Opening a new chapter in the use of genomic science to fight cancer, the Food and Drug Administration on Friday 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.
“Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the news release.
Pazdur called Lynparza “an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.”
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.