Amgen’s sNDA for expanded labeling of Kyprolis cancer drug granted priority review

The FDA will review Kyprolis in combination with dexamethasone for patients with relapsed multiple myeloma following prior treatment with at least one therapy, based on findings from the phase III ENDEAVOR trial.

Under the study, carfilzomib and dexamethasone reduced the risk of progression by 47% compared with bortezomib and dexamethasone.

The median progression-free survival (PFS) with carfilzomib was 18.7, when compared to 9.4 months with bortezomib.

In the phase 3 study, 929 patients were randomized to receive Kyprolis as a 30-minute infusion along with dexamethasone or bortezomib and dexamethasone.

Kyprolis was administered at a starting dose of 20 mg/m2 on days 1 and 2 of cycle 1.

If tolerated, the dose was increased to 56 mg/m2 on day 8 of cycle 1. After this point, the 56 mg/m2 dose was maintained on days 9, 15, and 16 and throughout the cycles.

In the control arm, patients received bortezomib at 1.3 mg/m2. Over 75% of the subjects received bortezomib subcutaneously.

Under the priority review program, the FDA will make a decision by 22 January 2016.

Amgen executive vice president of research and development Sean Harper said: "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.

"The acceptance of this submission is an important next step toward providing more options for patients with relapsed multiple myeloma and we look forward to working with the FDA over the coming months."

The most common adverse events occurring in about 20% of patients treated with Kyprolis in the combination therapy trial include decreased lymphocytes and absolute neutrophil count, reduced phosphorus, anemia, neutropenia, total white blood cell count, platelets, and several others.

Image: Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.