The FDA solid tumor bar has been set.
https://www.fiercepharma.com/pharma/fda-approves-iovances-amtagvi-first-cell-therapy-solid-tumor
In a single-arm study, Amtagvi at the now-recommended dosing range shrank tumors in 31.5% of 73 patients who had previously received an anti-PD-1 therapy. After 18.6 months of follow-up, 43.5% of responders had been in remission for more than a year.In a supporting pooled efficacy analysis that included 153 patients, the objective response rate was similar at 31.4%.
Further, 56.3% of responders maintained durable responses at one year. Although not included in the current label, a recent update of the pooled analysis showed that patients lived a median 13.9 months, whereas nearly half of patients were still alive at four years.
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