Replies to post #210428 on Biotech Values

[DewDiligence]

ABBV/JNJ—FDA approves Imbruvica for cGVHD:

http://www.prnewswire.com/news-releases/us-fda-approves-imbruvica-ibrutinib-as-first-approved-treatment-specifically-for-adults-with-chronic-graft-versus-host-disease-cgvhd----a-serious-potentially-life-threatening-condition----after-failure-of-one-or-more-lines-300498499.html

[DewDiligence]

ABBV/JNJ—Imbruvica phase-3 in non-GCB DLBCL fails primary endpoint:

https://www.prnewswire.com/news-releases/janssen-provides-update-on-imbruvica-ibrutinib-phase-3-phoenix-trial-in-newly-diagnosed-non-germinal-center-b-cell-non-gcb-subtype-of-diffuse-large-b-cell-lymphoma-dlbcl-300679111.html

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today topline results from the Phase 3 PHOENIX trial evaluating the investigational use of IMBRUVICA (ibrutinib) in the treatment of newly diagnosed non-Germinal Center B cell (non-GCB) subtype of diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma (NHL).

The study compared IMBRUVICA plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) versus R-CHOP, the current standard of care in DLBCL. The clinical trial did not meet the primary endpoint of event-free survival in patients with non-GCB subtype of DLBCL, including activated B cell-like (ABC) subtype of DLBCL. Janssen is conducting further analyses of the PHOENIX study results to assess the potential efficacy of IMBRUVICA as observed in a patient sub-population.