US regulator grants fast review for AZ ovarian cancer drug

The US Food and Drug Administration (FDA) has granted AstraZeneca priority review for its ovarian cancer drug Lynparza – and the company has also revealed positive results for its diabetes medicine Farxiga.

Lynparza (olaparib) is a maintenance monotherapy treatment for patients with newly diagnosed,BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following 1st-line standard platinum-based chemotherapy.

If it is approved, the new use for Lynparza tablets will be the drug’s fourth indication in the US. The poly ADP-ribose polymerase (PARP) inhibitor will be used as a first-line maintenance medicine – the first US regulatory submission of its kind.

In July last year, AstraZeneca announced that it was working in partnership with Merck & Co – known as MSD outside the US and Canada – to develop and commercialise Lynparza to treat various types of cancer.

AstraZeneca describes Lynparza as the “first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells”.

Research indicates that Lynparza may work by inhibiting PARP-enzymatic activity and by increasing the formation of PARP-DNA complexes, which kills cancer cells.

The phase III SOLO-1 trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Lynparza compared to placebo.

The drug reduced the risk of disease progression or death by 70% in patients with newly diagnosed, BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy.

Nearly two-thirds (60%) of women on the therapy remained progression-free at 36 months, in contrast to just 27% of those who were given a placebo.

Also, AstraZeneca announced that its final-phase study of Farxiga (dapagliflozin) showed that the therapy significantly reduced hospitalisation for heart failure and cardiovascular death in patients with type-2 diabetes by 17% when compared to a placebo.

Elisabeth Björk, vice president, AstraZeneca’s head of cardiovascular, renal and metabolism, global medicines development, said: “These positive results are clinically relevant to the 425 million people worldwide living with diabetes, of whom those with type-2 diabetes have a two-to-five times greater risk of heart failure along with an increased risk of a heart attack or stroke.

“Heart failure survival rates are only 50% after five years from diagnosis, which is why these new findings are so important in broadening our understanding of how to go beyond blood glucose so we may better address this serious and often overlooked cardiovascular complication.”