FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer

Friday, the FDA approved Bristol-Myers Squibb Company BMY and  2seventy Bio Inc’s TSVT Abecma (idecabtagene vicleucel; ide-cel) for adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy.

The approval is based on results from the KarMMa-3 trial that showed Abecma helped extend the time before disease progression by 13.3 months on average in patients whose cancer has returned or stopped responding to at least two prior treatments compared to 4.4 months progression-free survival seen in trial patients who received standard of care.

This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. 

Abecma is currently approved for adults with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.

Related: Focus On Bristol Myers, Gilead Sciences, Johnson & Johnson, Novartis: FDA To Issue Classwide Black Box Warning on CAR-T Therapies For Blood Cancer Treatment.

Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. 

The FDA pushed the approval date from 16 December 2023.

Last month, the FDA’s Oncologic Drugs Advisory Committee voted positively (8-3) favoring the expanded use of Abecma.

The panel said Abecma demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on the pivotal Phase 3 KarMMa-3 study results, including the key secondary endpoint of overall survival. 

Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome, Neurologic Toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome, Prolonged Cytopenia, and Secondary Hematological Malignancies.

Price Action: BMY shares are down 0.15% at $51.32, and TSVT shares are up 3.99% at $5.21 on the last check Friday.

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