Friday, April 19, 2019

Astellas and SeaGen plan to file BLA in 2019 for enfortumab molecule

Astellas US

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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