Drugs

FDA Awards Priority Voucher for Multiple Myeloma Combo

FDA has proactively awarded Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating relapsed or refractory multiple myeloma, citing strong late-stage clinical trial results. The award brings the total number of products selected under the Commissioner’s National Priority Voucher pilot program to 16. According to FDA, the decision followed the release of Phase 3 trial data showing the teclistamab–daratumumab regimen, known as Tec-Dara, significantly outperformed standard of care in both progression-free survival and overall survival in patients who had received one to three prior lines of therapy. At three years, more than 80% of patients treated with the combination remained progression-free. Those results were first disclosed 11/24 in materials released ahead of the American Society of Hematology (ASH) annual meeting and were subsequently published in the New England Journal of Medicine 12/9.

FDA commissioner Marty Makary says in a news release that the agency acted quickly after reviewing the data. Within hours of the trial results appearing in the ASH conference program, FDA leadership reviewed the findings and consulted internal experts, he says, before contacting the sponsor the following day to discuss awarding a priority voucher. “When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly,” Makary adds, describing the agency’s approach as proactive rather than reactive.

The voucher program is designed to speed development and review of therapies that address pressing public health needs or demonstrate the potential for substantial clinical impact. It is also not without controversy. Retiring CDER director Richard Pazdur reportedly had questions about the pilot program because it may be unlawful and could jeopardize patient safety. Internally, Pazdur had warned that the program’s framework may conflict with long-standing statutory requirements governing drug approvals. Previous Center director George Tidmarsh had similarly warned that the initiative could upend decades of regulatory precedent.

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