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Worldwide Clinical Trials - Oncology

Moffitt Cancer Center achieves a milestone as FDA approves groundbreaking Tumor-Infiltrating Lymphocyte Therapy for advanced melanoma

The recent approval by the Food and Drug Administration (FDA) of a novel cellular immunotherapy at Moffitt Cancer Center marks a pivotal moment for patients battling advanced melanoma. This groundbreaking therapy, known as lifileucel, represents the first FDA-approved tumor-infiltrating lymphocyte (TIL) treatment for solid tumors. TIL therapy capitalizes on the body's immune system to identify and combat cancer cells.

In the process, melanoma tumors are surgically excised and transported to a specialized facility for extraction of tumor-infiltrating lymphocytes. These immune cells are then cultured and expanded to large quantities. To accommodate the influx of these immune cells, patients undergo chemotherapy to temporarily suppress their immune system before receiving the TIL infusion. From tumor removal to infusion, the entire procedure typically spans six to twelve weeks.

The FDA's approval of TIL therapy signifies a groundbreaking advancement, paving the way for a new era of T-cell immunotherapies. Researchers are not only investigating ways to enhance TIL therapy production and efficacy but also exploring the optimal timing for treatment to maximize patient outcomes. Additionally, Moffitt Cancer Center is extending its research to apply TIL therapy to other solid tumor types, including lung, sarcoma, cervical, and bladder cancers.

This milestone approval provides hope and encouragement for further advancements in T-cell therapeutics, inspiring continued investment and innovation in cancer treatment.

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