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Novartis Gains FDA Approval for Follicular Lymphoma Cell Therapy
FDA issued accelerated approval for Kymriah after the drug achieved an 86% response rate in phase II clinical trials.
Novartis’s Kymriah was granted accelerated FDA approval last week after the drug’s clinical trial results demonstrated an 86% overall response rate and a high level of safety. Patients with relapsing forms of follicular lymphoma whose cancer resisted other therapies were successfully treated with Kymriah, and 68% achieved complete response.
Ninety patients were included in the trial with a median follow-up period of 17 months. The most severe side effect, high-grade neurological events, was seen in only 6% of patients.
The clinical trial also demonstrated Kymriah’s ability to treat high-risk patients, including those that were heavily pretreated. “The approval of Kymriah offers patients with relapsed or refractory follicular lymphoma a new treatment option and new hope for improving patient outcomes,” said Meghan Gutierrez, Chief Executive Officer at the Lymphoma Research Foundation. “Having this single infusion treatment option helps transform how healthcare providers approach this type of blood cancer.”
This is Kymriah’s third approved indication, and it makes the drug the only chimeric antigen receptor T-cell (CAR-T) therapy approved for both adults and pediatric patients.
Since 2017, several innovative scientific studies have proved the efficacy of CAR-T therapy in the treatment of relapsing liquid tumors. Otherwise challenging to treat tumors are now being controlled with these therapies, contributing years to patients’ lives.
CAR-T cell therapy is a process where clinicians modify normal T cells and infuse them into patients to target cancers. Currently, it is mainly used to treat blood cancers. These cell therapies are a popular industry product, and pharmaceutical companies including Kite, CRISPR, J&J, BMS, and others have all begun to develop the drugs recently.
Pharmaceutical companies charge a high premium for this new class of drug — list prices for treatment involving CAR-T therapy range anywhere from $373,000 to $475,000. Current costs also represent the number of other medications administered alongside therapies and prophylactic drugs that pharmacies must acquire before distributing CAR-T treatments. According to Medicare fee-for-service data, the number of CAR-T claims doubles every six months.
Approximately 15,000 – 20,000 people are diagnosed with follicular lymphoma every year, making it a rare disease in the United States. Most people affected by the disease are over the age of 60, and symptoms are often hard to catch before the disease has progressed into its later stages. This also contributes to the unremitting nature of the disease. Currently, the median survivorship for a person diagnosed with follicular lymphoma is 10–12 years.
