A closer look at BRCA mutations in advanced ovarian cancer
Key differences between germline and somatic BRCA mutations1-4
|Origin of mutation||Inherited||Acquired|
|Location of mutation||Found in all cells in the body||Found only in tumor cells|
Testing of BRCA mutations
Rubraca is indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Testing tumor DNA for BRCA mutations may identify patients who may benefit from PARP inhibition1,2,5,6
- In clinical trials of Rubraca, BRCA mutation status was determined using the FoundationFocus™ CDxBRCA test
- Archived tumor tissue can be used to test for both germline and somatic mutations
1. Pennington KP, Walsh T, Harrell MI, et al. Clin Cancer Res. 2014;20(3):764-775. 2. Robson ME, Bradbury AR, Arun B, et al. J Clin Oncol. 2015;33(31):3660-3667. 3. Hennessy BTJ, Timms KM, Carey MS, et al. J Clin Oncol. 2010;28(22):3570-3576. 4. Petrucelli N, Daly MB, Feldman GL. BRCA1 and BRCA2 hereditary breast and ovarian cancer. 1998 Sep 4 [Updated 2013 Sep 26]. In: Pagon RA, Adam MP, Ardinger HH, et al, editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2016. 5. Mafficini A, Simbolo M, Parisi A, et al. Oncotarget. 2016;7(2):1076-1083. 6. Watkins JA, Irshad S, Grigoriadis A, et al. Breast Cancer Res. 2014;16(3):211.