EMA Recommends Extension of Therapeutic Indications for Olaparib to Patients with Endometrial Cancer

On June 27, 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended a change to the marketing authorization terms for the drug Olaparib.

AstraZeneca AB is the marketing authorization holder for Olaparib.

The CHMP approved a new indication for Olaparib in combination with durvalumab for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) and has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.

All indications for Olaparib will include:

1. Ovarian cancer

Olaparib is indicated for maintenance treatment of adult patients with BRCA1/2-mutated high-grade ovarian, Fallopian tube, or peritoneal cancer in response following completion of platinum-based chemotherapy. Olaparib in combination with bevacizumab is indicated for maintenance treatment of patients with high-grade ovarian cancer in response following first-line platinum-based chemotherapy with bevacizumab and HRD positive status.

2. Breast cancer

Olaparib is indicated for adjuvant treatment of adult patients with germline BRCA1/2 mutations and high-risk early breast cancer previously treated with chemotherapy. It is also indicated for patients with locally advanced or metastatic breast cancer who have undergone prior treatment with anthracycline, taxane, and endocrine therapy.

3. Adenocarcinoma of the pancreas

Olaparib is approved for use as a single treatment for maintaining the health of adult patients with metastatic adenocarcinoma of the pancreas who carry germline BRCA1/2 mutations, and who have not experienced progression after at least 16 weeks of platinum treatment in their initial chemotherapy regimen.

4. Prostate cancer

Olaparib is approved for use in the following ways:

As a single treatment for adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (either inherited or acquired) who have advanced after previous therapy that included a new hormonal agent.

In conjunction with abiraterone and prednisone or prednisolone for adult patients with mCRPC for whom chemotherapy is not recommended.

5. Endometrial cancer

Olaparib, in combination with durvalumab, is recommended for maintaining the health of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR), and whose disease has not progressed while receiving initial treatment with durvalumab along with carboplatin and paclitaxel.