BRIEF—Amgen seeks label extension for Kyprolis

Amgen has filed a supplemental new drug application to extend use of Kyprolis (carfilmozib) to include a once-weekly dosage option when used as a dual therapy alongside dexamethasone.

The company is applying on the basis of results from the Phase III ARROW study, which included 478 patients and reported a similar safety profile to a twice-weekly Kyprolis regimen while achieving an average 3.6 months of progression-free survival more than that routine.

"I’m proud of our continued dedication to the Kyprolis clinical program, with a focus on generating additional data to reduce the dosing and administration burden on patients with relapsed or refractory multiple myeloma," said David Reese, executive vice president of R&D at Amgen.

"Data from the Phase III ARROW study illustrates Kyprolis’ potential to extend the time patients live without their disease progressing while also providing a more convenient once-weekly dosing option for this frequently relapsing and difficult-to-treat cancer. We look forward to working with the agency to bring this more streamlined dosing regimen to patients."