Second PARP inhibitor approved by FDA (but still not for prostate cancer)


A second PARP inhibitor has recently been approved by the US Food and Drug Administration (FDA) for the treatment of patients with BRCA1/2 mutations and advanced ovarian cancer who have already received two types of chemotherapy.

It should be noted that, as yet, no poly (ADP-ribose) polymerase (PARP) inhibitor has been approved for the treatment of patients with BRCA1/2 mutations and advanced prostate cancer, but there are data suggesting that the  PARP inhibitors have activity in the treatment of such patients. We are aware of further research in this area (see below), with the possibility of an approval of one or more PARP inhibitors for at least a subset of patients with BRCA1/2 mutations and advanced prostate cancer at some point in the future.

The new PARP inhibitor recently approved is a drug known as rucaparib (Rubraca™), which is an oral, small molecule, PARP inhibitor developed by Clovis Oncology, Inc. The other PARP inhibitor already approved for a very similar indication is olaparib (Lynparza™), developed by AstraZeneca.

There is an ongoing Phase II clinical trial of rucaparib in the treatment of metastatic, castration-resistant prostate cancer and homologous recombination gene deficiency (the so-called TRITON2 trial).

There are several ongoing clinical trials involving the use of olaparib in the treatment of metastatic, castration-resistant prostate cancer, including the Phase III PROfound trial.

3 Responses

  1. Clovis and UCSF are in discussion to develop a clinical trial that will include prostate cancer … Answer Cancer Foundation introduced them last year and development continues. Tom Harding and Larry Fong are both on our Advisory Board. My understanding from Tom is that rucaparib is up to seven times more powerful than olaparib.

  2. Dear Rick:

    My understanding is that Clovis has been talking to a lot of people and centers about the further development of this product.

    I think it is also important to note that the “powerfulness” of any drug may be a two-edged sword, for the simple reason that it may also have serious impact on the possible side effects of the drug as well as its activity on the targeted clinical condition.

  3. They have been speaking to many sites, but are still seeking traction. The UCSF discussions have progressed significantly. Obviously the power of the drug is highly integrated with dosing — Clovis seem to think their drug is more effective. I am unqualified to comment.

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