logo
Share SHARE
FONT-SIZE Plus   Neg

Onyx's Kyprolis Gets FDA Approval For Multiple Myeloma, Shares Up 5%

US Food and Drug Administration granted accelerated approval for Onyx Pharmaceuticals Inc.'s (ONXX) Kyprolis for treatment of patients with multiple myeloma who have received at least two prior therapies. Following the news, shares of Onyx Pharmaceuticals rose over five percent on the Nasdaq.

Kyprolis, whose chemical name is Carfilzomib, is a next-generation proteasome inhibitor, belonging to the same class as Takeda Pharmaceutical Co.'s multiple myeloma treatment Velcade.

The FDA approved Kyprolis for treatment of patients who failed to successfully treat their blood cancer with at least two medicines, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

The indication for Kyprolis is based on response rate. Currently, no data are available for Kyprolis that demonstrate an improvement in progression-free survival or overall survival.

Multiple myeloma is a type of blood cancer, and an estimated 200,000 people worldwide are living with this disease. In the U.S, about 50,000 people are affected by multiple myeloma, and 20,000 new cases are diagnosed each year. Onyx sees over $2 billion global sales opportunity in multiple myeloma.

Chief Exective Anthony Coles said, "Today's approval is a significant milestone for Onyx and, most importantly, for patients with advanced myeloma who have few treatment options available to them."

The approval was based on the results of the Phase 2b 003-A1 study, a single-arm, multicenter clinical trial that enrolled 266 patients with multiple myeloma. The overall response rate was 22.9 percent and median response duration was 7.8 months.

Onyx shares is currently trading at $71.95, up $3.55 or 5.19%, on a volume of 1.7 million.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Media and entertainment giant Walt Disney Co. said Tuesday that Christine McCarthy, the company's Treasurer for the past 15 years, will succeed James Rasulo as Chief Financial Officer. A blast at the Al-Imam al-Sadeq mosque in Kuwaiti capital killed eight people. Several people were wounded in the explosion, probably a suicide bombing, after the Friday prayers. Many are said to be in critical condition. One was killed in a probable ISIS attack at U.S. based Air products and Chemicals' industrial site in France. According to media reports, a car disguised as a delivery vehicle was rammed into Air product site in Schiltigheim, Southeast France. Police arrested a young man of around 30 years old, who is suspected to have connections with Islamic State.
comments powered by Disqus
Follow RTT