@gently And the EMA approved Provenge for the EU in 2013. Then, unfortunately, the company Dendreon filed for Chapter 11 bankruptcy in 2014, and as part of their reorganisation, decided not to pursue the European market.

Part of the problem was that Provenge extended survival (vs placebo) but not progression-free survival: it kept patients alive longer, but didn't do anything to slow down the cancer. Shortly after Provenge came out, the first -lutamide (Enzalutamide) also came out, which extended both survival *and* progression-free survival — reducing PSA and often shrinking tumours — and -lutamides are simple, shelf-stable pills that can be shipped around the world at room temperature, while Provenge requires extracting T-cells, shipping them to a central facility (which would have had to be built in the Europe), and getting them back to the patient, all within a 48-hour window.

I suspect Dendreon rightly judged that EU countries simply wouldn't be interested in a treatment that cost €75K+, required infrastructure comparable to organ transplants, and was less-effective than pills. There are also other escalations available if ARSIs like the lutamides stop controlling the cancer (e.g. Pluvicto).

(FWIW, Health Canada never approved Provenge either, though Canada does support immunotherapies like CAR-T for other cancers, because there's good evidence that they provide an additional benefit.)