FDA Approves Onyx Cancer Drug

BY RON WINSLOW AND SAABIRA CHAUDHURI

Onyx Pharmaceuticals Inc. said the U.S. Food and Drug Administration approved its drug carfilzomib for a form of blood cancer called multiple myeloma, providing a new option for a disease that afflicts nearly 22,000 new patients in the U.S. a year.

The agency cleared the drug, known by the brand name Kyprolis, largely on the basis of a single 266-patient study, under the agency’s accelerated approval program that is intended to provide patients with earlier access to especially promising new drugs.

The approval is for patients who have relapsed on at least two prior treatments, including Takeda Pharmaceutical Co.’s Velcade …