The Food and Drug Administration approved olaparib, a medication for advanced ovarian cancer, associated with a defective BRCA gene.
This new approval is the beginning of a chapter in the use of genomic science to fight cancer.
The new drug will be marketed under the commercial name Lynparza.
It 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.
About 1/3 of women with the genetic mutation targeted by Lynparza saw partial shrinkage or complete disappearance of their ovarian tumors over an average of 8 months.
Based on the drug’s existing objective response rate and duration of response data, the drug safety agency granted its maker, Astra-Zeneca, an “accelerated” approval.
The FDA has simultaneously granted marketing approval for a “companion diagnostic” that will help identify women whose advanced ovarian cancer is likely to respond to the drug. In order to be a candidate for Lynparza, a patient must take the test, BRACAnalysis, and show positive for a specific mutation of the BRCA gene, which confers a high risk of both breast and ovarian cancer.
These two approvals constitute the first of a new class of drugs for treating ovarian cancer.
Lynparza is the first of a new class of drugs called poly ADP-ribose polymerase (PARP) inhibitors, which work by blocking the action of an enzyme that helps repair DNA. In certain tumor cells, such as those seen in BRCA1 and BRCA2 mutation carriers, blocking this enzyme can lead to cell death.
This class of drugs is opening a while new avenue of therapy. These drugs work in a fundamentally different way than chemotherapy. This is a cancer treatment that’s been designed to hit this kind of inherited genetic weakness in the cancer itself.