The Latest: FDA panel endorses potential 1st US gene therapy

Associated Press |

SILVER SPRING, Md. (AP) — The Latest on a Food and Drug Administration panel's review of a gene therapy treatment (all times local):

A panel of cancer experts has voted in favor of a leukemia treatment which could be the first gene therapy available in the U.S.

The Food and Drug Administration advisory panel voted 10-0 on Wednesday to recommend approval of the treatment developed by the University of Pennsylvania and Novartis Corp. The one-time treatment would be for children and young adults with advanced leukemia.

The therapy could be the first of a wave of treatments custom-made to target a patient's cancer. Called CAR-T, it involves removing immune cells from a patients' blood, reprogramming them to create an army of cells to recognize and destroy cancer and injecting them back into the patient.

The FDA is not required to follow the panel's recommendation but often does.

Cancer experts who advise government regulators are reviewing what could be the first gene therapy approved in the U.S.

The Food and Drug Administration panel is holding a hearing Wednesday to discuss the treatment developed by the University of Pennsylvania and Novartis Corp. The drugmaker is seeking approval to use the one-time treatment for children and young adults with advanced leukemia.

The therapy could be the first of a wave of cancer treatments custom-made to target a patient's cancer. Called CAR-T, it involves removing immune cells from a patients' blood, reprogramming them to create an army of attack cells and putting them back into the patient.

The panel is reviewing the safety, effectiveness and production of the treatment. It will vote on whether to recommend FDA approval.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

Comments

Watchlist

Symbol Last Price Change % Change
AAPL

     
AMZN

     
HD

     
JPM

     
IBM

     
BA

     
WMT

     
DIS

     
XOM

     

What Is Petrolithium?

MGX Minerals explains the advantages of petrolithium and how they are helping to solve future problems today.