Skip to NavigationSkip to content

FDA approves new Kyprolis combo for multiple myeloma

Published on 22/01/16 at 09:24am
Amgen image

Amgen’s Kyprolis has been given another endorsement by the FDA as a multiple myeloma treatment – its second in six months.

The latest green-light means that Kyprolis (carfilzomib) injection can be used in the US in combination with dexamethasone, or with Celgene’s Revlimid (lenalidomide) plus dexamethasone, to treat patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.

"Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs," says Sean Harper, executive vice president of research and development at Amgen. "Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer."

"Multiple myeloma remains an incurable disease where relapse inevitably occurs and over time patients become resistant to treatments," says Dr Ruben Niesvizky, director of the multiple myeloma centre at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Centre. "As a clinician, I'm pleased with the tremendous progress that we have seen in the past 12 months in multiple myeloma treatment. This FDA approval is important because it provides physicians with flexible options for Kyprolis use in helping to manage this challenging disease."

This new indication for Kyprolis is the second in six months. In July 2015, the FDA approved another expanded indication for Kyprolis in combination with Revlimid and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.

Lilian Anekwe

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches