2 Information about olaparib

2 Information about olaparib

Marketing authorisation indication

Olaparib (Lynparza, AstraZeneca) as tablets is indicated as 'monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages 3 and 4) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy'.

Dosage in the marketing authorisation

Olaparib is taken orally. It is currently available both in a tablet and a capsule formulation. However, the capsule formulation is only licensed for people with relapsed BRCA mutation-positive platinum-sensitive ovarian cancer and will be phased out when no longer needed by patients. The marketing authorisation relevant to the current appraisal is for olaparib tablets. Therefore, only olaparib tablets are covered by this appraisal.

The dosage of olaparib as tablets is 300 mg (2 × 150 mg tablets) taken twice daily (600 mg per day). A 100-mg tablet is available for dose reductions.

For first-line maintenance treatment, it is recommended that olaparib is continued until radiological disease progression, unacceptable toxicity, or for up to 2 years if there is no radiological evidence of disease. Patients with evidence of disease at 2 years, who in the opinion of the treating physician can derive further benefit from continuous treatment, can have treatment beyond 2 years.

Price

The list price for tablets is £2,317.50 per 14-day pack; £4,635.00 per 28-day cycle (excluding VAT; BNF online, accessed May 2019). The company has a commercial arrangement.

  • National Institute for Health and Care Excellence (NICE)