The Pharma Data

JUNE 18, 2021

Imbruvica Global Development Lead, Pharmacyclics LLC, an AbbVie company. Abstract EP635 ) Real-World Application of NCCN Clinical Practice Guidelines (NCCN Guidelines ® ) for CLL/SLL from the informCLL Prospective Observational Registry. .” IMBRUVICA is a registered trademark of Pharmacyclics LLC. SOURCE AbbVie Inc.

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

This rate was higher than the 37% minimum meaningful rate study assumption (P<0.0001). Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase. . AbbVie Inc. months of follow up. The CR rate was consistent across all patients in the study including high-risk CLL patient groups.

Medicine 40

Medicine Production FDA Approval Trials 40