US regulators will undertake a speedy assessment of Amgen’s request to expand the scope of its cancer jab Kyprolis in patients with relapsed multiple myeloma.
The firm has filed a supplemental New Drug Application for Kyprolis (carfilzomib) seeking approval for its use alongside dexamethasone in patients who have received at least one prior therapy.
The drug is already available in the US in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone to treat relapsed MM in patients who have received one to three prior lines of therapy.
The need for new treatment options is particularly urgent for patients with the blood cancer, as each time they relapse their prognosis worsens significantly.
"Clinicians need a range of options and robust clinical data to make informed choices that can ideally extend the time patients live without their cancer progressing," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
The application is based on data from the Phase II head-to-head ENDEAVOR study, in which patients given Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening compared to those taking Janssen’s Velcade (bortezomib) and low-dose dexamethasone (median progression-free survival 18.7 months versus 9.4 months, respectively).