FDA gives priority review status to NDA for apalutamide


Apparently the US Food and Drug Administration (FDA) will give a priority review to apalutamide (formerly known as ARN-509), based on data from the Phase III SPARTAN  trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC). This information comes from a media release issued yesterday by Janssen Biotech (a division of Johnson & Johnson).

The implication of a priority review is that the FDA will make a decision about the approvability of apalutamide on or before about April 10, 2018, i.e., 6 months from the time of receipt and acceptance of the new drug application (NDA) by the FDA.

The media release also advises us that, as expected, an oral presentation at the upcoming Genitourinary Cancers Symposium in early February 2018 will provide a full report on the results of the SPARTAN trial. Earlier this year, Janssen had announced positive results from the SPARTAN trial.

As has been noted several times before, there are currently no approved drugs for the treatment of nmCRPC. Hopefully, we will soon have two such drugs: enzalutamide (Xtandi) and apalutamide.

3 Responses

  1. “Non-metastatic castration-resistant prostate cancer (nmCRPC)” impies that the PSA is going up but that there are no detectable lesions on scans. The cancer must be somewhere so it is probably just not detectable by our current technology.

    That said, the story is encouraging since many of us have seen these new drugs get to market while we have been getting treated and will benefit hopefully from some.

  2. I understand the key feature of ARN-509 to be that it works for men who are AR V7 positive!

  3. Dear Rick:

    I think it is probably more accurate to say that ARN-509 may work against some men who are AR V7 positive. I am not aware of any definitive data on the effectiveness of apalutamide in treatment of men who are known to be AR V7 positive.

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