The U.S. Food and Drug Administration said on Friday it has approved expanded use of AstraZeneca Plc’s cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene.
The drug belongs to a class of drug known as PARP inhibitors that has already been used to treat advanced BRCA-mutated ovarian cancer, the FDA said.
This is the first time a PARP inhibitor has been approved to treat breast cancer and the first time any drug has been approved to treat certain patients with metastatic breast cancer associated with the same genetic mutation.
“This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of cancer, often across cancer types,” said Dr. Richard Pazdur, head of the FDA’s oncology products division. Between 5-10 percent of patients with breast cancer have a BRCA mutation.
Patients are selected for treatment based on a diagnostic test made by Myriad Genetics Inc known as BRACAnalysis CDx. In 2014 Myriad won FDA approval for the test to help identify patients with the advanced ovarian cancer considered eligible for treatment with the drug after others have failed.
In July AstraZeneca and Merck & Co announced a global strategic oncology collaboration to jointly co-develop and co-commercialize Lynparza, an oral treatment known also as olaparib, for multiple cancer types, both as a monotherapy and in combination with other potential drugs.
(Reporting by Toni Clarke in Washington; Editing by Nick Zieminski and Susan Thomas)