FDA awards accelerated approval to Clovis' Rubraca for ovarian cancer

The FDA on Monday granted accelerated approval to Clovis Oncology's PARP inhibitor Rubraca (rucaparib) to treat advanced ovarian cancer in women who previously received two or more chemotherapies and whose tumours have a BRCA gene mutation. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, noted that the "approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient's genes." 

The agency said the decision was supported by data from two single-arm clinical trials involving 106 patients with BRCA-mutated advanced ovarian cancer who had received at least two chemotherapy regimens. Results from the studies, which were disclosed in October, demonstrated that 54 percent of Rubraca-treated patients experienced partial or complete tumour shrinkage, with the effect persisting for a median of 9.2 months (for related analysis, see ViewPoints: New rucaparib data prick hole in Clovis' M&A-fuelled valuation – bargain buy or caveat emptor?)

FirstWord Reports: Providing insight, analysis and expert opinion on important Pharma trends and challenging issues <Click here>

The FDA also approved Foundation Medicine's FoundationFocus CDxBRCA companion diagnostic for use together with Rubraca. The agency noted that the test, based on next-generation sequencing, uncovers the presence of deleterious BRCA gene mutations in the tumour tissue of patients with ovarian cancer to help identify those who may be suitable for treatment with Rubraca. 

To read more Top Story articles, click here.