U.S. FDA Approves Bristol Myers Squibb’s Breyanzi ® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

PRINCETON, N.J.–Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (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(s). 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.Continue reading

The New England Journal of Medicine Publishes Cologuard Plus™ Test Results from Pivotal BLUE-C Study

Cologuard Plus is only noninvasive test to be evaluated head-to-head against an independent fecal immunochemical test, which it significantly outperformed

20,000-participant BLUE-C study included 98 colorectal cancers and reflects racial and ethnic diversity of U.S.

Company will host conference call and webcast at 8:00 a.m. ET on March 14 to discuss study resultsContinue reading

AdvaMed board chair Peter J. Arduini announces top priorities to guide the future of MedTech 

WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, announced Board Chairman Peter Arduini’s priorities to guide the vision of the medtech industry over the course of his two-year term. The priorities, which are established by each new Board chair, come as AdvaMed, the leading trade association, renews its advocacy efforts in Washington and globally to address key issues impacting medtech companies and the providers and patients they serve.Continue reading

City of Hope-developed chimeric antigen receptor (CAR) T cell therapy shows clinical activity in patients with aggressive brain tumors in a Phase 1 trial

  • Half of the enrolled patients had stable disease for at least two months, two showed partial response and two experienced complete response
  • Nature Medicine paper highlights delivery of CAR T cell therapy directly to the brain, a technique City of Hope developed
  • This is the largest reported trial to date of CAR T therapy for solid tumors

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