Olakin 150

Olakin 150 Tablet: Each film coated tablet contains Olaparib INN 150 mg.
Pharmacology:
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes,
including PARP1, PARP2, and PARP3. PARP enzymes are involved in
normal cellular homeostasis, such as DNA transcription, cell cycle
regulation, and DNA repair. Olaparib has been shown to inhibit growth of
select tumor cell lines in vitro and decrease tumor growth in mouse
xenograft models of human cancer both as monotherapy or following
platinum-based chemotherapy. Increased cytotoxicity and anti-tumor
activity following treatment with Olaparib were noted in cell lines and mouse
tumor models with deficiencies in BRCA. In vitro studies have shown that
Olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic
activity and increased formation of PARP-DNA complex, resulting in
disruption of cellular homeostasis and cell death.
Indications:
Ovarian cancer:
• Olaparib is indicated for the maintenance treatment of adult patients with
deleterious or suspected deleterious germline or somatic
BRCA-mutated advanced epithelial ovarian, fallopian tube or primary
peritoneal cancer who are in complete or partial response to first-line
platinum-based chemotherapy.
• In combination with Bevacizumab for the maintenance treatment of adult
patients with advanced epithelial ovarian, fallopian tube or primary
peritoneal cancer who are in complete or partial response to first-line
platinum-based chemotherapy and whose cancer is associated with
homologous recombination deficiency (HRD)-positive status defined by
either a deleterious or suspected deleterious BRCA mutation, and/or
genomic instability.
• Olaparib is indicated for the maintenance treatment of adult patients with
recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer,
who are in complete or partial response to platinum-based chemotherapy.
• Olaparib is indicated for the treatment of adult patients with deleterious or
suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian
cancer who have been treated with three or more prior lines of chemotherapy.
Breast cancer:
• Olaparib is indicated for the treatment of adult patients with deleterious
or suspected deleterious gBRCAm, HER2-negative metastatic breast
cancer who have been treated with chemotherapy in the neoadjuvant,
adjuvant or metastatic setting. Patients with hormone receptor
(HR)-positive breast cancer should have been treated with a prior
endocrine therapy or be considered inappropriate for endocrine therapy.
Pancreatic cancer:
• Olaparib is indicated for the maintenance treatment of adult patients with
deleterious or suspected deleterious gBRCAm metastatic pancreatic
adenocarcinoma whose disease has not progressed on at least 16
weeks of a first-line platinum-based chemotherapy regimen.
Prostate cancer:
• Olaparib is indicated for the treatment of adult patients with deleterious
or suspected deleterious germline or somatic homologous
recombination repair (HRR) gene-mutated metastatic
castration-resistant prostate cancer (mCRPC) who have progressed
following prior treatment with enzalutamide or abiraterone.