Tag: chronic lymphocytic leukemia

FDA Approves Ibrutinib for Chronic Lymphocytic Leukemia

Last week the FDA announced the approval of ibrutinib for patients with chronic lymphocytic leukemia. According to their press release:

“The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.”

“CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013.”

“Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy.”

“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.”

 The full press release can be read on their website. 

The full listing of CLL trials at WCMC is available on the clinical trials website. Look to this space for further news concerning  ibrutinib trials for CLL patients at WCMC.

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.

Ofatumumab Granted Breakthrough Therapy Designation for Untreated CLL

Recently, on September 13 the FDA granted a Breakthrough Therapy Designation to ofatumumab (Arzerra) in combination with chlorambucil for previously untreated patients with chronic lymphocytic leukemia (CLL) who are inappropriate for fludarabine-based therapy. This designation is awarded to drugs whose preliminary clinical evidence suggests an improvement over existing therapies on one or more clinically significant endpoints, speeding the bench to beside process. The designation was granted after preliminary results from a phase 3 clinical trial involving over 400 patients was announced in May.

Ofatumumab is a monoclonal antibody that targets an epitope on the CD20 molecule that encompasses parts of the small and large extra-cellular loops. The CD20 molecule is found on over 90% of B-cell lymphomas and assorted lymphoid tumors with a B-cell origin. Ofatumumab effectively kills cancer cells by directing the body’s immune system against normal and cancerous B-cells, and attaching to the CD20 molecule located on the surface of cancerous B-cells.

In addition to the aforementioned purposes, ofatumumab is being investigated for treatment in follicular lymphoma, diffuse large B-cell lymphoma, and Waldenstrom’s Macroglobulinemia.

Currently, there are ongoing ofatumumab trials at the Weill Cornell Lymphoma Program open to patients with CLL. Additional listings of clinical trials for CLL & SLL patients can be found here.

Please stay updated with our clinical trials listings for forthcoming trials involving ofatumumab and the Cornell Lymphoma Program website for further clinical research updates.