Drugs

FDA Lifts Clinical Holds on Aprea Trials

FDA has lifted clinical holds on Aprea Therapeutics’ clinical trials involving eprenetapopt in combination with azacitidine in myeloid malignancy programs. In 8/2021, FDA placed holds on the company’s Phase 3 frontline Myelodysplastic Syndrome (MDS) clinical trial, a Phase 2 MDS/acute myeloid leukemia post-transplant clinical trial, and a Phase 1/2 AML clinical trial.

Aprea says that in 12/2021 it discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and reached agreement on proposals for new clinical trials in myeloid malignancies. “In the first quarter of 2022 the company received clearance from FDA to proceed under its existing myeloid malignancy IND with a new clinical trial in relapsed/refractory MDS and AML,” it says.

At the time the clinical holds were first announced, the company said there were about 20 patients then receiving eprenetapopt in combination with azacitidine in its myeloid malignancy programs, which included the MDS, AML and post-transplant maintenance trials, all of which have completed enrollment. It said patients who are benefiting from treatment could continue to receive study treatment, but no new patients should be enrolled until the hold was resolved.

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