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Current Approvals as of May 2019

Two PARP inhibitors are currently approved for breast cancer as of May 2019. The latest information on FDA drug approvals can be found here.

Olaparib

Jan 2018 (Food and Drug Administration, FDA): As monotherapy for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting (patient selection using an FDA-approved companion diagnostic for olaparib) [1, 2]. Patients with hormone receptor-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment.

April 2019 (European Medicines Agency, EMA): As monotherapy for use in patients with germline BRCA1/2-mutations who have HER2-negative locally advanced or metastatic breast cancer and have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting (unless patients were not suitable for these treatments) [3]. Patients with hormone receptor-positive breast cancer should also have progressed on or after prior endocrine therapy or be considered unsuitable for endocrine therapy.

Talazoparib

Oct 2018 (FDA): As monotherapy treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer (patient selection using an FDA-approved companion diagnostic for talazoparib) [4, 5].

In April 2019, talazoparib received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). EMA approval is pending.

References

  1. Food and Drug Administration. FDA approves olaparib for germline BRCA-mutated metastatic breast cancer. 2018.
  2. AstraZeneca. LYNPARZA® (olaparib) tablets for oral use. 2018.
  3. European Medicines Agency. Olaparib Summary of Product Characteristics. 2019.
  4. Food and Drug Administration. FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer. 2018
  5. Pfizer. TALZENNA™ (talazoparib) capsules, for oral use [prescribing information]. New York, NY: Pfizer Inc,2018.

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