January 28, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Biopharmaceutical company Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., announced on Jan. 27 that they have submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency for Kyprolis. The product, which is also known as carfilzomib, is designed to treat patients who have relapsed multiple myeloma and have received at least one therapy.
The sNDA and MMA are based on data from a Phase III study titled ASPIRE, which looked at how carfilzomib, lenalidomide, and dexamethasone affected patients compared to lenalidomide and dexamethasone.
“Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing,” said Pablo Cagnoni, president of Onyx Pharmaceuticals, Inc. “The U.S. and E.U. submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma.”
The goal of the sNDA is to expand the current approved indication, as well as support the conversion of accelerated approval to full approval. In the E.U., Kyprolis has received orphan drug designation.
Multiple myeloma is the second most common hematologic cancer. It results from an abnormality of the plasma cells, typically within the bone marrow. Approximately 230,000 people are living with the disease around the world.
FOCUS Trial Results
In August 2014, Onyx Pharmaceuticals, Inc., and Amgen announced that Kyprolis did not meet its primary endpoint in improving overall survival in the FOCUS Phase III clinical trial.
“While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase III clinical trial will be sufficient to support regulatory submissions around the world,” said Cagnoni, at the time of the announcement.
In the FOCUS study, Kyprolis was compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide. The secondary endpoints of the study were progression-free survival, overall response rate, clinical benefit rate, and duration of response and safety.
In 2012, the FDA granted accelerated approval of Kyprolis in patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent.
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