European regulators have approved a new second-line treatment option for patients with advanced kidney cancer.
Exelixis' Cabometyx (cabozantinib) has been cleared for use in patients with advanced renal cell carcinoma (RCC) following prior vascular endothelial growth factor (VEGF)-targeted therapy.
The drug was given an accelerated assessment by the European Medicines Agency and is the first to show in a Phase III trial "robust and clinically meaningful improvements in all three key efficacy parameters - overall survival (OS), progression-free survival (PFS) and objective response rate (ORR)," according to the firm.
The METEOR study met its primary endpoint by significantly improving PFS; compared with Novartis' Afinitor (everolimus), the drug was associated with a 42 percent reduction in the rate of disease progression or death, with median PFS 7.4 months versus 3.8 months for Afinitor.
Cabometyx also significantly improved the objective response rate compared to Afinitor, be it through investigator assessment (24 percent versus 4 percent) or through central review (17 percent versus 3 percent).
"This marketing authorisation helps address an unmet medical need in Europe by providing patients with a new therapy that slows disease progression and prolongs overall survival," said Michael Morrissey, Exelixis' president and chief executive officer. "We look forward to further examining the use of Cabometyx in earlier lines of therapy and in other difficult-to-treat cancers."
The approval also triggers a $60 million milestone payment from French drugmaker Ipsen, which picked up certain rights to cabozantinib - outside the US, Canada and Japan - earlier this year.
The drug is already approved in Europe for under the brand-name Cometriq for the treatment of adult patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer.
Cabozantinib suffered a high profile failure in a Phase III prostate cancer trial back in 2014, but has been making a comeback ever since.