Biologics

Celgene BLA for Abecma OK’d for Multiple Myeloma

FDA has approved a Celgene BLA for Abecma (idecabtagene vicleucel), a cell-based gene therapy for treating adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines of therapy. The agency says this is the first cell-based gene therapy approved for treating multiple myeloma.

FDA describes Abecma as a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose of Abecma is a customized treatment created by using a patient’s own T-cells, which are “genetically modified to include a new gene that facilitates targeting and killing myeloma cells,” it says. Once the cells are modified, they are infused back into the patient.

Approval was based on data from a multicenter study of 127 patients with relapsed myeloma and refractory myeloma, who had received at least three prior antimyeloma lines of therapy. “About 88% of patients in the study group had received four or more prior lines of antimyeloma therapy,” the agency says. “Overall, 72% of patients partially or completely responded to the treatment. Of those studied, 28% of patients showed complete response — or disappearance of all signs of multiple myeloma — to Abecma, and 65% of this group remained in complete response to the treatment for at least 12 months.”

On the safety side, FDA says Abecma’s label carries a Boxed Warning for cytokine release syndrome (CRS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome, neurologic toxicity, and prolonged cytopenia, all of which can be fatal or life-threatening. “Because of the risk of CRS and neurologic toxicities, Abecma is being approved with a risk evaluation and mitigation strategy which includes elements to assure safe use,” it says. “The FDA is requiring that hospitals and their associated clinics that dispense Abecma be specially certified and staff involved in the prescribing, dispensing or administering of Abecma are trained to recognize and manage CRS and nervous system toxicities and other side effects of Abecma."

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

Read more

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