US regulators have accepted an application from AstraZeneca and MSD for use of Lynparza as maintenance treatment for patients with newly-diagnosed, BRCA-mutated advanced ovarian cancer.
The submission, which has been assigned a priority review, is seeking approval for the PARP inhibitor for use in patients who were in complete or partial response following first-line standard platinum-based chemotherapy.
According to the firms, this is the first US regulatory submission acceptance for a PARP inhibitor in the first-line maintenance setting for advanced ovarian cancer, and if approved will be the fourth indication for Lynparza in the US.
This file contains data from the pivotal Phase III SOLO-1 trial, which showed “a statistically-significant and clinically-meaningful” improvement in progression-free survival (PFS) for Lynparza (olaparib) compared to placebo, reducing the risk of disease progression or death by 70%.
Of those receiving Lynparza, 60% remained progression-free at 36 months compared to 27% of women in the placebo arm, according to the data, which were presented at the ESMO 2018 Congress (European Society for Medical Oncology) and published online in the New England Journal of Medicine.
Lynparza is currently approved in over 60 countries for the treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is also approved in several countries, including the US and Japan, for germline BRCAm HER2-negative metastatic breast cancer - regulatory reviews are underway in the EU, Japan and other markets.
Meanwhile, AZ also announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial for its diabetes drug Farxiga (dapagliflozin).
Results showed that Farxiga significantly reduced the risk of hospitalisation for heart failure or CV death composite versus placebo by 17% (4.9% vs. 5.8%), one of the two primary efficacy endpoints. The reduction was consistent across the entire patient population, which included those with CV risk factors and those with established CV disease.
Additionally, there were fewer major adverse cardiovascular events (MACE) observed with Farxiga for the other primary efficacy endpoint, however this did not reach statistical significance (8.8% for Farxiga versus 9.4% for placebo), the firm noted.
“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,” said Elisabeth Björk, vice president, head of Cardiovascular, Renal and Metabolism, Global Medicines Development at AZ.
“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.”