The US Food and Drug Administration (FDA) has granted priority review for Lynparza (olaparib) in combination with bevacizumab to treat advanced ovarian cancer.
The federal agency accepted a supplemental New Drug Application for the combination for patients with advanced ovarian cancer showing complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab.
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FDA granted the priority review based on the Phase III PAOLA-1 trial. The trial compared the efficacy of Lynparza when added to standard-of-care (SoC) bevacizumab against bevacizumab as single-drug therapy.
Results showed that the combination reduced the risk of advanced ovarian cancer progression or death by 41% compared to patients treated with bevacizumab alone. It also improved progression-free survival (PFS) of the patients.
Furthermore, around 46% of the patients administered with Lynparza added to bevacizumab exhibited no disease progression after two years of trial initiation. The figure stood at 28% for patients treated with bevacizumab alone.
Lynparza is a PARP inhibitor developed to block DNA damage response (DDR) in cells / tumours unable to carry out homologous recombination repairs such as mutations in BRCA1 or BRCA2.
Currently, the drug has approval in 65 countries for the treatment of platinum-sensitive relapsed ovarian cancer.
It also has approval in multiple countries, including the US, as the first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following platinum-based chemotherapy.
Lynparza is also known to treat germline BRCA-mutated, HER2-negative, metastatic breast cancer in the EU and germline BRCA-mutated metastatic pancreatic cancer in the US.
Several other regulatory reviews are also underway.
