Side effects include
Shares of Onyx Pharmaceuticals soared after winning support from a U.S. advisory panel for its drug to treat a deadly blood cancer that affects 50,000 Americans. The panel of independent experts advising the U.S. health regulator unanimously voted to recommend approval of Onyx’s drug Kyprolis for blood cancer patients who did not respond to other medicines, including Takeda Pharmaceutical’s Velcade and Celgene’s (CELG) Revlimid or Thalomid.
The medicine, with the proposed name Kyprolis, shrunk tumors in 22% of multiple myeloma patients, which may not offer enough of an advantage in light of the side effects, FDA staff said in a June 18 report. The positive vote was surprising as FDA staff had raised questions about the drug’s safety earlier in the week, citing serious heart, lung and liver side effects, while five patients died from heart ailments. Multiple myeloma is a type of cancer that affects the plasma cells in bone marrow. About 20,000 patients are diagnosed in the U.S. with myeloma each year, and about 10,000 die from it, according to the American Cancer Society.
Ligand Pharmaceuticals (LGND), which has an agreement with Onyx to explore an IV version of the medicine, increased as well. A final FDA decision is expected by July 27.
Onyx Pharma (ONXX : NASDAQ : US$63.78), Net Change: 19.20, % Change: 43.07%, Volume: 22,656,543
