Views: 58 Author: Unibest Publish Time: 2025-03-10 Origin: Site
New Approval of Olaparib Indication
Earlier this year, on January 2nd, AstraZeneca and Merck jointly announced that their PARP inhibitor Lynparza® (Generic name: olaparib) has received approval for a new indication in China. The new approval is for the adjuvant treatment of adult patients with early-stage, high-risk breast cancer who have harmful or suspected harmful germline BRCA mutations (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative status. This indication applies to patients who have previously received neoadjuvant or adjuvant chemotherapy.
This approval expands the use of olaparib in the early breast cancer setting, offering a new treatment option for a specific subset of patients with genetic predisposition to breast cancer. The approval is significant for healthcare professionals in the oncology field, particularly those specializing in breast cancer treatment.
According to the AstraZeneca press release, as of December 25, 2024, Lynparza (olaparib) is the first and only targeted therapy approved in mainland China for early-stage breast cancer with BRCA mutations.
About Olaparib
Olaparib, independently developed by AstraZeneca, is a PARP inhibitor and the first targeted therapy to block the DNA damage repair (DDR) pathway in cells or tumors with homologous recombination repair (HRR) deficiencies, such as BRCA1 and/or BRCA2 mutations. It can also address deficiencies caused by other medications, including new hormonal therapies.
This approval is based on the positive results from the OlympiA Phase III trial. OlympiA is a Phase III, double-blind, parallel, placebo-controlled, multicenter study designed to compare the efficacy and safety of olaparib tablets versus placebo as adjuvant treatment in patients with germline BRCA-mutated, high-risk, HER2-negative early breast cancer. The study included patients who had completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
This clinical trial and subsequent approval represent a significant advancement in the treatment of early-stage breast cancer, particularly for patients with specific genetic mutations. The availability of a targeted therapy in this setting could potentially improve outcomes for a subset of high-risk breast cancer patients in China.
The detailed results of this trial were published in the New England Journal of Medicine in June 2021. The data revealed:
Compared to placebo, olaparib demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS). It reduced the risk of invasive breast cancer recurrence, new cancer occurrence, or death by 42%.
Olaparib also showed a statistically significant and clinically meaningful improvement in overall survival (OS). Compared to placebo, it reduced the risk of death by 32%.
Regarding safety, olaparib's safety and tolerability profile was consistent with observations from previous clinical trials.
Collaboration of AstraZenca and Merck
In July 2017, AstraZeneca and Merck announced a global strategic oncology collaboration to jointly develop and commercialize olaparib, the world's first PARP inhibitor, for multiple cancer indications. The agreement had a potential total value of up to $8.5 billion, including $1.6 billion in upfront payment, $750 million for certain license options, and up to $6.15 billion in additional payments upon successful achievement of future regulatory and sales milestones.
Olaparib has received five approvals in China since its initial approval in August 2018. Here's a summary of these approvals:
August 2018:
Indication: Maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission after platinum-based chemotherapy.
December 2019:
Indication: Maintenance treatment for adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer carrying germline or somatic BRCA mutations (gBRCAm or sBRCAm) who have achieved complete or partial remission after first-line platinum-based chemotherapy.
June 2021:
Indication: Treatment for adult patients with metastatic castration-resistant prostate cancer carrying germline or somatic BRCA mutations (gBRCAm or sBRCAm) who have failed previous treatments (including a novel endocrine drug).
September 2022:
Indication: Maintenance treatment in combination with bevacizumab for adult patients with homologous recombination deficiency (HRD) positive advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission after first-line platinum-based chemotherapy combined with bevacizumab.
January 2025:
Indication: Adjuvant treatment for adult patients with high-risk early-stage breast cancer that is HER2-negative and carries harmful or suspected harmful germline BRCA mutations (gBRCAm), who have received neoadjuvant or adjuvant chemotherapy.
These approvals demonstrate the expanding use of olaparib in various cancer types and treatment settings in China, particularly in ovarian, prostate, and breast cancers with specific genetic profiles.
Unibest's Offer to Olaparib Development
As a leading pharmaceutical supplier, Unibest helps the global development and production of Olaparib by providing high-quality API to pharmaceutical companies worldwide.
