FDA approves ibrutinib Plus Rituximab for treating Chronic Lymphocytic Leukemia

HORSHAM -- The U.S. Food and Drug Administration (FDA) has granted approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy.

The approval has been granted to the Janssen Pharmaceutical Companies of Johnson & Johnson .

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 Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.

IMBRUVICA® is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA® has been granted four Breakthrough Therapy Designations by the FDA, and it was one of the first medicines to receive U.S. approval with the Breakthrough Therapy Designation.

The approval is based on positive results from the landmark Phase 3 E1912 study that was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. Today's milestone marks the 11th U.S. FDA approval for IMBRUVICA® across six disease areas and is the sixth approval for IMBRUVICA® in CLL.

The E1912 study showed newly diagnosed patients ages 70 years or younger (median age of 58 years) treated with IMBRUVICA® plus rituximab lived longer without disease progression, with a progression-free survival (PFS) rate of 88 percent at 37 months, compared to patients treated with fludarabine, cyclophosphamide and rituximab (FCR), with a PFS rate of 75 percent. Extended follow-up results from the E1912 study were most recently presented at the 2019 American Society of Hematology (ASH) Annual Meeting.

"FCR, a chemoimmunotherapy-based regimen, has been the standard of care for many previously untreated younger patients with CLL. With the introduction of this ibrutinib-rituximab combination, patients now have a more effective, non-chemoimmunotherapy option," said Brian Koffman, M.D., C.M. (retired), Co-Founder and Chief Medical Officer/Executive Vice President, CLL Society, a nonprofit organization focused on CLL patient education, support and research. "In the 14 years since I was first diagnosed with CLL, the treatment landscape has advanced dramatically for the better, with ibrutinib continuing to play a pioneering role in defining what it means to live with this disease."

The IMBRUVICA® application received approval through the U.S. FDA's Real-Time Oncology Review (RTOR) pilot program and received Priority Review designation. Additionally, the approval was granted under a modified version of the newly established Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for submission and review of oncology medicine applications among international regulatory agencies.1

"We commend the ECOG-ACRIN Cancer Research Group and the National Cancer Institute for conducting a robust study that has generated insightful and landmark results in the treatment of CLL," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "We are committed to the continued study of IMBRUVICA-based regimens and building upon the efficacy and safety of the most comprehensively studied BTK inhibitor in our efforts to improve the lives of patients facing a blood cancer diagnosis."

Warnings and Precautions include: hemorrhage, infections, cytopenias, cardiac arrhythmias, hypertension, second primary malignancies, tumor lysis syndrome, and embryo-fetal toxicity. In the E1912 study, the most common adverse reactions (occurring in 15 percent or more of patients) of all Grades in patients treated with IMBRUVICA® plus rituximab were fatigue (80 percent), musculoskeletal pain* (61 percent), diarrhea (53 percent), rash* (49 percent), hypertension* (42 percent), arthralgia (41 percent), nausea (40 percent), headache (40 percent), bruising* (36 percent), cough (32 percent), hemorrhage* (31 percent), upper respiratory tract infection (29 percent), peripheral edema (28 percent), pyrexia (27 percent), pain (23 percent), stomatitis* (22 percent), and dyspnea (22 percent).

The recommended dosage of IMBRUVICA® for CLL/SLL is 420 mg orally once a day until disease progression or unacceptable toxicity. For CLL/SLL, IMBRUVICA® can be administered as a single agent, in combination with rituximab or obinutuzumab, or in combination with bendamustine and rituximab (BR). When administering IMBRUVICA® in combination with rituximab or obinutuzumab, consider administering IMBRUVICA® prior to rituximab or obinutuzumab when given on the same day.

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