Biologics

FDA OKs Darzalex Faspro for Smoldering Multiple Myeloma

FDA has approved Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj, Janssen Biotech) for adults with high-risk smoldering multiple myeloma (SMM), marking the first approved therapy for this early stage of the blood cancer. The decision is based on data from the Phase 3 AQUILA trial (NCT03301220), which compared Darzalex Faspro monotherapy to active monitoring in 390 patients with high-risk SMM. The study showed a 51% reduction in the risk of progression or death compared with patients under observation alone, an agency release says.

FDA says that high-risk SMM is defined by certain biological markers — such as serum monoclonal protein levels above 2 g/dL, a free light chain ratio greater than 20, or bone marrow plasma cells exceeding 20%. About 41% of participants in AQUILA met two or more of these criteria.

Darzalex Faspro combines the CD38-directed antibody daratumumab with hyaluronidase, an enzyme that enables rapid subcutaneous administration. As with other anti-CD38 therapies, Darzalex Faspro can interfere with blood typing and cross-matching tests.

Darzalex Faspro is already approved for several multiple myeloma indications, including newly diagnosed and relapsed or refractory disease, but this new indication extends its reach into pre-symptomatic, high-risk patients, aiming to delay full disease onset, according to the company.

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