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Supplemental application seeks to add OS data to Kyprolis label for myeloma treatment
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The FDA accepted for review a supplemental new drug application that seeks to add data from a randomized phase 3 trial to the prescribing label for carfilzomib.
Carfilzomib (Kyprolis, Amgen), a proteasome inhibitor, is approved for use in combination with dexamethasone for treatment of patients with relapsed or refractory multiple myeloma who received one to three prior lines of therapy.
Amgen submitted a supplemental application that seeks to have OS data from the randomized phase 3 ENDEAVOR trial added to carfilzomib’s label.
The ENDEAVOR trial included 929 patients with myeloma whose disease relapsed after one to three prior therapeutic regimens.
Researchers randomly assigned patients to carfilzomib plus dexamethasone or bortezomib (Velcade, Takeda/Millennium) and dexamethasone.
Results showed the carfilzomib regimen significantly extended median OS (47.6 months vs. 40 months; HR = 0.79; P = .01).
Adverse events in among carfilzomib-treated patients in the ENDEAVOR trial appeared consistent with those previously reported.
The most common adverse events included anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache.
The FDA is expected to make a decision on the supplemental application by April 30, 2018.
“Effective proteasome inhibition is an essential approach to treating multiple myeloma,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a company-issued press release. “These data, along with compelling overall survival results from the phase 3 ASPIRE trial, clearly demonstrate that Kyprolis-based regimens should be considered new standards of care for appropriate patients with relapsed multiple myeloma.”