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Amgen Announces FDA Approval of Kyprolis In Combination With Other Drugs



© Reuters.

By Sam Boughedda

Investing.com — Amgen Inc (NASDAQ:) announced Wednesday that the U.S. Food and Drug Administration has approved the use of its Kyprolis drug in combination with others to treat adult patients with relapsed or refractory multiple myeloma.

The FDA approved it in combination regime with Darzalex Faspro and dexamethasone.

Shares of the biotech firm are currently trading over 2.7% higher.

Amgen said the prescribing information expansion was supported by the ongoing, phase 2 trial. The study is evaluating the benefit of Darzalex Faspro given in combination with four standard-of-care treatment regimens.

“I am pleased that the addition of subcutaneous daratumumab to KYPROLIS plus dexamethasone will offer increased flexibility and convenience for patients with relapsed or refractory multiple myeloma and will greatly reduce the administration burden,” stated David M. Reese, executive vice president of Research and Development at Amgen. 

According to the company, serious adverse reactions occurred in 27% of patients who received Kyprolis combined with Darzalex Faspro and dexamethasone.

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