An advisory committee at the U.S. Food and Drug Administration (FDA) just gave a critical recommendation for pharmaceutical company Novartis’ (NYSE:$NVS) new cancer therapy. The data for the therapy, called CTL019 and developed to treat pediatric acute lymphoblastic leukemia, was presented by Novartis to the advisory committee on Wednesday, July 12. The committee then voted unanimously — all members were in favor of the treatment.
Novartis’ treatment is centered around CAR T-cell therapy, a type of cancer immunotherapy that uses specific cells in the patient’s immune system to help eliminate cancer cells. More specifically, the treatment removes a person’s own cells from their body and then the cells get re-engineered and put back into the body where they can attack cancer cells. Novartis’ CAR T-cell therapy is one of the two cutting-edge blood cancer treatments that are set to get approved by the FDA by the end of 2017.
However, while the advisory committee gave an overwhelmingly positive recommendation of the drug and the FDA can take the recommendation into consideration, actual FDA approval won’t necessarily have the same results. According to Bloomberg, a decision should be reached by the FDA and informed to Novartis by October 2017.
The following month, on November 2017, the other pharmaceutical company with a cutting-edge blood cancer treatment — Kite Pharma (NASDAQ:$KITE) — will be getting an answer from the FDA on its CAR-T treatment. Kite’s CAR T-cell therapy is aimed to treat aggressive B-cell non-Hodgkin lymphoma. Data released by Kite Pharma back in February showed that out of 101 patients, 36%, or about 40 patients, responded completely to the treatment after just six months. Kite is now one of Novartis’ biggest competitors when it comes to the CAR-T treatment space.
Treatment for B-cell non-Hodgkin lymphoma is something that Novartis is also aiming at. Novartis reported data from the Phase 2 trial of CTL019, treating patients with diffuse large B-cell lymphoma (DLBCL), in June. The condition is one of the two types of B-cell lymphoma that Kite’s data considered back in February. Novartis’ trial showed that 23 out of 51 patients with DLBCL had either a complete response or partial response to their treatment.
Despite being close to gaining FDA approval, both Novartis and Kite still face a number of challenges regarding these new cutting-edge cancer treatments:
These treatments won’t be cheap — the price for the therapy could cost up to and even more than $300,000. Affordability will be a big issue for patients.
The treatment — due to the complex procedure of taking out someone’s cell, reprogramming it, and putting it back in the body — will be extremely difficult to manufacture. Both Novartis and Kite will have to learn how to do the treatment quickly and safely so that patients can get well instead of getting worse.
CAR-T therapy can be unpredictable and deadly. Back in May, Kite Pharma disclosed that one of their patients had died in its clinical trial for late-stage CAR-T therapy. The patient passed away from cerebral edema, a condition that causes the brain to swell from excessive fluid.
Another pharmaceutical company with a focus on CAR-T therapy, Juno Therapeutics (NASDAQ:$JUNO) revealed that four patients had died from its clinical trials, all due to cerebral edema.
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