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Olanib

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Olanib (Olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Olanib (Olaparib)

 

 Indications

Olanib (Olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

The indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

Therapeutic Class

Targeted Cancer Therapy

Product Description

 

Olanib 50mg Capsules is used to treat advanced ovarian cancer (with deleterious germline BRCA mutated (gBRCAm) as detected by an FDA-approved test) who have been treated with three or more prior lines of chemotherapy. Also been used to treat HER2-negative metastatic breast cancer (with deleterious or suspected gBRCAm), who have been treated with chemotherapy. Generic Olaparib is a targeted therapy. Olaparib is a poly (ADP-ribose) polymerase (PARP) enzyme inhibitor, including PARP1, PARP2, and PARP3. PARP enzymes are involved in DNA transcription, cell cycle regulation, and DNA repair. Olaparib is a potent oral PARP inhibitor which induces synthetic lethality in BRCA 1/2 deficient tumor cells through the formation of double-stranded DNA breaks which cannot be accurately repaired, which leads to disruption of cellular homeostasis and cell death.

Storage Conditions

Store at 25ºC

Product Specification:

Packaging Type bottle
Usage/Application For advanced Ovarian cancer,8 capsules twice daily (400 mg per dose) with or without food. Olanib
Product Type targeted therapy
Composition Olaparib
Drug Name Olanib
Dose/Strength 50mg
Dosage Form 50mg capsules
Form of Medicine capsules

Manufacturing By: Everest Pharmaceuticals Ltd

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