Logo

Verastem Oncology's Copiktra (duvelisib) Receives FDA Approval for r/r 2L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Share this

Verastem Oncology's Copiktra (duvelisib) Receives FDA Approval for r/r 2L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)


Shots:

  • The approval is based on DUO (NCT02004522) & DYNAMO (NCT01882803) study results assessing Copiktra (25msg bid) vs ofatumumab or rituximab and to either CT or radioimmunotherapy in 319 adults in ratio (1:1) in patients with 2L+ r/r CLL/SLL or 2l+ r/r FL respectively
  • DUO study results: PFS: no of events (55% vs 70%); progression disease (44% vs 62%); Death (11 vs 8); mPFS (16.4 vs 9.1 mos.); ORR (74% vs 39%); PR (74% vs 39%): DYNAMO study results: ORR 42%- CR 1%- PR 41%- patience maintaining response @ 6mos- 12 mos. (43%- 17%)
  • Copiktra (duvelisib) is an PO inhibitor of phosphoinositide 3-kinase (PI3K) and a novel dual inhibitor of PI3K-delta and PI3K-gamma indicated for adult with 2L+ r/r CLL/SLL or 2l+ r/r FL 

Ref: Verastem Oncology | Image: Twitter

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions