February 6, 2023
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Amgen submits data on cancer drug Kyprolis to FDA


Thousand Oaks-based Amgen announced Thursday that it submitted data comparing its new multiple-myeloma drug against a rival to the Food and Drug Administration.

Kyprolis is Amgen’s new treatment for multiple-myeloma, which is a form of blood cancer that forms in plasma cells and typically grows in bone marrow. The drug was approved for third-line treatments in 2012, and could be approved for second-line treatments by the FDA on July 26.

According to the American Cancer Society, 27,000 Americans will be diagnosed with multiple-myeloma in 2015, and 11,000 will die from the disease. Data Amgen submitted to the FDA was about a study which pitted Kyprolis in a first line treatment against rival drug Velcade, which is made by Takeda Pharmaceuticals.

In March, Amgen announced that the study showed patients who took Kyprolis had a progression-free survival rate of about 19 progression-free months, compared to about nine months for Velcade. Amgen said in a news release Thursday that overall survival-rates for patients in the study were not mature yet, and will be continued to be monitored.

“If approved, it will mean more treatment options for patients with this serious disease,” said Sean Harper, executive vice president of research and development at Amgen, in a news release.

“Multiple myeloma has historically been one of the most difficult to treat diseases because of the inherent complexities related to the recurring pattern of remission and relapse.”

Like many recent Amgen drugs, Kyprolis has been criticized for its high cost. Kyprolis typically costs $10,000 per 28-day cycle.

Critics of the study have pointed out that patients were given twice the FDA approved dose of Kyprolis.

By filing the data with the FDA, Amgen did not say if it is asking for the treatment to be cleared for first line use. Rather, Amgen just said that it is seeking expanded use for Kyprolis. Amgen did say that death rates due to adverse effects were similar to those of another study, which was submitted to the FDA for second-line use consideration.