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Amgen Submits SNDA For KYPROLIS - Quick Facts


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(RTTNews.com) - Amgen ( AMGN ) announced the submission of a supplemental New Drug Application or sNDA to the U.S. Food and Drug Administration to expand the Prescribing Information for KYPROLIS or carfilzomib to include a once-weekly dosing option in combination with dexamethasone or Kd for patients with relapsed or refractory multiple myeloma.

The sNDA is based on data from the Phase 3 A.R.R.O.W. trial, demonstrating KYPROLIS administered once-weekly at 70 mg/m2 with dexamethasone (once-weekly Kd) achieved superior progression-free survival or PFS and overall response rates (ORR), with a comparable safety profile versus the twice-weekly KYPROLIS at 27 mg/m2 and dexamethasone (twice-weekly Kd).

The FDA is reviewing the application under the Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

The overall safety profiles of the two arms were comparable, with no new safety risks identified in the once-weekly arm. The most frequently reported treatment-emergent adverse events (greater than or equal to 20 percent) in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia.


Read the original article on RTTNews (http://www.rttnews.com/2929681/amgen-submits-snda-for-kyprolis-quick-facts.aspx)


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Referenced Symbols: AMGN



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