
Astellas and SeaGen are moving forward on their enfortumab currently in Phase II clinical trials. They have seen an overall response rate of 44% for patients previously unresponsive to a chemo + checkpoint inhibitor therapy.
They believe that these topline data are significant enough for a BLA application filed later in 2019 concurrent with Phase III trials for global registration.
Given the cost of these therapies, is there any limit to the size of a population where the therapy would not be worth the cost? As it appears the answer is no, what is the long game on this?
https://www.fiercebiotech.com/biotech/astellas-seattle-plan-fda-filing-after-cancer-adc-clears-test
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