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SMC ID Date Medicine Submission Type Indication
SMC2797 13/10/2025 durvalumab (Imfinzi) Full

In combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with:

  • durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
  • durvalumab in combination with olaparib in endometrial cancer that ismismatch repair proficient (pMMR).
SMC2737 10/02/2025 olaparib (Lynparza) Abbreviated

Monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2−negative locally advanced or metastatic breast cancer (mBC). Patients should 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. Patients with HR+ breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

SMC2617 11/03/2024 olaparib (Lynparza) Full

In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

SMC2518 09/10/2023 olaparib (Lynparza) Full

As monotherapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy.

SMC2368 13/12/2021 olaparib (Lynparza) Full

In combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

SMC2435 08/11/2021 olaparib (Lynparza) Non submission

As monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

SMC2436 08/11/2021 olaparib (Lynparza) Non submission

As monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should 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.

SMC2366 11/10/2021 olaparib (Lynparza) Full

As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

SMC2367 09/08/2021 olaparib (Lynparza) Abbreviated

As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

SMC2209 09/12/2019 olaparib (Lynparza) Full

As monotherapy for the maintenance treatment of adult patients with newly diagnosed advanced (FIGO stages III and IV) BRCA1/2‐mutated (germline and/or somatic) high‐grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first line platinum‐based chemotherapy.

1047/15 07/11/2016 olaparib (Lynparza) Resubmission Monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

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