FDA Grants Priority Review for Amgen’s Myeloma sNDA

The US Food and Drug Administration (FDA) has granted priority review of Amgen's supplemental new drug application (sNDA) seeking label expansion for Kyprolis (carfilzomib), an injection therapy for treating multiple myeloma.

The expanded labeling would allow Kyprolis to be used in combination with dexamethasone on patients who have received at least one prior therapy. The FDA recently approved Kyprolis in combination with Celgene's Revlimid (lenalidomide), and dexamethasone for treating relapsed multiple myeloma.

Priority review is assigned to applications for drugs that could potentially treat serious conditions. The FDA's target action date for this application is January 22, 2016.

Source: Amgen

Leave a Reply

Your email address will not be published. Required fields are marked *