BRACAnalysis CDx
The inherited BRCA test that decides who can have PARP inhibitor pills for ovarian, breast, pancreatic and prostate cancer.
Overview
Approved 19 December 2014 (PMA P140020) as the companion diagnostic for olaparib in germline BRCA-mutated advanced ovarian cancer, the first FDA-approved companion diagnostic based on an inherited variant. Claims followed for olaparib and talazoparib in HER2-negative metastatic breast cancer (2018), olaparib maintenance in first-line ovarian cancer (SOLO-1, 2018), pancreatic cancer (POLO, 2019), metastatic castration-resistant prostate cancer (PROfound, 2020) and early breast cancer (OlympiA, 2022). Myriad's monopoly on BRCA testing ended with the 2013 US Supreme Court ruling that isolated genes cannot be patented, and multi-gene hereditary panels have since become the norm, but BRACAnalysis CDx remains the labelled test.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas: how tumours escape and what closes the route · Lines of therapy.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Companion diagnostic for olaparib in germline BRCA-mutated advanced ovarian cancer |
| US | 2018 | Olaparib and talazoparib in germline BRCA-mutated HER2-negative metastatic breast cancer |
| US | 2019 | Olaparib maintenance in germline BRCA-mutated metastatic pancreatic cancer |
| US | 2020 | Olaparib in germline BRCA-mutated metastatic castration-resistant prostate cancer |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Notes
top- What a result means: a pathogenic BRCA1/2 variant makes PARP inhibitors an option, raises the case for risk-reducing surgery or surveillance, and means blood relatives can be tested.
Latest papers
topQuery for this drug: (TITLE:"BRACAnalysis CDx" OR ABSTRACT:"BRACAnalysis CDx") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about BRACAnalysis CDx, not a curated reading list.
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