Merck and AstraZeneca get Lynparza OK in China for new indication; BARDA exercises first option with Marinus

AstraZeneca and Merck’s Lynparza is approved in China for yet another indication.

Chinese regulators approved the blockbuster cancer drug and PARP inhibitor as a first-line maintenance treatment for adults in several specific circumstances: with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to first-line platinum-based chemotherapy in combination with Avastin, and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

The approval was based off the Phase III PAOLA-1 trial, where patients on Lynparza plus Avastin following response to a platinum-based chemotherapy saw a PFS improvement in patients with HRD-positive advanced ovarian cancer.

Some of those data were presented at ESMO, but overall survival results were not statistically significant.

Lynparza first got approved in China in 2019 as a first-line…
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