Expert Point of View: David Maloney, MD, and Kenneth C. Anderson, MD
SIMILAR CELLULAR immunotherapies are currently being developed and tested by other National Cancer Institute–designated cancer centers, including Fred Hutchinson Cancer Research Center.
David Maloney, MD
David Maloney, MD, Medical Director of Cellular Immunotherapy at Fred Hutchinson and Medical Director of the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance, Fred Hutchinson’s clinical care partner, offered the following statement:
“Although narrow in scope, [the August 30] FDA ruling is a milestone. This is the first approval for the use of genetically engineered immune cells as a treatment for cancer and is an important validation of technical advances underway in the field of cellular immunotherapy, in which we modify cells from a patient’s own immune system to seek out and eliminate cancer cells. We at Fred Hutchinson Cancer Research Center believe this is just the first of what will soon be many new immunotherapy-based treatments for a variety of cancers.
“Approvals are an important step, but they’re just the beginning. The safety, availability, and affordability of these new immunotherapies can be improved, but to achieve these goals we need an increase in industry partnerships, more corporate investments, and continued government funding. This increased collaboration and funding will allow us to make further investments in fundamental research and development into how the immune system interacts with cancer and to pursue advances in cell-engineering techniques so that clinical trials can be accelerated and these experimental therapies be made available to more patients.”
Kenneth C. Anderson, MD
Kenneth C. Anderson, MD, of the Dana-Farber Cancer Institute, and President of the American Society of Hematology (ASH), issued the following statement on behalf of ASH:
“The approval of CAR T-cell therapy for pediatric leukemia marks an important shift in the blood cancer treatment paradigm. We now have proof that it is possible to eradicate cancer by harnessing the power of a patient’s own immune system. This is a potentially curative therapy in patients whose leukemia is unresponsive to other treatments and represents the latest milestone in the shift away from chemotherapy toward precision medicine. [The August 30] approval is the result of over a decade of hematology research, including research funded by the National Institutes of Health.
“While the importance of CAR T-cell therapy cannot be overstated, this approval only pertains to a small population of children. More research is needed to make this therapy more effective for a broader population, to reduce the severe side effects that patients experience during treatment, and ultimately to find a broader application beyond blood cancers.
“ASH is very excited to have contributed to the progress that has led to today’s approval and will continue to support research to refine CAR T-cell therapy.” ■
ON AUGUST 30, 2017, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for pediatric and young adult patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory to initial treatment or in second or later relapse....