Gilead Sciences’ Gene Therapy Approved By The FDA

The U.S. Food and Drug Administration has given approval for a new therapy developed by Gilead Sciences-owned Kite Pharma and which is designed to treat a certain kind of lymphoma. This is the second time an approval is being granted for this approach of fighting cancer which is potentially revolutionary.

The therapy will be sold as Yescarta and will be prescribed for treating adults suffering from large B-cell lymphoma, which has proved untreatable with other therapies. According to Gilead Sciences, the list price of Yescarta will be $373,000. Both drugs are referred to as CAR-Ts – chimeric antigen receptor T-cell therapies as they reprogram the immune cells of the body so that they can recognized and consequently attack malignant cells.

High price

The drug will be administered only once to every patient. This is lower than the price Novartis is charging for a similar drug known as Kymriah and which goes for $475,000. Just like Yescarta, Kymriah is a gene therapy that is used to treat a type of childhood cancer.

Due to the high price being charged on CAR-Ts, a debate has been raging over the rising prices of prescription treatments. In the case of Novartis, the pharmaceutical giant said it would only charge patients for Kymriah if there was a positive response within a month following treatment. Gilead Sciences is, however, not applying the same pricing methodology.

“We are in ongoing and active discussions with payers, and we have communicated our openness to considering different solutions that improve patient access,” said a spokesperson for Gilead Sciences, Amy Flood, in an emailed statement.

Gene therapy

According to Flood the $373,000-price tag was set after extensive research had been conducted with cancer centers, private insurers and government agencies involved in offering reimbursements for drug costs. Michael Yee, an analyst is of the view that sales generated by Yescarta could hit $250 million next year. Gilead Sciences estimates that approximately 7,500 lymphoma patients in the United States are eligible to receive CAR-T therapy.

Per estimates from the American Cancer Society, the number of people likely to be diagnosed as having non-Hodgkins lymphoma will be around 72,240. Of these 20,140 will not survive. In the U.S. cases of non-Hodgkins lymphoma are about 4% of all cancers.

The CAR-T therapies are considered potentially revolutionary since they are tailored to an individual patient. These therapies are developed from the infection-fighting cells of the patient. Once these cells are extracted from the patient, they are genetically engineered to make it possible for them to recognize malignant cancer cells. They are then re-infused into the body of the patient to attack and destroy the malignant cancer cells.

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