medwireNews: The US FDA has expanded the indication of olaparib to include metastatic breast cancer patients with a deleterious or suspected deleterious germline BRCA mutation.
The PARP inhibitor – which is already used for BRCA-mutated advanced ovarian cancer – may now be given to women who have previously received neoadjuvant or adjuvant chemotherapy for HER2-negative primary or metastatic breast cancer. Patients with hormone receptor-positive tumours should also have received endocrine therapy or be considered unsuitable for such treatment.
The announcement follows results from the OlympiAD trial, which demonstrated significantly delayed disease progression in this population with olaparib versus chemotherapy.
Patients must be selected for olaparib treatment using an FDA-approved companion diagnostic test and the PARP inhibitor should be taken orally as a twice daily dose of 150 mg with or without food.
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