AstraZeneca gets USFDA nod for LYNPARZA as maintenance treatment

The approval was based on positive results from a late-stage study in which the drug, Lynparza, reduced the risk of disease progression or death by 70 per cent in patients who have responded to chemotherapy compared to placebo.

New Delhi: The U.S. Food and Drug Administration approved AstraZeneca Plc's cancer drug developed along with Merck & Co as a first-line maintenance treatment for adults with a form of ovarian cancer, the companies said on Wednesday.

The approval was based on positive results from a late-stage study in which the drug, Lynparza, reduced the risk of disease progression or death by 70 per cent in patients who have responded to chemotherapy compared to placebo.

The FDA decision is shot in the arm for AstraZeneca, which has lost several patents on its older drugs since 2012, wiping out more than half of its sales.

Maintenance therapy means prolonged use and likely higher sales for British drugmaker AstraZeneca, which generated $297 million in Lynparza sales last year.

The drug, approved in 2014 for later use in patients with BRCA mutations and for a certain type of breast cancer, was the first so-called PARP inhibitor to reach the U.S. market.

Lynparza and other drugs belonging to the class of pharmacological inhibitors that are designed to block the DNA repair mechanism of cancer cells so that BRCA-mutated cells fail to replicate and the tumour can no longer sustain itself.