Thursday, 28 March, 2024
HomeWeekly RoundupFDA approves expanded use of PARP inhibitor drug

FDA approves expanded use of PARP inhibitor drug

The US Food and Drug Administration has announced that it has approved expanded use of AstraZeneca's cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene, reports Reuters Health. 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 a cancer, often across cancer types,” Dr Richard Pazdur, head of the FDA’s oncology products division is quoted in the report as saying. Between 5%-10% 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 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-commercialise Lynparza, an oral treatment known also as olaparib, for multiple cancer type, both as a monotherapy and in combination with other potential drugs.

[link url="https://www.reuters.com/article/us-astrazeneca-cancer-fda/fda-approves-expanded-use-of-astrazeneca-cancer-drug-idUSKBN1F11TO"]Reuters Health report[/link]

MedicalBrief — our free weekly e-newsletter

We'd appreciate as much information as possible, however only an email address is required.