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Groups Seek More FDA Flexibility in Early Cell Therapy Development

A new white paper from the Friends of Cancer Research (FOCR) and the Parker Institute for Cancer Immunotherapy calls on the US Food and Drug Administration (FDA) to ease clinical and manufacturing requirements to speed early development of anti-cancer cell therapies.

In recent years cell therapies, including engineered T-cell receptor (TCR) and chimeric antigen receptor (CAR) T-cell therapies have shown promise in treating a wide range of cancers. To date, FDA has approved two CAR T-cell therapies to treat specific hematologic malignancies.

“To potentially help a much larger number of patients, in particular those patients with solid tumors and no remaining treatment options, it would be desirable to advance small, data-intensive clinical exploratory studies to differentiate which approaches warrant further focus,” the groups write, noting that solid tumors account for 90% of cancer cases.

Following typical IND requirements, the groups argue, limits the study of investigational T-cell therapies to a “select few product candidates.”

Specifically, the paper calls for FDA to revise its 2006 guidance on exploratory investigational new drug (IND) studies to provide recommendations for exploratory studies of cell therapies.

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