The FDA has approved a Bristol Myers Squibb cell therapy made by engineering a patient’s immune cells to target a cancer protein called BCMA. The regulatory decision for Abecma in multiple myeloma gives BMS its second approved CAR-T therapy.
The companies said Tuesday that the FDA had accepted their application for idecabtagene vicleucel, which they resubmitted in July after the agency initially refused to file it in May. The action date is in March of next year.
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Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.
The companies' resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.
The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.
The FDA's Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug's first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.
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The patient, who had been enrolled in the Phase I study at the higher dose level of UCARTCS1A, suffered a cardiac arrest, the causes of which are under investigation, the company said.
The drug, belantamab mafodotin, could become the first approved therapy for multiple myeloma that targets the cell-surface antigen BCMA. The FDA accepted the application for the drug in January.
Johnson & Johnson, which in-licensed Legend's CAR-T technology and is developing a version of its product under the name JNJ-4528, presented data from the Phase Ib/II CARTITUDE-1 study at the ASCO meeting.
Data for the drug, CC-92480, showed an overall response rate of more than 54% when given at the recommended Phase II dose in 11 heavily pretreated patients. The drug is part of a new class known as CELMoD agents.
At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.
In a presentation of data at ASCO on the Phase I/II study of orvacabtagene autoleucel in patients with heavily pretreated multiple myeloma, it was stated that the study added a new cohort of patients with prior exposure to therapies that, like orva-cel, target the BCMA antigen.
The company said the DREAMM-2 study of belantamab mafodotin, its antibody-drug conjugate that targets BCMA, showed a median overall survival of nealry 15 months in heavily pretreated patients.
The company will present data from the Phase I trial of teclistamab in an oral session at the ASCO virtual meeting later this month. The drug, a bispecific monoclonal antibody against the antigen BCMA, is a potential competitor to a similar therapy developed by Amgen.
Data on the CAR-T, JNJ-4528, will be presented at the ASCO virtual meeting. In an interview, a J&J executive talked about how the therapy could be developed for outpatient use through patient self-monitoring.
The FDA requested supplemental documentation related to chemistry, manufacturing and controls rather than new clinical or preclinical data. The companies plan to resubmit the application and request a priority review by the end of July.