(USA)
A game-changing cancer therapy has taken a major step to becoming commercially available after an expert American panel voted unanimously in its favour.
By 10 to 0, the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee gave its backing for what is a revolutionary treatment targeted at a specific type of leukaemia: B-cell acute lymphoblastic leukemia (ALL). Called CTL019, the therapy genetically changes the cells of a cancer patient to enable them to combat the disease. Developed by Novartis, working with the University of Pennsylvania and Oxford BioMedica, it will – if passed by the FDA later in the year – be the first ever gene therapy to make it to market.
One injection transformed the life of Emily Whitehead (pictured below centre) during trials. Doctors had given up hope on Emily – who had been put into hospice care. That was more than five years ago. Emily is now a fit and healthy 12-year-old thanks to CTL019.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “The positive vote by 10 to 0 provides further support for CTL019, a novel immunocellular therapy, and we are proud to be a part of this important development. We continue to work closely with Novartis in delivering the lentiviral vector that encodes CTL019, a product the company described earlier this year as having “blockbuster” potential.”
Dr John Maris, a pediatric oncologist at The Children’s Hospital of Philadelphia, added: “When fully commercialised, this therapy will no doubt save the lives of many children and young adults who have had no other effective therapy for relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). This is truly a turning point in the management of this disease.”
Novartis will seek full FDA approval this year, with filings also scheduled with the EU.
