2020-04-24| Trials & Approvals

Imbruvica, AbbVie’s Answer to Chemo-Free Leukemia Treatment Gets FDA Approval

by Tulip Chakraborty
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By T. Chakraborty, Ph.D.

On April 21st, AbbVie, one of the largest research-based global biopharmaceutical company, announced the USFDA approval for Imbruvica (ibrutinib) in combination with rituximab for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This approval is Imbruvica’s 11th since its first in 2013, and a remarkable landmark for the company, which aims to bring a chemo-free treatment option to patients with CLL.

“The gold-standard first-line treatment option for many patients with chronic lymphocytic leukemia who were fit enough to tolerate an aggressive treatment course had been the intravenous chemoimmunotherapy of FCR – that is, until today,” said Brian Koffman, M.D., C.M., CMO, and Executive V.P. of the CLL Society. “The FDA approval of ibrutinib and rituximab regimen is welcome news for these previously untreated patients who have been looking forward to a non-chemotherapy treatment option. The results from ECOG-ACRIN’s E1912 clinical trial in previously untreated, younger adult patients and today’s milestone represent a paradigm shift in how physicians can treat patients with CLL and may enable many to choose a non-chemotherapy treatment option.”


Imbruvica, the BTK Inhibitor Drug

Imbruvica is a once, daily, orally administered cancer drug with the potential to treat some life-threatening forms of cancer. It is an inhibitor of Bruton’s tyrosine kinase (BTK), a non-receptor kinase that plays an essential role in regulating the proliferation and survival of cancer cells in B-cell malignancies. First shown to be defective in primary immunodeficiency X-linked agammaglobulinemia (XLA), BTK plays a crucial role in B cell development and maturation making it a potential drug target. The drug is one of the most widely studied BTK inhibitor, which is currently used in close to 150 ongoing clinical trials around the world, of which 14 are in Phase 3.

Since 2013, Imbruvica has received “11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion, small lymphocytic lymphoma (SLL) with or without del17p, Waldenström’s macroglobulinemia (W.M.), and previously-treated patients with mantle cell lymphoma (MCL).” It is approved in 95 countries and has been successfully used in close to 200,000 patients worldwide. Further, Imbruvica had been granted the Breakthrough Therapy Designation by the USFDA, which allows expedited development of new drugs for life-threatening conditions like cancer and was one of the first drugs to be approved through this pathway.


The E1912 study

The FDA approval is based on the positive results from the historic Phase 3, E1912 study, which was orchestrated by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI). This is the third Phase 3 randomized study granted under FDA’s Real-Time Oncology Review pilot program, Project Orbis and priority review, an enterprise of the FDA Oncology Center of Excellence, whose duty includes providing a frame for submitting and reviewing oncology medicine applications.

The study evaluated a combination of Imbruvica and rituximab, a CD20-targeting chimeric monoclonal antibody on 529 CLL patients who were 70 years or younger. Results demonstrated that patients receiving the combo therapy had a statistically higher progression-free survival rate compared to a potent chemoimmunotherapy regimen comparator of fludarabine, cyclophosphamide, and rituximab (FCR). Fatigue, musculoskeletal pain, rash, hypertension, nausea, and headache were some of the common side effects observed with the combo therapy. The results were presented at the American Society of Hematology (ASH) Annual Meeting last year.

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Editor: Rajaneesh K. Gopinath, Ph.D.



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