Iovance shares hammered on TIL therapy filing delay — although analysts aren't as bothered
Iovance won’t be able to file for its first-ever approval by the end of this year after all.
At issue is the potency assays Iovance is using to define what would be the first-ever tumor-infiltrating lymphocyte (TIL) therapy. Regulators want to have more data on the current assays, or potentially see different assays in the BLA, the biotech suggested.
All of that work would push the BLA submission in metastatic melanoma to 2021, when Iovance has completed the required clinical follow-up and finished refining its assays as well as developing alternative ones. That means a launch won’t happen until 2022 at the earliest, with cervical cancer to follow in the same year.
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