FDA Okays 2nd Gene Therapy for Cancer

FDA Okays 2nd Gene Therapy for Cancer

FDA Okays 2nd Gene Therapy for Cancer

The approval follows a multicenter clinical trial that tested the safety and efficacy of axicabtagene ciloleucel in 100 adults with refractory or relapsed large B-cell lymphoma and observed a complete remission rate of 51%. Axicabtagene ciloleucel is indicated to treat adults with certain types of National Hockey League, including DLBCL, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma, according to the study. "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", said Food and Drug Administration Commissioner Scott Gottlieb in a statement. The technique uses cells from the patient's own immune system to create a custom treatment to help fight the cancer. The first vehicle T treatment to be approved-tisagenlecleucel (Kymriah), developed by Novartis-reported an 83% remission rate within 3 months of treatment in patients with B-cell precursor acute lymphoblastic leukemia.

The approval comes as the FDA is set to offer more guidance to manufacturers on the development of gene therapies similar to Yescarta. The most common one accounts for about a third of the estimated 72,000 new cases of non-Hodgkin lymphoma diagnosed each year.

Noting the FDA's commitment to "supporting and helping expedite" the development of gene therapies, Gottlieb said, "we will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine". This newer drug class is not immune to problems, but it also brings great promise for those patients who struggle to beat cancer.

More precisely, Yescarta is the first vehicle T therapy indicated for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). According to the FDA, potentially serious side effects include cytokine release syndrome (CRS), which can cause high fever and flu-like symptoms, and neurologic toxicities.

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Other potential side effects include serious infections, low blood cell counts and a weakened immune system.

Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center, helped develop the therapy and said the FDA's second approval of a CAR-T cell therapy "validates the revolution underway in the field of cellular immunotherapy". As part of that certification, staff involved in the prescribing, dispensing, or administering of Yescarta are required to be trained to recognize and manage CRS and nervous system toxicities. Hospitals and their associated clinics that dispense axicabtagene ciloleucel must be specially certified. The manufacturer aims to train up to 90 centers about the drug.

On August 30, the FDA approved its first cell-based gene therapy for the treatment of advanced leukemia in children and young adults. In CAR-T therapy for hematologic cancer, a patient's own T cells are engineered to seek and destroy cancer cells.

For more on what role pharmacists can play for patients with lymphoma, view the video below.

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