Rubraca, a drug initially designed to treat certain forms of ovarian cancer, has just received Breakthrough Therapy designation for advanced prostate malignancy. The drug was previously awarded this classification two other times, once in 2016 and the second just earlier this year, for epithelial ovarian, fallopian tube, or primary peritoneal associated cancers.
“We are committed to the rapid development of Rubraca in mCRPC and we are obviously pleased to receive Breakthrough Therapy designation”, said Patrick J. Mahaffy, President, and CEO of Clovis Oncology, the company producing the medication. The complete data resulting from the trials will be presented at the ESMO conference, later in the month.
The FDA assigns this label in order to “expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)”.
While there isn’t much information about the second phase of the TRITON2 testing program, it seems the focus was “advanced prostate cancer with BRCA 1/2 mutations (germline or somatic) and deleterious mutations of other homologous recombination (HR) repair genes, in the metastatic castration-resistant setting”, according to the press release.
Rubraca is an oral, small molecule that inhibits PARP1, PARP2, and PARP3 enzymes. It is currently being tested on a number of cancers, including some affecting the bladder.
Howard R. Soule, Ph.D., Chief Scientific Officer of the Prostate Cancer Foundation commended the news and added: “In particular, we are enthusiastic about the potential for targeted therapies that may provide more meaningful benefit to patients with specific genetic mutations”.
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