january, 2019

01janAll Day31marABBV PDUFA Imbruvica and Gazyva ILLUMINATE

Event Details

Imbruvica and Gazyva – ILLUMINATE for chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). sNDA accepted for priority review noted October 17, 2018. PDUFA date not given. Estimate Q1 2019.

AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab (GAZYVA®) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

– If granted, IMBRUVICA plus obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for first-line CLL treatment
– The submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial, which showed longer progression-free survival for IMBRUVICA plus obinutuzumab versus chlorambucil plus obinutuzumab in CLL/SLL

NORTH CHICAGO, Ill.Oct. 17, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). If the sNDA is approved, the use of IMBRUVICA with obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for the first-line treatment of CLL/SLL. IMBRUVICA is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all lines of therapy and in combination with bendamustine and rituximab (BR).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.

“Our robust clinical research program with IMBRUVICA continues to reinforce the evidence for its use as an efficacious treatment option in CLL and SLL, this time versus a National Comprehensive Cancer Network guidelines Category 1 treatment, which is the chemoimmunotherapy combination of chlorambucil plus obinutuzumab,”said Danelle James, M.D., M.A.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company. “Further, for the first time in CLL, results from iLLUMINATE have shown the potential benefits of using an IMBRUVICA-based, chemotherapy-free, anti-CD20 combination. Since its initial approval five years ago, IMBRUVICA has received nine FDA approvals across six different diseases, and we remain committed to advancing new research to understand its full potential in blood cancers like CLL and SLL, as well as other difficult-to-treat diseases with unmet medical needs.”

The sNDA submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial announced in May 2018, which showed IMBRUVICA plus obinutuzumab was associated with significantly longer progression-free survival (PFS) versus chlorambucil plus obinutuzumab in adults with previously untreated CLL/SLL, as assessed by an Independent Review Committee.

CLL is one of the two most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes).While these cancer cells start in the bone marrow, they then later spread into the blood. The prevalence of CLL is approximately 115,000 patients in the U.S. with approximately 20,000 newly diagnosed patients every year.4,5 SLL is a slow-growing lymphoma biologically similar to CLL in which too many immature white blood cells cause lymph nodes to become larger than normal.CLL/SLL are predominately diseases of the elderly, with a median age diagnosis ranging from 65-70 years.7

About iLLUMINATE
iLLUMINATE (NCT 02264574) is a Pharmacyclics-sponsored, randomized, multi-center, open-label, Phase 3 study of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab in patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). According to the study protocol, patients enrolled are age 65 years and older or if less than age 65 years must have had at least one of the following criteria: Cumulative Illness Rating Score (CIRS) >6 and Creatinine clearance estimated <70 mL/min using Cockcroft-Gault equation. In the study, patients were randomized to receive IMBRUVICA 420 mg continuously in combination with obinutuzumab 1000 mg intravenously over 6 cycles or chlorambucil on Days 1 and 15 of each cycle plus obinutuzumab 1000 mg intravenously over 6 cycles. The primary endpoint is progression-free survival by Independent Review Committee (IRC), with secondary objectives including overall response rate and rate of minimal residual disease (MRD)-negative responses. As announced in May 2018, the study met its primary endpoint, showing significantly longer progression-free survival (PFS) was associated with adult CLL/SLL patients treated with IMBRUVICA plus obinutuzumab versus chlorambucil plus obinutuzumab, as assessed by an IRC.

About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by inhibiting a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.8 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.

IMBRUVICA is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and previously-treated chronic graft-versus-host disease (cGVHD).1

  • IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in November 2013.
  • Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
  • IMBRUVICA was approved for adult patients with WM in January 2015.
  • In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with CLL/SLL.
  • In January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
  • In August 2017, IMBRUVICA was approved for adult patients with cGVHD that failed to respond to one or more lines of systemic therapy.
  • In August 2018, IMBRUVICA plus rituximab was approved for adult patients with WM.

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.

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 new Breakthrough Therapy Designation pathway.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 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. To date, more than 120,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.



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