerated approval pathway would require FDA to “agree that spleen volume reduction greater than 35% (SVR35) is a reasonably likely surrogate endpoint to predict overall survival.” It plans to use long-term overall survival data from the SENTRY trial to verify clinical benefit and support conversion from accelerated to traditional approval.

Xpovio is described as a first-in-class, oral exportin 1 (XPO1) inhibitor compound for treating cancer. It works by selectively binding to and inhibiting the nuclear export protein XPO1. The drug is approved in multiple oncology indications, including: (1) in combination with Velcade (bortezomib) and dexamethasone in adult patients with multiple myeloma after at least one prior therapy; and (2) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma.

A previous accelerated approval for diffuse large B-cell lymphoma was officially withdrawn in April after the company failed to complete a confirmatory study.

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

Read more

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