Drugs

Carvykti Shows Favorable Minimal Residual Disease Data

Johnson & Johnson says data from its Phase 3 CARTITUDE-4 study show a single infusion of Carvykti (ciltacabtagene autoleucel; cilta-cel) significantly increased minimal residual disease (MRD) negativity rates in patients with relapsed or refractory multiple myeloma who were lenalidomide-refractory and had received one to three prior lines of therapy compared to standard therapies.

The company says MRD is a prognostic marker of increased survival outcomes in multiple myeloma patients. “These results add to the overall survival (OS) benefits recently presented at the International Myeloma Society meeting earlier this year, as the first and only cell therapy to significantly extend OS versus standard therapies for patients with multiple myeloma,” it says.

In the study, a 34-month follow-up showed MRD-negativity rates for evaluable patients that were more than double in those treated with Carvykti versus standard therapies (89% vs. 38%), according to the company. “At 2.5 years, sustained (12 months or more) MRD-negative complete response or better in evaluable patients treated with Carvykti was five-fold higher than that of standard therapies…” it adds.

FDA approved Carvykti in 2/2022 to treat adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy. In April, it was approved to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy and who are refractory to lenalidomide, following an FDA Oncologic Drugs Advisory Committee 11-0 vote in favor of the new indication.

Carvykti is described as a BCMA-directed, genetically modified, autologous T-cell one-time infusion immunotherapy that involves reprogramming a patient’s T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T-cells to eliminate cells that express BCMA.

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