FDA approves apalutamide for treatment of nmCRPC


Yesterday afternoon the US Food & Drug Administration (FDA) approved apalutamide — which will have the brand name Erleada — for the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC).

This approval is based on the data from the SPARTAN trial which were presented less than a week ago at the Genitourinary Cancers Symposium in San Francisco and published in the New England Journal of Medicine.

While the results of the SPARTAN trial appear to be impressive at first sight, The “New” Prostate Cancer Link would warn the prostate cancer patient community that there is still a great deal that we do not know about the practical clinical value of apalutamide in the management of nmCRPC. Here are just a couple of the more obvious examples:

  • We don’t know if it can provide a true, overall survival benefit.
  • We don’t know the seriousness of its side effect profile in routine clinical practice (but we do know that rashes, hypothyroidism, and fractures were significantly more common in patients treated with this drug as compared to a placebo).

And then there is going to be the cost, which (as far as we can tell) is still to be formally announced. The one thing we can feel fairly sure about is that it will be relatively high, i.e., similar to that of enzalutamide (Xtandi), which according to GoodRx is > $12,000 for 120 tablets (a 1-month supply).

There would seem to be little doubt that enzalutamide will also get approved relatively soon for exactly the same indication, based on the results of the PROSPER trial, which were also presented at the same Genitourinary Cancers Symposium last week, and which were closely analogous to the data from the SPARTAN trial.

So the one thing that we can be quite sure of is that the prostate cancer marketing battles (between Astellas and Pfizer on the one hand and Johnson & Johnson on the other) will be continuing for many years to come as the companies seek to persuade physicians and their patients that one of these drugs is “better” than the other in the treatment of nmCRPC.

Approval of apalutamide by the European Union and other countries around the world can be expected in the relatively near future, but whether the use of this drug will be accepted on cost-effectiveness grounds by the National Institute for Health and Care Excellence (NICE) in England and by similar decision-making bodies in other countries will be a whole other question to be resolved.

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