September 20, 2024 - Vientiane, Laos - BigBear Pharma, a leading biopharmaceutical company focused on developing and commercializing innovative cancer therapies, announces that Olaparib has been approved by the Lao Ministry of Health.
Olaparib
Olaparib is a PARP (poly ADP-ribose polymerase) inhibitor that blocks DNA repair enzymes, making it difficult for DNA in cancer cells to be repaired, thereby leading to cell death and delaying or stopping tumor progression. Its indications include various malignancies such as ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. It is sold under the brand name OLADX in Laos. Lao Registration No.: Lao Reg No.: 08L1169/24 50mg.
Indications and Target Population
Olaparib is indicated for adult cancer patients with specific molecular markers (BRCA mutation, HRD positive, HRR gene mutation, etc.) confirmed by an FDA-approved companion diagnostic, including:
1. Patients with advanced/recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer carrying BRCA mutation or HRD positive;
2. Patients with gBRCA mutation, HER2-negative high-risk early or metastatic breast cancer;
3. Patients with metastatic pancreatic adenocarcinoma carrying gBRCA mutation;
4. Patients with metastatic castration-resistant prostate cancer carrying HRR gene mutation or BRCA mutation.
Dosage and Administration
1. Standard Dose
The recommended dose of Olaparib is 300 mg taken orally twice daily, with or without food. If a patient misses a dose, do not take an extra dose; take the next dose at the scheduled time. Swallow tablets whole; do not chew, crush, dissolve, or split.
2. First-Line Maintenance Treatment of BRCA-Mutated Advanced Ovarian Cancer
Continue treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. If the patient achieves complete response (no radiographic evidence of disease) at 2 years, discontinue treatment; if there is still evidence of disease and the treating physician assesses that continued treatment may provide further benefit, treatment may be continued beyond 2 years.
3. First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab
Olaparib continues until disease progression, unacceptable toxicity, or completion of 2 years; discontinue at 2 years in patients with complete response, or extend treatment if there is evidence of disease and the physician assesses benefit. The recommended dose of bevacizumab is 15 mg/kg every 3 weeks, with a total treatment duration (including the chemotherapy period) of 15 months. Please refer to the bevacizumab prescribing information for details.
4. Adjuvant Treatment of gBRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer
Continue treatment for 1 year, or until disease recurrence or unacceptable toxicity, whichever occurs first. If the patient has HR-positive, HER2-negative breast cancer, endocrine therapy should be continued according to current clinical practice guidelines.
Maintenance treatment of BRCA-mutated recurrent ovarian cancer, treatment of gBRCA-mutated HER2-negative metastatic breast cancer, first-line maintenance treatment of gBRCA-mutated metastatic pancreatic adenocarcinoma, treatment of HRR gene-mutated metastatic castration-resistant prostate cancer: continue until disease progression or unacceptable toxicity.
5. Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone/Prednisolone
Olaparib continues until disease progression or unacceptable toxicity; the recommended dose of abiraterone is 1000 mg orally once daily in combination with prednisone or prednisolone 5 mg orally twice daily. Please refer to the abiraterone prescribing information for details. In addition, patients with mCRPC receiving Olaparib should also receive a gonadotropin-releasing hormone (GnRH) analog or have undergone bilateral orchiectomy.
Adverse Reactions
Monotherapy
Nausea, fatigue (including asthenia), anemia, vomiting, diarrhea, decreased appetite, headache, dysgeusia, cough, neutropenia, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia.
Combination with Bevacizumab
Nausea, fatigue (including asthenia), anemia, lymphopenia, vomiting, diarrhea, neutropenia, leukopenia, urinary tract infection, headache.
Combination with Abiraterone and Prednisone/Prednisolone
Anemia, fatigue, nausea, diarrhea, decreased appetite, lymphopenia, dizziness, abdominal pain.
