Priority Review Granted by FDA to Olaparib Maintenance Therapy for Some Patients With Ovarian Cancer
Posted: Friday, November 16, 2018
The U.S. Food and Drug Administration (FDA) granted Priority Review to olaparib (Lynparza) tablets as maintenance treatment in patients with newly diagnosed, BRCA-mutated advanced ovarian cancer who were in complete or partial response after first-line standard platinum-based chemotherapy.
This submission was based on results from the phase III SOLO-1 trial (ClinicalTrials.gov identifier NCT01844986). The trial showed a statistically significant and clinically meaningful improvement in progression-free survival with olaparib compared with placebo, reducing the risk of disease progression or death by 70%. With a median 41 months of follow-up, the median progression-free survival for patients treated with olaparib (n = 260) was not reached compared with 13.8 months for patients treated with placebo alone (n = 131). Of patients receiving olaparib, 60% remained free of disease progression at 36 months, compared with 27% of patients in the placebo arm. These data were presented at the European Society for Medical Oncology (ESMO) 2018 Congress, published online in The New England Journal of Medicine, and covered by JNCCN 360.
The most common adverse reactions with olaparib maintenance in t least 20% of patients were nausea (76%), fatigue (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).
