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
FDA Approvals, News & UpdatesLeukemia
Tibsovo Approved for First-Line Treatment of Patients with Acute Myeloid Leukemia and IDH1 Mutation
In May 2019, the FDA approved Tibsovo for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) and an IDH1 mutation, or for patients with AML who are unable to use intensive chemotherapy.
Breast CancerFDA Approvals, News & Updates
Piqray New Treatment Approved for Metastatic Breast Cancer and PI3KCA Mutation
In May 2019, the FDA approved Piqray (alpelisib), the first PI3K inhibitor for the treatment of metastatic breast cancer with a PI3KCA mutation in postmenopausal women, and in men. An FDA spokesperson said it was the first treatment “to demonstrate a clinically meaningful benefit” for this type of breast cancer.
Bladder CancerFDA Approvals, News & Updates
Balversa First Targeted Drug Approved for Metastatic Bladder Cancer with FGFR Genetic Alterations
In April 2019, the FDA approved Balversa, an FGFR kinase inhibitor, for the treatment of adults with advanced or metastatic bladder cancer and an FGFR genetic alteration, as determined by an FDA-approved diagnostic test. This is the first FDA-approved targeted drug for patients with this specific genetic mutation.
Last modified: June 11, 2019

Subscribe to CONQUER: the patient voice® magazine

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

Country