AstraZeneca and MSD have received a positive opinion for Lynparza (olaparib) as a first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.
The decision was made by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
This first-in-class poly adenosine diphosphate ribose polymerase (PARP) inhibitor can now be used as a maintenance treatment for adult patients with advanced BRCA1/2-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.
CHMP’s decision is based on data from pivotal Phase III trial SOLO-1 trial, which showed that the inhibitor reduced disease progression risk or death by 70% compared to placebo.
The randomised, double-blinded, placebo-controlled, multicentre trial evaluated the efficacy and safety of the tablets as a maintenance monotherapy.
MSD Research Laboratories senior vice-president, Global Clinical Development head and chief medical officer Roy Baynes said: “Women with advanced ovarian cancer need and deserve new treatment options.
“In the SOLO-1 trial, Lynparza demonstrated a significant progression-free survival benefit as maintenance treatment for patients with advanced BRCA-mutated ovarian cancer following response to first-line platinum-based chemotherapy.”
Lynparza is currently approved in 64 countries as a treatment for platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is also available in 38 countries for germline BRCAm HER2-negative metastatic breast cancer.
Regulatory reviews are currently underway in other jurisdictions for ovarian and breast cancer.
Lynparza is being jointly developed and commercialised by AstraZeneca and MSD. It is being tested in a range of tumour types with defects and dependencies in the DNA damage response (DDR).
Earlier this month, the European Commission approved Lynparza as a monotherapy to treat locally advanced or metastatic breast cancer in adults.