Drugs

J&J Complete Response Letter on Darzalex Faspro

FDA has issued Johnson & Johnson a complete response letter (CRL) for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in a quadruplet regimen in patients with newly diagnosed, transplant-ineligible multiple myeloma. The CRL is based on observations from facility inspections and is not related to any safety and efficacy data submitted in the application, according to the company. No new clinical studies were requested.

The company says Darzalex Faspro remains fully approved and commercially available for all nine of its existing U.S. indications in multiple myeloma, and the company emphasized that global supply and distribution are unaffected. The rejected application sought approval for use in a quadruplet regimen with bortezomib, lenalidomide, and dexamethasone, based on data from the Phase 3 CEPHEUS trial. It notes that the same indication was recently approved by the European Commission, and regulatory submissions in other international markets are ongoing.

The Phase 3 CEPHEUS study demonstrated that patients receiving the Darzalex Faspro-based regimen showed statistically significant improvements in minimal residual disease (MRD) negativity, progression-free survival, and complete response rates compared to standard therapy, J&J says. The study results were presented at the 2024 International Myeloma Society’s annual meeting and published in Nature Medicine.

Darzalex Faspro is the subcutaneous version of daratumumab, co-formulated with Halozyme’s ENHANZE delivery technology. It was first approved in the U.S. in 2020 and is currently authorized for nine indications, including frontline treatment for newly diagnosed multiple myeloma patients who are either transplant-eligible or ineligible.

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