Novartis AG (ADR) (NYSE:NVS) has revealed that CTL019 has been granted a priority review designation by the U.S. Food and Drug Administration. This follows a BLA (Biologics License Application) that Novartis had lodged for the drug. CTL019 is a drug developed for the treatment of acute lymphoblastic leukemia.
The application from Novartis sought to have CTL019 used as a therapy to treat refractory and relapse pediatric patients suffering from B-cell lymphoblastic leukemia. Besides pediatric patients, the drug could also be used to treat young patients. In a relapse, patients experience improvement only for the disease to return or for the condition to deteriorate. A refractory, on the other hand, is a situation where a patient is not responding well to any form of treatment.
Shorter review period
With a priority review designation, the period of drug review can be shortened by four months from the standard ten months to half a year. Accompanying the Biologics License Application is clinical data from the phase 2 trial which demonstrates that 82% of the participants who received CAR-T cells were able to go into complete remission or at least complete remission but with blood count recovery that was incomplete after three months had elapsed following treatment. In a situation where there is complete remission, scans, physical exams and tests demonstrate that all cancer signs have disappeared.
CAR-T Therapy
This will be the first regulatory submission made by Novartis with regards to a therapy that is CAR-T-based. With the therapy that is based on CAR-T, immune system cells are extracted from the body of the patient and then are fabricated in a genetic process with a view to identifying cancer. The immune system cells are then later infused back into the body of the patient to fight cancer.
In a study conducted by Novartis in 2015, this therapy process demonstrated high success rates in a certain blood cancer as in 93% of the cases involving young adults and children, the cancer was eliminated. But as highly effective as the method is, it has severe adverse effects and complications.
On Thursday shares of Novartis AG fell by 0.12% to close the day at $74.76.