gdc
FDA Approvals, News & UpdatesLeukemia

FDA Approves Imbruvica plus Gazyva for First-Line Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This new chemotherapy-free combination of Imbruvica, a targeted therapy, plus Gazyva, a CD20-directed cytolytic antibody, was recently approved by the FDA as first-line treatment of adults aged 65 or older who are newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
April 2019 Vol 5 No 2

Based on the results of a recent clinical trial presented at ASH 2018 and discussed in CONQUER magazine in December 2018 (https://conquer-magazine.com/categories/leukemia), in January 2019 the FDA approved the combination of the oral Bruton’s tyrosine kinase inhibitor Imbruvica (ibrutinib; from Pharmacyclics) plus the CD20-directed cytolytic antibody Gazyva (obinutuzumab; from Genentech), for use as the first treatment in older adults (aged 65 or older) with chronic lymphocytic leukemia (CLL) or with small lymphocytic lymphoma (SLL). Imbruvica was already approved as a single agent for different treatments, including for adults with CLL or SLL, with or without 17p deletion.

This new approval was based on a phase 3 clinical trial that included 229 patients with newly diagnosed CLL or SLL who were aged 65 years or older, and who had additional medical conditions, such as kidney disease and/or 17p deletion or TP53 gene mutation. The patients received Imbruvica plus Gazyva or chemotherapy plus Gazyva.

After almost 3 years of treatment, the patients who received the combination of Imbruvica plus Gazyva had a much longer period without disease progression than those who received chemotherapy plus Gazyva. In fact, the average period without disease progression was not yet reached with Imbruvica plus Gazyva, meaning patients are continuing to respond to treatment without disease progression, com­pared with only 19 months in the comparison group.

The most common side effects with Imbruvica plus Gazyva were an increased risk for infection (neutropenia), platelet deficiency, rash, diarrhea, musculoskeletal and joint pain, bruising, cough, infusion-related reaction, and bleeding (hemorrhage).

Recommended For You
Leukemia
CAR T-Cell Therapy Emerging for Chronic Lymphocytic Leukemia
Chimeric antigen receptor (CAR) T-cell therapy could soon expand into chronic lymphocytic leukemia (CLL). Early clinical trials have shown responses in patients with CLL refractory to other therapies. Predicting which patients will respond is key to advancing CAR T-cell therapy into CLL.
Leukemia
Targeted Therapy Dominates CLL Treatment Landscape
Targeted therapy is at the forefront of chronic lymphocytic leukemia (CLL) treatment. In many cases, targeted agents offer superior outcomes to chemotherapy, with more manageable side effects. Multiple targeted therapy options are available, and some choices depend on certain molecular markers.
Leukemia
Cytogenetic Testing in Chronic Lymphocytic Leukemia
Cytogenetic testing is used to identify genomic aberrations in patients with chronic lymphocytic leukemia (CLL). It estimates a patient’s outcomes and can predict response to certain therapies, and therefore is recommended for all patients with CLL at diagnosis.
Leukemia
Acalabrutinib Alone or in Combination More Effective than Chemoimmunotherapy in Previously Untreated CLL
A new study presented at a major medical meeting showed that fewer patients with treatment-naïve chronic lymphocytic leukemia (CLL) who were treated with acalabrutinib alone or in combination with obinutuzumab had disease progression or died compared with a group of patients treated with the combination of obinutuzumab and chemotherapy.
Last modified: June 11, 2019

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.

Country