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FDA Accepts Application for Bristol-Myers Squibb and bluebird bio's Multiple Myeloma CAR-T Therapy

By Todd Campbell – Sep 22, 2020 at 1:20PM

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The Food and Drug Administration's acceptance means it will issue a go/no-go decision on ide-cel in March 2021.

A novel approach to multiple myeloma treatment developed by Bristol-Myers Squibb (BMY -0.39%) and bluebird bio (BLUE 2.31%) took an important step toward commercialization on Tuesday when the Food and Drug Administration announced that it had accepted their application for approval of ide-cel, also known as bb2121.

A chimeric antigen receptor T-cell (CAR-T) therapy, ide-cel elicited a 73% overall response rate in multiple myeloma patients whose disease had returned following a median of three previous treatments.

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The biotech companies specifically engineered ide-cel to trigger cancer cell death by recognizing and binding to B-cell maturation antigen, or BCMA, a protein expressed predominately by multiple myeloma cells.

In addition to its high overall response rate, 33% of heavily pretreated multiple myeloma patients had a complete response to ide-cel in clinical trials. The median duration of response was 10.7 months and median progression-free survival was 8.8 months. In terms of safety, 84% of patients experienced cytokine release syndrome, or CRS, a potentially life-threatening condition that's common in currently approved CAR-T therapies. Of these cases, 78% were mild or moderate.

An FDA decision on ide-cel is expected on March 27. If the treatment is approved, it will enter a competitive indication. The most widely used multiple myeloma drugs generate billions in revenue annually, including Bristol-Myers' Revlimid, which posted sales of $2.9 billion in the second quarter.

Todd Campbell owns shares of Bluebird Bio and Bristol-Myers Squibb. His clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Bluebird Bio and Bristol Myers Squibb. The Motley Fool has a disclosure policy.

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