Drugs

Positive Results for Tecvayli/Darzalex Faspro Combo

Johnson & Johnson says initial results from the Phase 3 MajesTEC-3 study of the combination of Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) showed the combination significantly improved progression-free survival and overall survival versus standard of care in relapsed/refractory multiple myeloma. A company statement says the independent data monitoring committee has recommended unblinding the study based on the statistically significant results.

Tecvayli is described as a first-in-class bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. It was approved by FDA in 10/2022 as an off-the-shelf antibody that is administered as a subcutaneous treatment for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

Darzalex Faspro was approved in 5/2020 and is now approved for 10 indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. Darzalex itself was approved in 11/2015 as the first CD38-directed antibody approved to treat multiple myeloma.

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