Fred Hutch Statement Regarding the FDA Action on CTL019 Immunotherapy

Fred Hutch Statement Regarding the FDA Action on CTL019 Immunotherapy

Dr. David Maloney

Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutch and medical director of the Bezos Family Immunotherapy Clinic at the Seattle Cancer Care Alliance.

Photo by Robert Hood / Fred Hutch News Service

Fred Hutch expert comments on FDA approval of new Novartis immunotherapy drug CTL019 — August 30, 2017

Today the U.S. Food and Drug Administration approved the use of a new Novartis immunotherapy drug, CTL019, as a treatment for advanced cases of leukemia in children and young adults. 

This latest FDA ruling validates the importance of similar lifesaving cellular immunotherapies currently being developed and tested by Fred Hutchinson Cancer Research Center and other National Cancer Institute-designated cancer centers.

Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutch and medical director of the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance, Fred Hutch’s clinical care partner, offered the following statement:

“Although narrow in scope, today’s 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 under way in the field of cellular immunotherapy where we are modifying cells from a patient’s own immune systems to seek out and eliminate cancer cells. We at the 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.

FOR THE MEDIA

Hutch Team

For more information or to arrange an interview, please contact Jonathan Rabinovitz at 206.667.6906 (office), 206.658.7612 (mobile) or email at jrabinov@fredhutch.org.

“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 R&D 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 are available to more patients.”

Fred Hutch is currently testing new experimental T-cell therapies for breast cancer, leukemia, lymphoma, lung cancer, Merkel cell carcinoma and mesothelioma. 


Media Coverage

Hailing a breakthrough in fighting cancer, FDA approves gene therapy that functions as a ‘living drug’
Aug. 30, 2017 | Melissa Healy | Los Angeles Times

US clears breakthrough gene therapy for childhood leukemia
Aug. 30, 2017 | Lauran Neergaard (Associated Press) | ABC news

First cancer 'living drug' gets go-ahead
Aug. 30, 2017 | James Gallagher | BBC News

Landmark FDA approval clears the way for gene therapy treatments that fight cancer
Aug. 30, 2017 | Clare McGrane | GeekWire

Novartis Wins Historic FDA Nod, Prices CAR-T For Leukemia at $475,000
Aug. 30, 2017 | Alex Lash | Xconomy

Novartis Goes First
Aug. 30, 2017 | Genome Web
subscription required to view

US clears breakthrough gene therapy for childhood leukemia
Aug. 30, 2017 | Lauran Neergaard (Associated Press) | The Seattle Times

US clears breakthrough gene therapy for childhood leukemia
Aug. 30, 2017 | Lauran Neergaard (Associated Press) | Star Tribune

US clears breakthrough gene therapy for childhood leukemia
Aug. 30, 2017 | Lauran Neergaard (Associated Press) | Sacramento Bee

Pioneering Cancer Gene Therapy Gets Green Light — And $475,000 Price Tag
Aug. 30, 2017 | Liz Szabo | Kaiser Health News (photo only)

FDA's CTL019 Ruling Validates Importance of Similar Lifesaving Cellular Immunotherapies Currently Being Developed and Tested by Fred Hutch and Other NCI-Designated Cancer Centers
Aug. 301, 2017 | Newswise