FDA Approves Subcutaneous Administration of Rituximab for Three Lymphoma Types

On June 22, 2017, the United States Food and Drug Administration (FDA) approved subcutaneous injection of rituximab plus hyaluronidase human for people with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). Subcutaneous administration refers to the method of delivering a drug under the skin rather than directly into a vein as performed during intravenous (IV) administration.

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Administration of rituximab under the skin tends to take less than 10 minutes, whereas the traditional IV method can last several hours. The technique also allows for fixed dosing, which can reduce preparation time and excess drug waste, and may be more cost effective than IV infusion.

The approved treatment is to be employed only after patients have received at least one cycle of intravenous rituximab.

Approval comes based on the results of a series of clinical trials demonstrating comparable safety and efficacy outcomes across subcutaneous and intravenous administration.

Lymphoma Researchers Receive LRF Grants to Investigate Potential New Treatments

Last week the Lymphoma Research Foundation (LRF) announced the awarding of $1.62 million in funding for lymphoma research and lymphoma related training grants. Among the awardees were two Lymphoma Program research collaborators, Dr. Leandro Cerchietti and Dr. Pilar Dominguez Rodriguez.

Leandro Cerchietti
Leandro Cerchietti, M.D.

Dr. Cerchietti is an Assistant Professor of Medicine and Raymond and Beverly Sackler Research Scholar at Weill Cornell Medicine. He received a grant from the LRF for his work in predicting follicular lymphoma transformation without biopsy. For follicular lymphoma (FL) patients their slow growing tumor can turn into a much more aggressive follicular lymphoma that limits their treatment options. The mechanisms behind these transformations are poorly understood, but researchers are trying to better understand the mechanism of transformation. Currently invasive and expensive biopsies are the only way to determine whether a patient is at risk for follicular transformation. Based on his previous research Dr. Cerchietti has determined that FL cells release certain products into a patient’s body, and that these products in the bloodstream can be used to anticipate FL transformation. Dr. Cerchietti plans to build on his previous research and potentially develop new non-chemotherapy treatments for follicular lymphoma.

mariadelpilar
Pilar Dominguez Rodriguez, Ph.D.

Dr. Dominguez Rodriguez is a Post-Doctoral Associate, who specialized in cancer biology in Dr. Ari Melnick’s lab at Weill Cornell Medicine. Her current research focuses on the ten eleven translocation 2 (TET2) gene. TET2 is associated with DNA methylation, a process involved in the regulation of certain genes. Previously in patients with diffuse large B-cell lymphomas (DLBCL) the deregulation of DNA methylation has been identified as a source of DLBCL cell growth. However, researchers are still searching for answers as to why the methylation mechanisms malfunction. TET2 could potentially be a link due to its role in DNA methylation and the fact that is frequently mutated in lymphomas. Dr. Dominguez Rodriguez project seeks to discover whether there is a relationship between TET2 and DNA methylation in B-cells, and then identify how TET2 affects the development of DLBCL. If this relationship can be established the findings have the potential to identify new treatment targets for patients with B-cell lymphomas.

ACP-196: What You Should Know about this New Agent for B-cell Lymphomas and CLL

What is it?

ACP-196 is a second generation Bruton’s tyrosine kinase (BTK) inhibitor that can be taken orally. It was developed as an alternative to ibrutinib and was designed to be more selective in targeting BTK. Like ibrutinib it inhibits BTK, a protein important in the development, activation, proliferation, and survival of B-cells. ACP-196 is currently being investigated as a treatment for various B-cell lymphomas, as well as chronic lymphocytic leukemia (CLL).

How does ACP-196 work?

ACP-196 works by inhibiting the activity of BTK, a protein important in the development of B-cells. By preventing the activation of the B-cell antigen receptor signaling pathway, it slows down the growth of cancerous B-cells caused by the overactive BTK.

Does ACP-196 have any side effects?

The side effects for ACP-196 are acceptable and manageable with very few side effects being considered severe.

What is the difference between ACP-196 and ibrutinib?

ACP-196 and ibrutinib are similar in that they both inhibit BTK using the same binding site. They also are both effective in treating chronic lymphocytic leukemia cells. The difference is that ACP-196 inhibits fewer off target enzymes. By being more specific for BTK, the drug may have fewer side effects than ibrutinib, while maintaining similar anti-cancer activity.

How can I access ACP-196?

There are currently numerous clinical trials opened at Weill Cornell Medicine that use ACP-196 for various indications of CLL and B-cell lymphomas. A full list can be found on our Joint Clinical Trials website.