Drugs

Teclistamab Cuts Myeloma Risk of Progression by 71%: J&J

Johnson & Johnson is reporting positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli (teclistamab-cqyv) significantly improved survival outcomes compared with standard treatments in patients with relapsed or refractory multiple myeloma, including those who had failed commonly used therapies.

The Phase 3 MajesTEC-9 study found that Tecvayli monotherapy reduced the risk of disease progression or death by 71% and lowered the risk of death by 40% versus standard-of-care regimens in patients who were predominantly refractory to anti-CD38 antibodies and lenalidomide (Bristol Myers Squibb's Revlimid), the company says. The results demonstrate superior progression-free survival and overall survival as early as second-line treatment, positioning the therapy as a potential new standard of care earlier in the disease course, it notes.

The study builds on earlier Phase 3 data from MajesTEC-3, which showed survival benefits for Tecvayli in combination with J&J's Darzalex Faspro (daratumumab and hyaluronidase-fihj) in patients who were naïve or sensitive to anti-CD38 therapy. Together, the two trials address different segments of relapsed disease and reinforce the drug’s role across a broad patient population, the company says.

Tecvayli, a first-in-class bispecific T-cell engager targeting BCMA on myeloma cells and CD3 on T cells, received accelerated approval from FDA in 2022 for heavily pretreated multiple myeloma. Multiple myeloma, a blood cancer marked by frequent relapse, remains difficult to treat once patients stop responding to frontline therapies. While treatment options have expanded in recent years, outcomes for patients who become refractory to anti-CD38 antibodies and lenalidomide remain poor, creating a high unmet medical need.

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