The Swiss company Novartis has introduced a new drug to treat large B-cell lymphoma, which makes up 30% of lymphoma cases, and the new drug has been given the FDA’s coveted “breakthrough label.” This label means that, because the drug is meant to treat a serious or life-threatening illness, and because it has been shown to be effective in trials, the process for approving it by the FDA has been expedited.
Novartis is in competition with Kite Pharma, a rival pharmaceutical company. Both are in a race to be the first to bring to market the first effective CAR-T anti-cancer treatment. Until now, cancer treatment has been limited to things like, surgery, radiation therapy, and chemotherapy.
An effective CAR-T would instead use the body’s immune system to combat the cancer, and such a drug has been talked about for years. T-cells are extracted from the patient and are genetically modified to produce antigens that will recognize and respond to the cancer, and are then injected back into the patient.
Many think that an effective CAR-T would basically be an actual cure for cancer. The treatment was shown to cause remission rates of 94% in patients with late stage acute lymphoblastic leukemia (ALL), and 80% in all other blood cancers.
The latest drug by Novartis to be approved would actually be the second CAR-T candidate
to receive the breakthrough label. Kite Pharma already has two breakthrough labels on two other lymphoma cancer drugs, and they have another on the way.
The breakthrough label is a gamechanger for any biotech company that receives one, not only because of the work they then get to do, but because it attracts further investment. Investment advisors regard the biotech industry as one of the most risky, but not because there isn’t tremendous growth potential. Forbes calls biotech “one of the last great growth frontiers for retail investors.”
The reason it’s risky is because, as Investopedia proclaims, the FDA is the gatekeeper to drug trials, and it’s “mood” has to always be considered. Researchers, industry leaders, investors, as well as patients, have long regarded the FDA as a barrier rather than an aid.
Other companies, such as TransCelerate, are working to improve the speed and efficiency of drug trials by streamlining the entire process. Its many initiatives include eConsent, which is a simplified standard for test patient consent, and a database known as eSource that is intended to help researchers find existing information easier.
Novartis and Kite Pharma may be on track to provide the world with its most effective weapon against cancer yet. Only time will tell when and how the next breakthrough will come.