FDA approves first PARP inhibitor for selected men with mCRPC

Yesterday evening the US Food and Drug Administration (FDA) approved rucaparib (Rubraca) for the treatment of men with BRCA1/2-mutant, metastatic, castration-resistant prostate cancer (mCRPC) who have also already been treated with androgen receptor-directed therapy and taxane-based chemotherapy.

This is obviously a limited indication for this drug in the treatment of very advanced prostate cancer, but some payers may be willing to cover the costs of an agent like this off-label when, for example, the patient has either

  • BRCA1/2-mutant mCRPC that has already been treated with androgen receptor-directed therapy but not with taxane-based chemotherapy or
  • BRCA1/2-mutant, non-metastatic CRPC who have also already been treated with androgen receptor-directed therapy and taxane-based chemotherapy

The complete media release from Clovis Oncology can be found on line, here, and numerous other sources have also covered this news.

We expect other PARP inhibitors to receive similar, limited indications for the treatment of advanced forms of prostate cancer in 2020. The most important questions still to be answered are:

  • Is there a true overall survival benefit associated with treatment of a subset of patients with PARP inhibition (as opposed to a progression-free survival benefit)?
  • Is there a benefit to longer-term maintenance therapy with PARP inhibition for prostate cancer patients who respond to initial therapy with a PARP inhibitor?
  • Is there a benefit to earlier treatment of progressive prostate cancer among men with BRCA1/2-mutant prostate cancer? For example, can appropriately selected patients be treated early with some combination of androgen deprivation therapy (ADT) and a PARP inhibitor as soon as they progress after standard forms of treatment for localized or locally advanced disease?
  • Should any man initially diagnosed with lymph node-positive or metastatic BRCA1/2-mutant prostate cancer receive a PARP inhibitor in association with other forms of treatment (e.g., ADT and/or taxane chemotherapy)?

We still have a long way to go before all the questions like this can be answered. However, we now have the first approval of a whole new class of agents for the treatment of prostate cancer. This in and of itself is excellent news.


One Response

  1. Anecdotally, AnCan can claim a minor role in this approval!

    5 years ago we were supporting a man in SF, who became a good buddy. He was diagnosed de novo metastatic in his early 50s with young kids, and had horrible disease. Trevor lasted just 11 months! He had been in the US 30 years but sounded like he had just stepped of the boat from County Limerick.

    Trevor had a friend through his kids’ school, a Brit called Tom Harding who was the Senior VP of Research at Clovis Oncology. I introduced Tom to Larry Fong as Clovis had been having trouble finding a good entry point to UCSF. Out of that grew the TRITON2 trial, of which Chuck Ryan, formerly at UCSF, is a P.I.

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