Johnson & Johnson Submits FDA Application for Multiple Myeloma Drug

Johnson & Johnson (NYSE: JNJ) subsidiary Janssen announced on Monday that it had filed a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for its multiple myeloma drug Darzalex (also known as daratumumab).

Strong results from the company's phase 3 Candor study showed that J&J's Darzalex in combination with two other drugs from Amgen, Kyprolis and dexamethasone, helped reduce the chance of cancer progression or death than Amgen's two drugs without Darzalex. Johnson & Johnson's new application will seek to expand the drug's approval to be used alongside Kyprolis and dexamethasone specifically for multiple myeloma patients who have failed to respond to traditional therapy (also known as refractory or relapsed multiple myeloma).

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