FDA News

Imbruvica-Gazyva combination receives priority review for chronic lymphocytic leukemia

The FDA granted priority review to ibrutinib in combination with obinutuzumab for the treatment of previously untreated adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

If approved, the combination of ibrutinib (Imbruvica; Pharmacyclics/AbbVie, Janssen) and obinutuzumab (Gazyva, Genentech) would represent the first chemotherapy-free anti-CD20 combination indicated for the first-line treatment of CLL.

The decision was based, in part, on data from the phase 3 iLLUMINATE trial, for which researchers randomly assigned patients to receive 420 mg ibrutinib continuously in combination with 1,000 mg IV obinutuzumab over six cycles, or chlorambucil on days 1 and 15 of each cycle plus 1,000 mg IV obinutuzumab over six cycles.

As HemOnc Today previously reported, patients treated with ibrutinib plus obinutuzumab showed significantly improved PFS compared with patients treated with chemotherapy plus obinutuzumab.

“Our robust clinical research program with Imbruvica continues to reinforce the evidence for its use as an efficacious treatment option in CLL and small lymphocytic lymphoma [SLL], this time versus a National Comprehensive Cancer Network guidelines category 1 treatment, which is the chemoimmunotherapy combination of chlorambucil plus obinutuzumab,” Danelle James, MD, MAS, head of clinical science at Pharmacyclics, an AbbVie company, said in a press release. “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 5 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 FDA granted priority review to ibrutinib in combination with obinutuzumab for the treatment of previously untreated adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

If approved, the combination of ibrutinib (Imbruvica; Pharmacyclics/AbbVie, Janssen) and obinutuzumab (Gazyva, Genentech) would represent the first chemotherapy-free anti-CD20 combination indicated for the first-line treatment of CLL.

The decision was based, in part, on data from the phase 3 iLLUMINATE trial, for which researchers randomly assigned patients to receive 420 mg ibrutinib continuously in combination with 1,000 mg IV obinutuzumab over six cycles, or chlorambucil on days 1 and 15 of each cycle plus 1,000 mg IV obinutuzumab over six cycles.

As HemOnc Today previously reported, patients treated with ibrutinib plus obinutuzumab showed significantly improved PFS compared with patients treated with chemotherapy plus obinutuzumab.

“Our robust clinical research program with Imbruvica continues to reinforce the evidence for its use as an efficacious treatment option in CLL and small lymphocytic lymphoma [SLL], this time versus a National Comprehensive Cancer Network guidelines category 1 treatment, which is the chemoimmunotherapy combination of chlorambucil plus obinutuzumab,” Danelle James, MD, MAS, head of clinical science at Pharmacyclics, an AbbVie company, said in a press release. “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 5 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.”