The American Food and Drug Administration (FDA) has just approved the top cancer therapy
This Wednesday the FDA approved Novartis's Kymriah, a pediatric acute lymphoblastic leukemia therapy
"I think this is the most exciting thing I've ever seen in life," said Dr. Tim Cripe, an oncologist and advisory board member of the FDA who voted for this drug in July.
Highly personalized treatment is called CAR T-cell therapy. It's a type of cancer immunotherapy – or a therapy that uses a body's immune system to fight cancer cells.
"We are entering a new era of innovation in medicine with the ability to reprogram patient cells in a way to attack lethal cancer," said FDA commissioner Scott Gottlieb in a statement.
"New technologies such as gene and cell therapy promote the potential for transformation of medicine and create the point of change in our ability to treat many non-communicable diseases. We are committed to the FDA's dedication to speed up the development and review of revolutionary treatments that can potentially save lives. "
CAR-T therapy takes the patient's T-cells, removes them from the body, alternates in the laboratory by adding special receptors to their surface called CAR (19459006) chimeric antigen receptor ) and returns them back to body where modified cancer cells attack.
Therapy, a patent by Novartis, a multinational pharmaceutical corporation based in Switzerland, represents a revolution in the treatment of blood cancer and is likely to be approved by the end of this year
FDA Approves Another CAR-T Therapy by Public Enterprise Kite Pharma, purchased by American Gilead Sciences. This therapy attacks aggressive B-cells of the non-Hodgkin type lymphoid (broader concept of DLBCL). Data reported by Kite in February say that out of 101 patients, 36 percent had complete response to treatment after six months.
This is the type of cancer Novartis wants to get approval sometime in the future.
Novartis released data from the second phase of CTL019 testing in patients with diffuse B lymphoma (DLBCL) large B-cell, aggressive lymphoma, which is just one of two types in Kite Pharma data. Testing showed that out of 51 patients with DLBCL, 23 had complete response (meaning cancer disappeared completely), or partial response (tumor decreased).
Several challenges stand in the way of new therapies like Kymriah:
– This treatment will not be cheap. If the company monetized the drug depending on how successful it is, the price would still be over $ 300,000
– Drug production is not a small undertaking, as personalized therapy requires extracting, reprogramming and restoring cells to the patient's body. Companies that can do this quickly and safely could benefit from this CAR-T competitive area.
– Such treatments were known to be deadly. Kite Pharma announced in May that one person died during a clinical trial at the late stage of CAR-T brain edema therapy, where excess fluid causes brain swelling. In July last year, Juno Therapeutics, another developer of CAR-T therapy, said four people died during clinical trials, all from brain edema.