Lynparza scores two new EU approvals

AstraZeneca and MSD's immunotherapy Lynparza (olaparib) has scored two new approvals in the European Union.

The first approval for Lynparza is for the first-line maintenance treatment, alongside bevacizumab, in patients with HRD-positive advanced ovarian cancer.

The European Commission based its approval on results from the PAOLA-1 phase III trial, in which Lynparza added to bevacizumab improved the median time patients live without disease progression by more than three years compared to bevacizumab alone.

“For women with advanced ovarian cancer, the goal of first-line treatment is to delay disease progression for as long as possible with the intent of achieving long-term remission. Unfortunately, once a patient’s cancer recurs, it historically has been incurable,” said Isabelle Ray-Coquard, principal investigator of the PAOLA-1 phase III trial and medical oncologist, Centre Léon Bérard and president of the GINECO group.

“Lynparza together with bevacizumab has demonstrated an impressive median progression-free survival benefit of more than three years and is poised to become the standard of care for eligible patients with HRD-positive tumours in the EU,” she added.

Following that approval, the EC also gave Lynparza a green light for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA 1/2 mutations.

Results from the PROfound phase III trial supported this approval, in which Lynparza more than tripled median radiographic progression-free survival (rPFS) versus enzalutamide or abiraterone and reduced the risk of disease progression or death by 78%.

The median overall survival was 20.1 months versus 14.4 monhts for mCRPC patients with BRCA 1/2 mutations.

“Lynparza more than tripled radiographic progression-free survival and is the only PARP inhibitor to show an overall survival benefit versus certain new hormonal agents for men with BRCA-mutated metastatic castration-resistant prostate cancer,” said Dave Fredrickson, executive vice president, oncology business unit, AZ.

“This approval means BRCA testing should now become a critical step in the diagnosis and determination of treatment for men with advanced prostate cancer in the EU,” he added.