FDA award Clovis’ prostate cancer treatment Breakthrough Therapy status
Clovis Oncology’s Rucaparib has been designated as a Breakthrough Therapy by the FDA in prostate cancer, paving the way for a faster review if clinical trials achieves favourable results.
The FDA has said that phase 2 data suggest the drug could represent a new therapy option for men whose cancer has progressed despite chemotherapy, and treatment with androgen receptor therapy such as Pfizer/Astellas’ enzalutamide, or Johnson & Johnson’s abiraterone.
Already approved in ovarian cancer, Boulder, Colorado-based Clovis is developing Rucaparib as potential therapy for prostate cancer.
Rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, works differently from already approved prostate cancer drugs – it does not target antigen receptors, instead causing cancer cells to self-destruct by inhibiting their ability to fix damaged DNA.
The latest Breakthrough Therapy designation for Rucaparib was granted based on initial efficacy and safety results from TRITON2, a phase 2 study in men with advanced prostate cancer with BRCA 1/2 mutations (germline or somatic) and deleterious mutations in other homologous recombination repair genes, in metastatic castration-resistant patients.
Initial data from the TRITON2 study will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place later this month in Munich.
Clovis is also testing Rucaparib against Enzalutamide and Abiraterone in a phase 3 trial that could potentially allow the drug to be used in patients in earlier stages of the disease, and compete directly with these established drugs.
AstraZeneca was the first company to get a PARP inhibitor approved, and with Merck & Co is developing olaparib in prostate cancer, and is targeting a filing and Breakthrough Therapy designation next year.
Pfizer is also developing its talazoparib PARP drug, acquired along with cancer drug biotech Medivation in 2016, in first- and second-line prostate cancer.
Patrick Mahaffy, president and CEO of Clovis Oncology, said: “We are committed to the rapid development of Rucaparib in mCRPC and we are obviously pleased to receive Breakthrough Therapy designation. We look forward to presenting the data that served as the basis of our BTD application at the ESMO conference later this month.
“We hope the decision by the FDA to grant this Breakthrough Therapy designation for Rucaparib offers encouragement to the prostate cancer community, and we will do our best to make Rucaparib available to eligible prostate cancer patients as quickly as possible.”