NICE approves olaparib for relapsed ovarian, fallopian tube, or peritoneal cancer


  • Dawn O'Shea
  • Oncology drug update
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NICE has approved olaparib for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy if they have a BRCA1 or BRCA2 mutation and have had ≥3 courses of platinum-based chemotherapy.

The treatment is also approved for use within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy if they have a BRCA1 or BRCA2 mutation and have had two courses of platinum-based chemotherapy.

The clinical trial evidence came from the study 19 and SOLO 2 trials.

In study 19 there was a statistically significant improvement in progression-free survival (PFS) in the overall population compared with placebo; 8.4 months with olaparib and 4.8 months with placebo (HR 0.35; 95% CI 0.25-0.49).

For BRCA-negative patient, median PFS difference between olaparib and placebo was 1.9 months (HR 0.54; 95% CI 0.34-0.85). For BRCA-positive patients, the difference was 6.9 months (HR 0.18; 95% CI 0.10-0.31).

In SOLO 2 there was a statistically significant PFS benefit of 13.6 months with olaparib (HR 0.30; 95% CI 0.22-0.41 at a median follow-up of 22 months).

The only mature overall survival data (OS) came from study 19. The data showed that at a median follow-up of 6.5 years, median OS in the total population was 29.8 months with olaparib and 27.8 months with placebo (HR 0.73; 95% CI 0.55-0.95), but this was not significant.

NICE also concluded that the criteria for inclusion in the Cancer Drugs Fund were met for people with a BRCA mutation who have had two courses of platinum-based chemotherapy.