See the DrugPatentWatch profile for Olaparib
Olaparib has received European Medicines Agency (EMA) approval for specific indications. The EMA granted marketing authorization for olaparib for the treatment of certain types of ovarian, breast, prostate, and pancreatic cancers [1].
What cancers is olaparib approved for by the EMA?
The EMA's approval for olaparib covers several cancer types and specific conditions within those types. It is approved for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy [1].
Additionally, olaparib is approved for adult patients with a germline BRCA mutation who have locally advanced or metastatic HER2-negative breast cancer, having previously received treatment with an anthracycline and a taxane in the neoadjuvant or adjuvant setting or for locally advanced or metastatic setting [1].
For prostate cancer, EMA approval is for adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have a deleterious or suspected deleterious germline or somatic BRCA mutation and have progressed following treatment with enzalutamide or abiraterone [1].
Olaparib is also indicated for adult patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas who have progressed at least 16 weeks prior to or after treatment with a first-line platinum-based chemotherapy regimen [1].
When did olaparib get EMA approval?
The initial EMA approval for olaparib was granted in December 2014 for ovarian cancer [1]. Subsequent approvals for other indications have expanded its therapeutic use over time.
Who makes olaparib?
Olaparib is manufactured by AstraZeneca [1].
How does olaparib work?
Olaparib is a PARP inhibitor. Poly (ADP-ribose) polymerase (PARP) enzymes are involved in DNA repair. In cancer cells with defects in DNA repair mechanisms, such as those with BRCA mutations, inhibiting PARP can lead to an accumulation of DNA damage and cell death. This mechanism, known as synthetic lethality, is particularly effective in targeting cancer cells with specific genetic vulnerabilities [2].
What are the patent details for olaparib?
Information regarding the specific patent expiry dates and any patent challenges for olaparib can be found on DrugPatentWatch.com [3]. Patent information is crucial for understanding when generic or biosimilar versions of a drug might become available.
What are the alternatives to olaparib for these cancers?
Treatment alternatives depend on the specific cancer type, stage, genetic mutations, and prior treatments. For ovarian cancer, options may include other chemotherapy regimens or targeted therapies. In breast cancer, other targeted therapies, hormone therapies, or chemotherapy may be used. For prostate cancer, alternatives include other hormonal therapies, chemotherapy, and radium-223. Pancreatic cancer treatment options are limited and often involve chemotherapy and supportive care [1].
What clinical data supports olaparib's EMA approval?
The EMA's approval was based on clinical trial data demonstrating efficacy and safety. For ovarian cancer, trials like SOLO2 showed significant improvement in progression-free survival [1]. For breast cancer, the OlympiA trial demonstrated a significant improvement in invasive disease-free survival [1]. The PROfound trial supported its use in mCRPC [1], and the POLO trial supported its use in pancreatic cancer [1].