After Clovis Oncology’s Rubraca snagged an FDA boost in prostate cancer last week, AstraZeneca and Merck’s rival Lynparza has matched it with a boost of its own.
The FDA bestowed its priority review designation on the PARP inhibitor for previously treated patients with metastatic, castration-resistant prostate cancer with certain genetic mutations, setting the drug up for an approval in the second quarter of this year, the companies said Monday.
Regulators based the decision on data from a phase 3 trial presented at last year’s European Society for Medical Oncology annual meeting showing that among those patients, Lynparza could slash the risk of disease progression or death by 66%.
Men with BRCA1, BRCA2 or ATM mutated cancers went a median 7.4 months without their cancer worsening, versus just 3.6 months for those treated with next-gen therapies such as Johnson & Johnson’s Zytiga or Pfizer and Astellas’ Xtandi, results from the trial—dubbed Profound—demonstrated.
“This is, I think, a game-changer,” Roy Baynes, M.D., Merck SVP and head of global clinical development, said at the time, noting that Lynparza “could easily become a new standard of care” in patients with one of those three gene mutations or any others in homologous recombination repair (HRR) genes.
But Lynparza, which has beaten Rubraca and Zejula from GlaxoSmithKline’s Tesaro into the ovarian cancer, breast cancer and pancreatic cancer markets, isn’t the only drug in its class in line for a speedy U.S. prostate cancer review. Just last week, the FDA tagged Rubraca for a priority review of its own, committing to hand down a decision on the Clovis product by May 15.
Meanwhile, the FDA’s move keeps the regulatory momentum going for Lynparza, which only just snagged its pancreatic cancer go-ahead late last month. That approval came despite concerns from an FDA advisory panel about the companies’ trial size and the limitations of imaging technology to accurately measure tumors.