Bristol Myers announced the FDA has granted accelerated approval of Breyanzi, a CD19-directed chimeric antigen receptor, or CAR, T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL, who have received at least two prior lines of therapy, including a Bruton tyrosine kinase, or BTK, inhibitor and a B-cell lymphoma 2, or BCL-2, inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial. In R/R CLL or SLL, Breyanzi is delivered through a treatment process which culminates in a one-time infusion* with a single dose containing 90 to 110 x 106 CAR-positive viable T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome, Neurologic Toxicities, and Secondary Hematological Malignancies.
Confident Investing Starts Here:
- Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions
- Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See today’s best-performing stocks on TipRanks >>
Read More on BMY:
- Bristol Myers’ repotrectinib receives FDA orphan designation
- Bristol-Myers Squibb (NYSE:BMY) Shrugs off Analyst Cut
- Bristol Myers downgraded to Hold from Buy at Societe Generale
- Bristol Myers reports FDA approves Opdivo for first-line metastatic UC treatment
- Healthcare Stocks Retreat after New Task Force Is Formed