AstraZeneca’s (LON:AZN) Lynparza (olaparib) is not exhibiting an alarming level of secondary malignancies, said experts based on an FDA adverse events (AEs) document this news service obtained through a Freedom of Information Act (FOIA) request.
The risk for secondary malignancies developing due to Lynparza treatment was a concern for the Advisory Committee that reviewed the drug’s maintenance treatment approval application.
Experts agreed that secondary malignancies remains a question for such earlier, preventive use, but the incidences mentioned in the AE reports based on Lynparza as a latter-line treatment are not unexpected and in line with previous data.
The document, which includes AEs submitted to the FDA’s Adverse Event Reporting System (FAERS) between 22 December 2014 and 1 September 2016, also noted reports filed based on off-label use including that in male patients. Lynparza is only approved for ovarian cancer.
The off-label usage, experts said, was likely in patients with somatic BRCA mutations or those who received it earlier than the mandated fourth-line usage, neither of which have faced major insurance coverage concerns.