Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone is approved by FDA for use in patients ailing from relapsed multiple myeloma that has received two to three prior therapies including treatment with bortezomib (Velcade, Millennium).

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Kyprolis is positioned as second line therapy for use early in the course of the treatment unlike its initial approval back in July 2012 where it is used in treating multiple myeloma as a single drug in a subset of patients, according to San Francisco Business Times.

Sean E. Harper, MD, executive vice president of R&D at Amgen, said in a press release that "The expanded indication of Kyprolis provides patients with relapsed multiple myeloma a new therapeutic option, helping to address a real unmet need for this common blood cancer." He also added that "The approval of a second indication for Kyprolis in just 3 years demonstrates that it is becoming a critical component in the treatment of multiple myeloma, and underscores our commitment to advancing care for patients with this challenging disease," reported Healio.

The FDA has given the expanded approval based on the phase 3 ASPIRE trial that is presented in the American Society of Hematology Annual Meeting in December, 2014. According to the trial results lenalidomide and dexamethasone in combination with carfilzomib increased average progression free survival of multiple myeloma patients by 8.7 months.

It is observed in further researches that the treatment worked in all the subgroups except when the patient suffered higher tumor burden at baseline. The progression free survival among patients with stage 1 disease as per international staging system (ISS) was observed to be 11 months, progression free survival of ISS stage 2 was 8 months and that of patients with ISS stage 3 was 2 months.

FDA has noted that new label on Kyprolis carries warnings on acute renal failure, hypertension, VTE, pulmonary toxicities, cardiac toxicities and warning on mortality for aged patients. It also recommends the use of carfilzomib as a monotherapy as well as modification in the dosage as either carfilzomib alone or in the combination of lenalidomide and dexamethasone, according to Haelio. 

TagsKyprolis, Multiple Myeloma, Lenalidomide, Dexamethasone, Cancer