AbbVie Submits Supplemental New Drug Application to U.S. FDA For IMBRUVICA® (ibrutinib) in Combination with Rituximab for the Treatment of Previously Untreated, Younger Adults with Chronic Lymphocytic Leukemia

- Application is being reviewed under the FDA's Real-Time Oncology Review pilot program

- Submission is based on positive results from the Phase 3 E1912 clinical trial, which showed significantly improved progression-free survival and overall survival in patients treated with IMBRUVICA plus rituximab, compared to the FCR chemoimmunotherapy regimen

- If approved, the milestone will mark the 11th FDA approval for IMBRUVICA across six distinct disease areas

NORTH CHICAGO, IL, USA I November 8, 2019 I AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA® (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The submission is based on results from the Phase 3 E1912 study – designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. The study showed significantly improved progression-free survival (PFS) and overall survival (OS) in patients treated with IMBRUVICA plus rituximab, compared to those treated with fludarabine, cyclophosphamide and rituximab (FCR). Safety data were consistent with the known safety profile of IMBRUVICA. 

"While therapeutic approaches in chronic lymphocytic leukemia have improved dramatically over the past several years, chemoimmunotherapy, which can often be an aggressive course for even those who are fit enough to tolerate it, has remained a standard of care for many previously untreated patients," said Danelle James, M.D., M.A.S., IMBRUVICA Clinical Development Lead, Pharmacyclics LLC, an AbbVie company. "We are pleased that the FDA recognizes the urgent need to bring a more efficacious treatment option to younger adult patients with CLL who are considered candidates for chemoimmunotherapy. We look forward to working closely with the agency during the review of the landmark Phase 3 E1912 clinical trial data to bring the IMBRUVICA combination regimen to younger adult patients as quickly as possible."

The application is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, which allows the FDA to review data before the applicant formally submits the complete application. The program is designed to explore a more efficient review process to ensure safe and effective treatments become available to patients earlier, while maintaining quality of review.

IMBRUVICA is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

About the E1912 Study1 

Results from the Phase 3 E1912 study were presented during a Late-Breaking Abstract session at the 2018 American Society of Hematology (ASH) Annual Meeting and recently published in The New England Journal of Medicine. The study evaluated 529 previously untreated CLL patients aged 70 or younger, who were randomly assigned to receive IMBRUVICA plus rituximab (n=354) or the chemoimmunotherapy FCR (n=175). The primary endpoint was PFS with a secondary endpoint of OS. The study was led by ECOG-ACRIN with study site participation by groups in the NCI's National Clinical Trials Network (Alliance for Clinical Trials in Oncology, ECOG-ACRIN, NRG Oncology and SWOG), and was sponsored by the NCI. Pharmacyclics LLC supported the study through a Cooperative Research and Development Agreement with the NCI.

About IMBRUVICA

IMBRUVICA (ibrutinib) is an oral, once-daily medicine that works differently than chemotherapy as it blocks a protein called Bruton's tyrosine kinase (BTK). The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiple and spread.2,3 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.4

Since its launch in 2013, IMBRUVICA has received 10 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström's macroglobulinemia (WM); previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.5

IMBRUVICA is now approved in 95 countries and has been used to treat more than 170,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for CLL recommends ibrutinib (IMBRUVICA®) as a preferred regimen for the initial treatment of CLL/SLL and it is the only Category 1 single-agent regimen for treatment-naïve patients without deletion 17p.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. For more information, visit www.IMBRUVICA.com.

*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

1 Shanafelt, T., et al. Ibrutinib–Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia. The New England Journal of Medicine. August 1, 2019. https://www.nejm.org/doi/full/10.1056/NEJMoa1817073. Accessed October 2019. 
Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed October 2019.
Turetsky, et al. Single cell imaging of Bruton's Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014).
4 de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594.
5 IMBRUVICA U.S. Prescribing Information, September 2019.

SOURCE: AbbVie

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