Drugs

Priority Review for Orca Blood Cancer Cell Therapy

FDA has accepted for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. The agency has set 4/6/2026 as the user fee review action target date. If approved, Orca-T would become the first allogeneic T-cell immunotherapy available for hematological malignancies, the company says.

The BLA is based on data from the Phase 3 Precision-T trial (NCT04013685), a randomized, open-label, multi-center study comparing Orca-T with conventional allogeneic hematopoietic stem cell transplant. The study met its primary endpoint, showing a statistically significant improvement in survival free of moderate-to-severe chronic graft-versus-host disease among patients treated with Orca-T, according to the company.

Orca Bio says Orca-T is composed of purified regulatory T cells, hematopoietic stem cells, and conventional T cells sourced from matched related or unrelated donors. The therapy is designed to restore healthy immune and blood systems while minimizing transplant-related complications. Orca-T has previously received regenerative medicine advanced therapy and orphan drug designation from FDA for preventing graft-versus-host disease or death in eligible transplant patients.

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