Tag: CLL

Obinutuzumab Approved for Patients with Previously Untreated CLL

Last week the FDA announced approval for obinutuzumab (Gazyva) in combination with chlorambucil for the treatment of patients with previously untreated CLL. Obinutuzumab is the first designated “Breakthrough Therapy” to be granted FDA approval, receiving a priority review through its demonstration of “significant improvement” in safety or effectiveness over available therapies.

Obinutuzumab is a 3rd generation type II anti-CD20 antibody. Acting as an immunomodulator, obinutuzumab selectively binds to the extracellular domain of the human CD20 antigen on malignant human B cells.

This “significant improvement” was demonstrated in a phase III study. Patients treated with a combination of obinutuzumab and chlorambucil experienced significant improvement in progression free survival, increasing to an average of 23 months, compared to 11 months for chlorambucil therapy.

The FDA press release can be seen here. Further information regarding CLL clinical trials at Weill Cornell Medical College can be found here.

Idelalisib Study for CLL Patients Ended Early Due to Positive Findings

On October 9, Gilead Sciences Inc., announced an exciting new development for CLL patients. An independent Data Monitoring Committee (DMC) recommended that a Phase 3 study of Idelalisib in previously-treated CLL patients be ended early, due to evidence of efficacy. As Gilead noted,

“This DMC recommendation is based on a predefined interim analysis showing highly statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those receiving rituximab alone. The safety profile of idelalisib was acceptable and consistent with prior experience in combination with rituximab in previously treated CLL. Gilead has informed the U.S. Food and Drug Administration (FDA) of the plan to end the study and will engage in a dialogue with the FDA regarding a regulatory filing in CLL.”

Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President , Research and Development and Chief Scientific Officer explained,

“This is the first Phase 3 study to report positive results for a new class of targeted therapies that inhibit B-cell receptor signaling as a major component of their mechanism of action, an important area of focus in the development of chemotherapy-free regimens in CLL and other B-cell malignancies. We extend thanks to the investigative sites and to the other research collaborators participating in this study, as well as to the patients who volunteered, and we look forward to sharing these data with the hematology community.”

Prominent researchers involved in this study include the Lymphoma Program’s Dr. Richard Furman. Further data from this study will be submitted for upcoming scientific conferences. Please look to this space to follow up with any further announcements regarding this new development.

 Gilead’s full press release can be found here.

Dr. Richard Furman Discusses Exciting New Treatments for CLL

While attending iwCLL 2013, Dr. Richard Furman, a nationally recognized CLL clinician and researcher here in the Lymphoma Program, sat down and gave his thoughts on the latest advances in CLL treatment, and how this will effect future patient outcomes.

The discussion can be found here.