New era for cell therapy as FDA OKs first for solid tumours

pharmaphorum February 18, 2024
Phil Taylor

Iovance Biotherapeutics has carved out a piece of biotech history, becoming the first company to win FDA clearance for a cell therapy used to treat a solid tumour.

The US regulator has granted accelerated approval for Iovance’s autologous tumour-infiltrating lymphocyte (TIL) therapy Amtagvi (lifileucel) to treat patients with melanoma that has spread to other parts of the body but cannot be treated using surgery, who have been previously treated with other therapies including a PD-1 inhibitor.

Targeted treatment with BRAF or MEK inhibitors should also be tried first for patients whose tumours carry BRAF V600 mutations, according to the FDA.

Iovance is hoping to replicate the clinical successes and commercial success seen with CAR-T cell therapies for haematological cancers like...

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