The LLS Praises the FDA’s Approval of Blinatumomab

Blinatumomab pic

Melville, NY, resident Ellen Scharaga is committed to helping others. Beyond promoting improved medical patient outcomes through her role as an operational consultant for Alegria Specialty Pharmacy, she supports several charitable organizations. One of the many organizations Ellen Scharaga supports is the Leukemia and Lymphoma Society (LLS).

For more than 65 years, the LLS has been committed to educating the public, helping patients with blood cancer, and funding blood cancer research. The organization recently praised the United States Food and Drug Administration’s approval of blinatumomab as a treatment for individuals with a unique form of acute lymphoblastic leukemia. The therapy, which is a bispecific antibody T-cell engager, directs the body’s T cells to a specific protein found on the surface of B cells, including B-cell lymphomas and leukemias. Modified antibodies then engage a specific target on both the T cell and B cell, forcing the two cells to connect to one another and allowing the T cell to destroy the other cell.

Blinatumomab received the FDA’s Breakthrough Therapy designation in mid-2014 and was approved for patients with refractory B-cell precursor or Philadelphia chromosome-negative relapsed acute lymphoblastic leukemia in early December. The FDA will maintain its approval of the treatment once its clinical benefit is proven through additional research trials.


The Leukemia and Lymphoma Society Sends Representative to Capitol Hill

Ellen Scharaga of Melville, NY, oversees oncology pharmacy operations and services at OncoMed Pharmaceutical Services. Aside from her professional duties, Ellen Scharaga also supports cancer charities, including the American Cancer Society and The Leukemia and Lymphoma Society (LLS).

Recently, LLS’ Chief Scientific Officer, Dr. Lou DeGennaro, spoke to a U.S. Congressional committee about the importance of personalized medicine and related Food and Drug Administration (FDA) policy concerns. In total, a dozen participants joined the discussion on the U.S. House Energy and Commerce Committee’s 21st Century Cures initiative, which seeks to improve patient access to new therapies and remove obstacles to their development.

On behalf of oncologists and their patients, Dr. DeGennaro advocated for reform in the FDA approval process to allow innovative and novel treatments to move forward, even when they do not fit the conventional clinical trial path. One of the specific therapies the doctor supports is identifying the mutations that lead to acute myeloid leukemia (AML) and allowing researchers to develop new combinations of cancer therapies to treat and stop those mutations.