Less than a week after the FDA reserved judgment on Merck and AstraZeneca’s Lynparza as a treatment for metastatic castration-resistant prostate cancer (mCRPC), Europe has signed off on its use in the same indication.
On Wednesday, the European Commission gave a thumbs up to the blockbuster PARP inhibitor, used in combination with Johnson & Johnson’s androgen inhibitor Zytiga plus the steroid prednisone or prednisone alone, for adult mCRPC patients who are not recommended for chemotherapy.
Europe’s green light is based on data from the phase 3 PROpel trial which showed that the combination reduced the risk of disease progression by 34% versus standard of care (Zytiga plus prednisone). The inclusion of Lynparza also added more than eight months before disease progression or death.
As for a secondary endpoint of overall survival, the Lynparza arm didn't provide a statistically significant benefit.
With 473,000 cases each year, prostate cancer is the most commonly diagnosed form of cancer among men in Europe. Of these cases, 10% to 20% of patients will develop CRPC within five years, where the survival rate is 30%.
“Many patients with mCRPC are only able to receive one line of active therapy as the disease can progress quickly,” Dave Fredrickson, AZ’s oncology chief, said in a release. “The combination of Lynparza with abiraterone as a first-line treatment expands the use of Lynparza to a broader group of mCRPC patients.”
On Thursday of last week, the companies reported that the FDA had delayed its target date for its decision on Lynparza by three months, to March, to “provide further time for the full review of the submission."
Lynparza’s first endorsement in prostate cancer came in May of 2020, when the FDA sanctioned it for previously treated patients with mutations in their homologous recombination repair (HRR) genes. The drug won its first FDA approval in 2014 for ovarian cancer, followed by its nods in breast cancer (2018) and pancreatic cancer (2019).
Lynparza generated (PDF) sales of $2.75 billion for AZ in 2021, a 21% increase from the previous year. Merck reported $989 million in sales from the drug last year, a 36% increase from 2020.
In prostate cancer, Lynparza already owns an edge over chief PARP inhibitor rival Zejula from GSK and Johnson & Johnson. J&J is working to gain an approval for Zejula in prostate cancer, but so far that drug is not cleared in this cancer.
In another bit of good news for AstraZeneca close to home, Imfinzi has been endorsed by the European Medicines Agency for the first-line treatment of patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy. The nod comes three months after the FDA signed off on the combo.