SOUTH SAN FRANCISCO (dpa-AFX) - Latest approvals by the U.S. Food and Drug Administration include Iovance Biotherapeutics Inc.'s Amtagvi - the first cellular therapy indicated for the treatment of unresectable or metastatic melanoma, as well as Genentech's Xolair- the first medication to help reduce allergic reactions to multiple foods after accidental exposure.
Iovance Biotherapeutics' Amtagvi has been approved to treat adult patients with a type of skin cancer, melanoma, which cannot be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies.
Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light that can come from sunlight or indoor tanning. Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal.
Amtagvi, approved through FDA's Accelerated Approval pathway, is a tumor-derived autologous T cell immunotherapy composed of a patient's own T cells, a type of cell that helps the immune system fight cancer.
This is the first FDA-approved tumor-derived T cell immunotherapy.
Amtagvi's safety and effectiveness was evaluated in a global, multicenter, multicohort clinical study including adult patients with unresectable or metastatic melanoma who had previously been treated with at least one systemic therapy.
Amtagvi also received Orphan Drug, Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review designations. The FDA noted that a confirmatory trial is ongoing to verify Amtagvi's clinical benefit.
Further, Genentech's Xolair (omalizumab) injection has been approved for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I). These include reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods.
Xolair binds to immunoglobulin E or IgE, the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors.
Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
The drug is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.
Xolair's safety and efficacy in reducing allergic reactions was established in one multi-center, double-blind, placebo-controlled study of 168 pediatric and adult subjects who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut or walnut.
The drug was originally approved in 2003 to treat moderate to severe persistent allergic asthma in certain patients, and also for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.
Xolair received Priority Review and Breakthrough Therapy designations for the latest indication.
Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA's Center for Drug Evaluation and Research, said, 'This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies. While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.'
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