As expected by those who welcome good news from publicly-traded firms, the Food and Drug Administration (FDA) has given the green light to a second CART immuno-oncology product with the trade name Yescarta. This drug, which has been developed by Kite Pharma is now belonging to Gilead Sciences (GILD) together with the rest of Kite’s CAR T wealthy pipeline after Gilead acquired Kite less than two months ago at $11.9 billion. In addition to CAR T products for blood and lymphatic cancers, Gilead oncology pipeline now comprises CAR T products for both blood and lumph cancers, in addition to solid cancers.
The FDA approved Yescarta for adult patients with non-Hodgkin’s lymphoma, who have been previously unsuccessfully treated with chemotherapy products. Around 3,500 people in the United States are expected to be treated by a single infusion with Yescarta, whose cost will be around $373,000.
The first CAR T to be granted FDA approval is Kymriah (tisagenlecleucel). This CAR T, which belongs to Novartis (NVS), is indicated for refractory and relapsed acute lymphoblastic leukemia (ALL).
The adverse effect known as the cytokine release syndrome is the severest of the CAR T adverse effects. Some patients who developed this side effect had to be treated in intensive care unit. Still the number of patients who were rescued with the CAR T approach from imminent death by the cancer itself overwhelmed by far the number of patients who died from the procedure. Needless to remind that oncologists know now how to better manage this adverse effect through precautionary measures and improved treatment approaches.
Among several precautionary measures, oncologists are now administering the CAR T products in a gradual studied way. In the beginning, approved and marketed CAR T drugs such such as Yescarta and Kymriah will be administered only at medical centers where the team of physicians and nurses have been educated and received training that enables them to properly handle the CAR T drugs, avoiding the adverse effects, or to treat those patients who, regardless of the precautionary measures still develop the cytokine release syndrome.
The approval of Yescarta stands on a study where over 101 patient suffering from either diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or transformed follicular lymphoma received the drug. Around 54% of these condemned patients had complete remissions and 28% had partial remissions. Important to know though that 80 percent of those patients were still alive six months after receiving one infusion and many living the lives they used to live before the cancers hit them.
Dr. Scott Gottlieb, the current Commissioner of the Food and Drug Administration (FDA) said that the FDA. had designated the CAR T treatment a breakthrough and accelerated the approval process so that cancer patients, many of whom do not have time to wait, will get the treatment. Dr. Gottlieb said, “Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases.” the F.D.A. commissioner, Dr. Scott Gottlieb, said in a statement. “In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer.”
Yescarta is expected to be approved for earlier-stage lymphomas. Kite, which is operating from inside Gilead is working hard towards producing cell therapies for solid tumors, which had demonstrated resistance to CAR T treatments.
The news is great for Gilead. The news is also encouraging for firms that specialize in the genetically engineered CAR T treatments, including, Celyad (CYAD), Novartis (NVA), Juno (JUNO), Cellectis (CLLS) and others.
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