Biologics

Janssen sBLA for Darzalex FasPro for Amyloidosis

Janssen Pharmaceutical Companies has submitted a supplemental BLA for Darzalex FasPro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for treating patients with light chain amyloidosis, a life-threatening disorder that occurs when plasma cells in bone marrow produce abnormal light chains that form amyloid deposits, which build up in vital organs and eventually cause organ deterioration. The submission is being reviewed under FDA’s Real-Time Oncology Review program, which allows data for certain applications to be reviewed before the applicant formally submits the complete application. It is also being reviewed under Project Orbis, an FDA Oncology Center of Excellence program that provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies, Janssen says.

The supplemental BLA is supported by data from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the European Hematology Association Annual Congress in June. “ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate,” the company says.

FDA had originally granted accelerated approval for Darzalex in 2015 to treat patients with multiple myeloma who have received at least three prior treatments.

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