Drugs

FDA OKs Blood Cancer Drug Tregzi

FDA has approved Orca Biosystems’ Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) suspension, for intravenous infusion, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers undergoing allogeneic hematopoietic stem cell transplantation. An FDA notice says Tregzi is a novel approach to allogeneic hematopoietic stem cell transplantation in some adults with high-risk blood cancers. It says it addresses an important unmet need in transplantation, where curing the cancer is often only part of the challenge; avoiding chronic GVHD is equally important for long-term outcomes.

The notice says Tregzi uses stem cells and immune cells collected from blood of a closely matched donor to help the body fight cancer while reducing the risk of GVHD, which can occur when transplanted donor blood cells attack the patient’s body. Patients receive the treatment after undergoing chemotherapy to prepare their bodies for a bone marrow or stem cell transplant, FDA says.

Tregzi’s safety and effectiveness were established through the PRECISION-T trial in which 187 adult patients with blood cancers were randomly assigned to receive either Tregzi or a standard stem cell transplant. FDA says the primary endpoint was chronic GVHD-free survival. It says that at one year, 78% of patients who received Tregzi achieved the outcome, compared to 38.4% of patients who received a standard transplant.

The Tregzi side effects were most commonly infections. The notice says no patient had a severe reaction during the Tregzi infusion and no cases of graft failure were observed within the study period.

The agency granted the Tregzi application orphan drug and regenerative medicine advanced therapy designations.

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