Gilead Sciences ( GILD ) jumped early Thursday after the Food and Drug Administration approved what is known as a CAR-T drug, dubbed Yescarta, to treat an aggressive form of non-Hodgkin lymphoma. Each treatment of the T-cell therapy is customized using a patient's own immune cells, starting with T cells collection via apheresis, shipment to a manufacturing facility, and genetic modification of the cells to express a vehicle specific to CD19, which is commonly over-expressed in B cell malignancies allowing the modified immune cell to target and kill the lymphoma cell. The immune T-cells are extracted from patients, genetically fiddled to home in on an destroy cancerous cells, multiplied in a lab, and then jolted back into the patient's body within about two weeks.
"Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients", David Chang, MD, PhD, Worldwide Head of Research and Development and Chief Medical Officer at Kite, said in a statement. The FDA is requiring Kite to do a long-term safety study and train hospitals to quickly spot and handle those reactions. Because treatment with this therapy can potentially cause severe side effects, FDA's approval carries a boxed warning for cytokine release syndrome (CRS), a systemic response to the activation and proliferation of CAR-T cells that can cause high fever and flu-like symptoms. At a 6-month analysis, 80% of patients treated with axi-cel remained alive. The Novartis gene therapy was approved in August for B-cell acute lymphoblastic leukemia, the most common form of childhood cancer in the United States.
The market capitalization of Gilead is now reeling at 104.65B based on its aggregate value over its current share price and the total amount of outstanding stocks. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. "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", FDA commissioner Dr. Scott Gottlieb said. Other side effects include infections, low blood cell counts, and dampened immune system.
For more on what role pharmacists can play for patients with lymphoma, view the video below.
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"We believe this is only the beginning for CAR-T therapies", said Arie Belldegrun, MD, FACS, the founder of the Gilead subsidiary, Kite, that won the approval.
The manufacturing site has capacity to produce volumes of the autologous therapy for 4,000-5,000 patients per year, but now Yescarta has been approved Gilead said it is looking to ramp up the number of clinics available to administer the therapy.
Almgren said the approval of Yescarta is "certainly very exciting".
Dr. Fred Locke, an oncologist and researcher at Moffitt Cancer Institute in Tampa, Florida, estimates that there are more than 10,000 adults who might benefit from these treatments, whereas the pediatric approval was initial geared for only about 600 patients a year.