The FDA has approved GlaxoSmithKline’s Zejula (niraparib) for a wider ovarian cancer indication, making it the first PARP class drug approved for a broader group of patients without the BRCA mutation. This approval covers advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have undergone three or more prior chemotherapy regimens.
Key Points:
- New Indication: Includes cancers with genomic instability and those progressing more than six months after the last platinum-based chemotherapy.
- Clinical Trial Basis: The expanded indication is based on the QUADRA study, a phase 2, multi-centre, open label, single arm clinical study.
- Patient Population: Enrolled a broad patient population, including women with BRCA+ platinum-sensitive, resistant, and refractory disease, as well as women with HRD+ platinum-sensitive disease.
- Efficacy: Demonstrated clinically meaningful and durable benefit with an objective response rate of 24% and a median duration of response of 8.3 months.
- Sub-analyses: Showed an overall response rate of 20% in patients without BRCA mutations but with genomically unstable platinum-sensitive cancers, and the highest ORR of 39% in platinum-sensitive BRCA positive cancers.
This approval represents a significant step forward in the treatment of ovarian cancer, expanding the population eligible for PARP inhibitor treatment and highlighting the importance of genomic instability in determining treatment eligibility.
