J&J expects to file for approval to market two new prostate cancer drugs


An announcement from Johnson & Johnson yesterday said that the company is projecting filings with regulatory authorities for approval of two new drugs for the treatment of advanced prostate cancer between 2017 and 2021.

The two new drugs for treatment of prostate cancer referred to in the company’s press release are:

  • Apalutamide (also known as ARN-509) for the treatment of pre-metastatic prostate cancer
  • Niraparib, which is a PARP inhibitor already approved (under the brand name Zejula) for the treatment of ovarian cancer

In the case of niraparib, The “New” Prostate Cancer InfoLink would expect the initial, potential approval to be for the treatment of a subset of men with metastatic, castration-resistant prostate cancer who also have certain specific types of mutation to the cancerous tissues known as DNA repair anomalies. An ongoing Phase II trial is expected to report data in 2019.

In the case of apalutamide, this drug is being investigated in a variety of Phase III trials in varied clinical settings, as follows:

  • In the treatment of men with non-metastatic, castration-resistant prostate cancer (in the SPARTAN trial)
  • In the treatment of men with high-risk localized and locally advanced prostate cancer, in combination with radiation therapy (in the ATLAS trial)
  • In the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer, in combination with abiraterone acetate and prednisone (see NCT02257736)

Data from both the first and the third of these studies can be expected by the end of 2018. Data from the ATLAS trial will take longer to come to maturity.

2 Responses

  1. As an African American Veteran I am celebrating my success in obtaining the Provenge technology through Medi-Cal, which side-stepped the seemingly hostile and diversionary tactics at the Palo Alto VA Oncology/Urology clinic to keep my PSA rising and slaved to a “standard of care” model that is not only hidden, but maybe non-existent to ensure early death of “selected” veterans!

  2. Congratulations!

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