Olaparib / Lynparza (Everest)

Product Overview

Olaparib (also known as Olaparib; Brand name: Lynparza) manufactured by Everest Pharma is a PARP (Poly ADP-ribose Polymerase) inhibitor that works by blocking DNA repair enzymes, making it difficult for cancer cells to repair damaged DNA. This ultimately leads to cancer cell death and helps slow or stop tumor progression.

Olaparib has been approved by the U.S. FDA for the treatment of ovarian cancer, breast cancer, prostate cancer, and pancreatic cancer. Its therapeutic potential in additional tumor types continues to expand, making it a promising broad-spectrum targeted anticancer therapy.

PARP inhibitors function by suppressing DNA damage repair pathways in tumor cells, thereby promoting apoptosis and enhancing the effects of radiotherapy, alkylating agents, and platinum-based chemotherapy.

📊 Clinical Development & Approval History

Olaparib (Lynparza) became the world’s first PARP inhibitor approved by the FDA for recurrent ovarian cancer in December 2014.

Clinical studies demonstrated:

• Median progression-free survival (PFS) extended to 19.1 months
• 65% reduction in the risk of disease progression or death

The treatment showed benefit regardless of BRCA1/2 mutation status.

Key Regulatory Milestones

• 2017: FDA expanded approval for maintenance treatment in platinum-sensitive recurrent epithelial ovarian cancer
• 2018: Approved for BRCA-mutated HER2-negative metastatic breast cancer
• 2018: Approved in China as the country’s first PARP inhibitor
• Later approvals included metastatic pancreatic cancer and prostate cancer indications
• 2022–2023: Included in China’s national reimbursement system, improving patient accessibility

Olaparib has significantly advanced treatment strategies for ovarian, breast, prostate, and pancreatic cancers worldwide.

📌 Indications

1. Ovarian Cancer

For maintenance treatment of platinum-sensitive recurrent ovarian cancer, regardless of BRCA mutation status.

2. Breast Cancer

For treatment of patients with BRCA-mutated HER2-negative metastatic breast cancer.

💊 Dosage and Administration

Treatment Guidance

• Continue treatment until disease progression or unacceptable toxicity occurs
• Dose interruption or reduction may be considered for adverse reactions

⚠️ Special Considerations

Breastfeeding

Patients should discontinue breastfeeding during treatment with Olaparib.

⚠️ Common Side Effects

Common adverse reactions may include:

• Anemia
• Nausea
• Fatigue
• Vomiting
• Diarrhea
• Taste disturbances
• Indigestion
• Decreased appetite
• Headache
• Muscle pain
• Rash