Drugs

Janssen sBLA for Darzalex Combo Myeloma Treatment

Janssen Pharmaceutical has submitted a supplemental BLA for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The submission, which is based on data from the Phase 3 MAIA (MMY3008) clinical study, is being reviewed by the agency under its Real-Time Oncology Review pilot program. This allows FDA to review data before the applicant formally submits the complete application. It aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients.

Data submitted show that at a median follow-up of 28 months, the combination therapy reduced the risk of disease progression or death by 44% compared to treatment with lenalidomide and dexamethasone alone. The addition of Darzalex resulted in “deeper responses” compared to lenalidomide and dexamethasone alone, including increased rates of complete response or better, Janssen says.

The most common treatment-emergent severe adverse events for the combination therpy included neutropenia (50%), lymphopenia (15%), pneumonia (14%) and anemia (12%), the company says.

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