The approval by the European Commission, the third indication for Lynparza in the EU, will make the drug available for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response following completion of first-line platinum-based chemotherapy.
While 70% of women with ovarian cancer relapse within three years of initial chemo treatment, Lynparza, which is a result of a collaboration between AstraZeneca and MSD (Merck), has been proved to significantly increase progression-free survival.
In the Phase III SOLO-1 trial testing Lynparza as maintenance monotherapy following chemotherapy, it demonstrated a 70% reduction in the risk of disease progression or death.
Following this new approval for Lynparza, the oncology collaboration with Merck dictates that AstraZeneca will receive $30mln as ongoing collaboration revenue, which the company anticipates will be booked during the second quarter of 2019.
Prior to its collaboration with Merck for Lynparza, AstraZeneca had been targeting annual peak sales of $2bn for the drug, of which $400mln was from ovarian cancer.
Broker Shore Capital noted that, to date, AstraZeneca has recognised circa $2.6bn from the Lynparza collaboration out of a total deal value of circa $8.5bn, of which $140mln relates to regulatory milestones.
"We also think that for FY2019F consensus is forecasting c$600m of Collaboration Revenue from the Merck collaboration, of which $100m is a final option payment (for combo trials between Merck’s Keytruda and Lynparza) and a further $500mln relating to regulatory and sales-milestones."
Astra shares were up 1% to 6,321.86p on Tuesday morning.