Pharmacyclics – Ibrutinib: A Game Changer – 3 Breakthrough Therapy Designations + More Data ASCO/EHA ‘13
ASCO ‘13 abstracts highlight Ibrutinib (PCI-32765, PhIII, BTK inhibitor, partnered with JNJ, PhIII, CLL/SLL/PLL, MCL; PhII, DLBCL, MM, FL) leads in the new treatment options in development for hematological malignancies. Ibrutinib, a small molecule is being studied as a monotherapy and has shown robust efficacy and safety vs. GILD’s PI3K inhibitor, Idelalisib (PhIII, CLL; PhII, NHL). Breakthrough Therapy Designation has been granted by FDA to Ibrutinib for R/R MCL, Waldenstrom's macroglobulinemia (WM), and Chronic Lymphocytic Leukemia (CLL) with deletion of chromosome 17p and approvals/ launches in 17p deletion CLL and MCL are almost certain (in 2014 and can even happen earlier!). Upcoming milestones by year end and … For more detail, please read our report released on May 24, 2013, titled, “Ibrutinib: A Game Changer – 3 Breakthrough Therapy Designations + More Data @ ASCO/EHA ‘13”.
