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FDA Approves Ibrutinib plus Rituximab for Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration (FDA) has granted approval to the Janssen Pharmaceutical Companies of Johnson & Johnson to expand the indications for Imbruvica® (ibrutinib) to be used in combination with rituximab for the initial treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1-3

CLL is a type of blood and bone marrow cancer. This chronic form typically grows slower than other types of leukemia. It affects the white blood cells (lymphocytes) which help the body fight infection. Treatment with Imbruvica has previously been approved for the treatment of CLL as well as multiple other diseases.2

A new combination

Approval for this new drug combination was conducted through Project Orbis. This is a special program of the FDA Oncology Center of Excellence. It allows for the submission and review of cancer drugs among international partners at the same time.1 For this treatment, the FDA collaborated with international regulatory review programs in Australia, Canada, and Switzerland.1-3

Imbruvica is a targeted agent. It is a Bruton's tyrosine kinase (BTK) inhibitor that was already being used to treat CLL. It blocks the BTK protein from signaling cancer cells to grow and spread. This new treatment adds the use of the immunologic agent rituximab. This means the drugs that can modify the immune system’s response. It creates a first-line nonchemotherapy treatment option for people with CLL. This therapy has immediate implications in changing the practice patterns for treating CLL.2-3

Approval based on clinical trial data

This clinical trial was designed and conducted by the ECOG-ACRIN Cancer Research Group with sponsorship from the National Cancer Institute. The Phase 3 E1912 study showed positive results in newly diagnosed patients under age 70 (median age of 58 years) who were treated with Imbruvica plus rituximab. They lived longer without disease progression.1-3

The study evaluated 529 adult patients with previously untreated CLL. The progression-free survival (PFS) rate was 88 percent at 37 months. This is a significantly improved outcome compared to a rate of 75 percent PFS survival rate for those treated with a chemoimmunotherapy drug regimen -fludarabine, cyclophosphamide and rituximab (FCR). The study results were presented at the 2019 American Society of Hematology (ASH) Annual Meeting.1-3

What are the possible side effects of Imbruvica plus rituximab?

The most common side effects include:1-3

Important things to know about Imbruvica plus rituximab

Imbruvica was first approved in 2013.2 It has been used in combination with other drugs and as a monotherapy (single agent) for the treatment of CLL and numerous other diseases. This newly approved ibrutinib-rituximab combination now offers a more effective, non-chemoimmunotherapy treatment option.1-3

Imbruvica is taken by mouth once a day with a glass of water. The rituximab is not started until Cycle 2. It is taken on Day 1 and 2 of Cycle 2 and then on Day 1 of 5 subsequent cycles, for a total of 6 cycles.1-3

Read the full prescribing information for Imbruvica.

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