J&J to seek approval of apalutamide in treatment of mCSPC

According to a media release issued yesterday by Johnson & Johnson, its Janssen Pharmaceuticals division has just submitted an application to the U.S. Food and Drug Administration for the approval of apalutamide (Eleada) in the treatment of men with metastatic, castration-sensitive prostate cancer (mCSPC).

This application is based on data from the Phase III TRITON clinical trial, which had enrolled > 1,050 patients with mCSPC who were randomized to treatment with either apalutamide + androgen deprivation therapy (ADT), or a placebo plus ADT.

The media release goes on to state that the core results of this trial will be presented at the upcoming meeting of the American Society of Clinical Oncology (ASCO) in late May or early June.

At the present time, apalutamide is approved exclusively in the US for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC). Should this approval be granted by the FDA, it would allow for apalutamide to be used in a different patient population. What is yet to be shown is whether the level of effectiveness of apalutamide + ADT in this patient population might be superior to that of other, currently approved forms of therapy (e.g., ADT + docetaxel and ADT + abiraterone acetate).

3 Responses

  1. It would be really interesting in this regard to trial monotherapy apalutamide. We have discussed this with Janssen.

  2. I read your comment “approved exclusively in the US for …” and wondered why not other countries and then I thought you meant “approved in the US exclusively for…” which I think is what you meant.

    The indication is exclusive and not the US location as exclusive. Please clarify.

  3. Dear Tarhoosier:

    Apalutamide has been approved in both the US (on February 14, 2018) and the European Union (the latter as of March 19 this year) for the treatment of nmCRPC. However, …

    In most European countries, to date, apalutamide is only available if one pays for it oneself because organizations like NICE in the UK and its equivalents in other nations such as IWIG in Germany) are still assessing the cost-benefit ratio of treatment with this drug and negotiating the pricing with the manufacturer.

    I believe (but haven’t seen confirmatory data) that the same is true in places like Australia and New Zealand. The situation in Canada varies from province to province.

    Thus, to a large extent, even though apalutamide has been formally approved for use in the EU, the US is the only country in which apalutamide is currently widely and easily available for the treatment of nmCRPC for the majority of patients (because Medicare is required by law to cover the costs of any drug approved by the FDA for the treatment of cancer).

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