Drugs

Acrivon Gets 2 Fast Track Designations for Prexasertib

FDA has granted Acrivon Therapeutics two fast track designations for developing ACR-368 (prexasertib) in platinum-resistant ovarian cancer and endometrial cancer. The targeted DNA damage response inhibitor therapy is being studied in a multicenter, open-label, single arm Phase 2 clinical trial in patients with platinum-resistant ovarian cancer, endometrial adenocarcinoma, and urothelial cancers based on OncoSignature-predicted sensitivity to ACR-368, the company says. Acrivon has obtained exclusive rights to develop and commercialize ACR-368 under a license agreement with Eli Lilly.

The companion diagnostic OncoSignature uses proteomic biomarkers to identify the patients most likely to benefit from a drug candidate, Acrivon says. “We have shown that the ACR-368 OncoSignature test was able to predict drug responders in blinded, prospectively designed studies on pretreatment tumor biopsies collected from past clinical trials and in patient derived xenograft studie,” it adds.

Acrivon also says ACR-368 has shown “deep, durable single-agent activity, including complete responses, in a proportion of patients across several Phase 2 studies, including platinum-resistant ovarian cancer, squamous cell cancer of the head and neck, as well as anal cancer for which Orphan Drug Designation has been granted.”

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