Drugs

FDA Approves Karyopharm sNDA for Xpovio

FDA has approved a Karyopharm Therapeutics supplemental NDA for Xpovio (selinexor), a selective inhibitor of nuclear export compound for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It was approved under FDA’s accelerated approval program. The drug first gained accelerated approval 7/2019 in combination with dexamethasone for treating adult patients with relapsed refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Karyopharm says the new indication was approved based on the results from the multi-center, single-arm Phase 2b SADAL study (NCT02227251), which evaluated 134 patients with relapsed or refractory DLBCL. The study met its primary endpoint with an overall response rate of 29%, including 18 (13%) complete responses and 21 (16%) partial responses. The most common treatment-related adverse events were cytopenias along with gastrointestinal and constitutional symptoms and were generally reversible and managed with dose modifications or standard supportive care.

As part of the accelerated approval, FDA agreed that the XPORT-DLBCL-030 study could serve as a confirmatory trial for evaluating selinexor in DLBCL. This trial will assess the effect of selinexor or placebo added to a standard backbone immunochemotherapy of rituximab-gemcitabine-dexamethasone-platinum (R-GDP) in patients with one to three prior treatments for DLBCL.

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