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FDA Awards Priority Review Status to Ovarian Cancer Drug

The U.S. regulatory agency announced it will accelerate the review period for Lynparza (Olaparib), a maintenance monotherapy treatment for patients with newly diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer. AstraZeneca, the company behind this drug, also revealed positive results for its diabetes medicine Farxiga. A Priority Review is granted to medical products that can bring “significant [...]

The U.S. regulatory agency announced it will accelerate the review period for Lynparza (Olaparib), a maintenance monotherapy treatment for patients with newly diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer. AstraZeneca, the company behind this drug, also revealed positive results for its diabetes medicine Farxiga.

A Priority Review is granted to medical products that can bring “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications”. It means a commitment to examine and take action upon an application earlier compared to standard review.

In a recent phase III SOLO-1 trial, Lynparza managed to reduce the risk of disease progression or death by 70% and nearly 60% of all participants remained progression-free at 36 months (in contrast to only 27% displayed by the placebo group).

The press release describes Olaparib as “first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells”.

PARP, or Poly (ADP-ribose) polymerase, proteins play a crucial role in the tumor DNA repair process. BRCA-mutated tumor cells rely on PARP activation, and this is why a number of new treatment specifically focus this interaction.

Additionally, AstraZeneca reported that Farxiga (Dapagliflozin) considerably reduced hospitalization for heart failure and cardiovascular death in patients with type-2 diabetes by 17% when compared to a placebo.

Elisabeth Björk, Vice President to the company and Head of Cardiovascular department noted that “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.”

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