Opening a new chapter in the use of genomic science to fight cancer, the Food and Drug Administration (FDA) has approved olaparib, a medication for advanced ovarian cancer associated with a defective BRCA gene.
The new drug, to be marketed under the commercial name Lynparza, was found in a preliminary clinical trial to shrink or eliminate ovarian tumors in women whose cancers bore a specific genetic fingerprint and who had undergone at least three prior lines of chemotherapy.
Based on Lynparza’s “existing objective response rate and duration of response data,” the drug safety agency granted the medication’s maker, Astra-Zeneca, an “accelerated” approval. Roughly a third of women with the genetic mutation targeted by Lynparza saw partial shrinkage or complete disappearance of their ovarian tumors over an average of eight months.
At the same time, the FDA granted marketing approval for a “companion diagnostic” that will help identify women whose advanced ovarian cancer is likely to respond to the drug. That test, BRACAnalysis CDx, is made by Myriad Genetics Inc. To be a candidate for Lynparza, a patient must take the test and show positive for a specific mutation of the BRCA gene, which confers a high risk of both breast and ovarian cancer.