Kite Pharma conducted a multicenter clinical trial involving 101 adults with relapsed large B-cell lymphoma to convince the FDA to give the therapy its approval. "Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients", said David Chang, Worldwide Head of Research and Development and Chief Medical Officer at Kite. In some cases the treatments have led to long remissions.
The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Currently, patients with large B-cell lymphoma in second or later lines of therapy have poor outcomes and greater unmet need, since almost half of them either do not respond or relapse shortly after transplant. These can include life-endangering neurologic toxicities - with symptoms of headache, limb numbness, loss of memory, vision, and/or intellect - and cytokine release syndrome, when a storm of immune proteins called cytokines are released into a patient's circulatory system.
It's a little different from similar approaches in which a cancer patient's immune cells are harvested and numbers boosted in the lab.
The new drug is made by California-based Kite, a subsidiary of drug giant Gilead Sciences that develops chimeric antigen receptor and T-cell receptor (CAR-T) cell therapies.
If you were to assign an all-in acceptance for Yescarta with 100% of the patients, that would generate close to $2.8 billion at the listed price from the full 100% patients per year.
Three-quarters of the total insect population lost in protected nature reserves
Yet, this dramatic decline has occurred'. "Farmland has very little to offer for any wild creature", said Goulson. Insects play an important role in pollinating plants and are a source of food for birds, mammals and amphibians.
The drug was approved along with a risk evaluation strategy that requires hospitals and clinics that prescribe the drug to be specially certified and trained. The tumors in 72 percent of the test subjects shrunk and even disappeared completely in 51 percent of the subjects. In addition, the packaging must include a warning to alert patients of the risks.
Gottlieb added that the FDA "will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine".
On Wednesday-for only the second time-the Food and Drug Administration approved a cutting-edge therapy that genetically modifies a patient's blood cells in order to attack cancer.
"We believe this is only the beginning for vehicle T therapies", Arie Belldegrun, MD, FACS, founder of Kite, said in a statement. Several other companies also have CAR-T therapies in the works.
"This is just the beginning of using cellular therapies in oncology so every new approval is an important step toward the future of care", Brad Loncar, CEO of Loncar Investments, said in a Twitter tweet yesterday at 5:55 p.m.