Amgen blood cancer drug succeeds in late-stage study
Amgen Inc said a late-stage study found that its blood cancer drug helped patients live significantly longer without the disease worsening, compared with standard treatment.
The world's largest biotechnology company's shares rose as much as 4.3 percent to $131.00 in premarket trading, after it released interim data for its injectable drug, Kyprolis.
The U.S. Food and Drug Administration, in 2012, granted the drug accelerated approval for use in multiple myeloma, the second most common form of blood cancer.
Accelerated approval is granted to drugs for serious diseases with little or no treatment options, based on data from initial trials. However, manufacturers still need to conduct larger trials to bolster initial findings.
The trial tested Kyprolis in combination with two other treatments, against those two treatments alone, in 792 patients with relapsed multiple myeloma who have received prior therapy.
Patients treated with Kyprolis lived for a median of 26.3 months without disease progression, compared with 17.6 months for those not given the drug, Amgen said.
The data may support the conversion of accelerated approval to full approval and help the company expand the current indication in the United States, Amgen said.
Amgen shares were up 3.14 percent at $129.50 in premarket trading on the Nasdaq on Monday.
Kyprolis, the centerpiece of Amgen's nearly $10 billion acquisition of Onyx Pharmaceuticals last year, had sales of $68 million in the first quarter.