Drugs

FDA Questions Zynlonta’s Benefit/Risk: Report

ADC Therapeutics says that at a recent meeting with FDA, agency officials indicated that they have “substantial concerns regarding the benefit/risk or verification of clinical benefit” in the LOTIS-5 trial of the company’s Zynlonta (loncastuximab tesirine) to treat diffuse large B-cell lymphoma (DLBCL). In an online report, Pharmaphorum says company officials said they were “assessing the best regulatory path forward” for Zynlonta and the LOTIS-5 data as a result of the meeting.

The newsletter reports that ADC also is investigating a combination of Zynlonta and Roche’s Columvi (glofitamab) as a second-line or later regimen in DLBCL.

Pharmaphorum says questions were raised in June when a company update showed that 13.2% of patients treated with Zynlonta in LOTIS-5 died, compared to 4.6% of the control arm. The company told investors that FDA was concerned about the imbalance in Grade 5 events, when assessed in the context of a marginal treatment benefit.

The report says Zynlonta was granted accelerated approval by FDA as a third-line or later treatment for DLBCL. The company intended LOTIS-5 to convert the accelerated approval to a full approval and move the drug into a second-line setting.

While Zynlonta and rituximab (Genentech/Biogen’s Rituxan) improved progression-free survival by 27% compared to Rituxan plus chemotherapy, Pharmaphorum says, there was no benefit on overall survival. “Add in the imbalance in deaths between the groups, and ADC’s plans for the drug seem speculative at best,” it says.

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