Drugs

FDA Lifts Hold on Ryvu Myeloid Leukemia Trial

FDA has lifted a partial clinical hold against Ryvu Therapeutics and its Phase 1b dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. The hold was issued after Ryvu reported a patient death that might have been related to RVU120. Study protocol modification have been made to FDA’s satisfaction, the company says.

“Based on the recommendations from the FDA, the study will resume enrollment at a 75mg dose (Every Other Day – EOD) in a standard 3+3 design, according to a revised protocol intended to increase patients’ safety,” according to Ryvu. The protocol amendment covers modified exclusion criteria, scope of monitoring and frequency of laboratory testing, it says. Following the completion of the 75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established. Additionally, Ryvu plans to use 75mg as the starting dose for a single-agent, open-label Phase 1/2 trial investigating the safety and efficacy of RVU120 in patients with relapsed/refractory metastatic or advanced solid tumors, which will begin patient enrollment this quarter.

Ryvu describes RVU120 as a selective first-in-class CDK8/CDK19 inhibitor which has demonstrated efficacy in a number of solid tumor types in in vitro and in vivo models, as well as in onco-hematological malignancies.

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