A Chat With The Makers Of New Colorectal Cancer Drug

Stivarga approved to treat advanced colorectal cancer

(RxWiki News) People living with colorectal cancer that has spread to other areas of the body now have a new therapy option. Unlike so many late-stage cancer treatments, this isn’t an intravenous drug - rather, a tablet.

The U.S. Food and Drug Administration has approved Stivarga (regorafenib) for people whose metastatic colorectal cancer has outfoxed all the other treatments available.

The medication extends life – what scientists call overall survival – by 29 percent or 1.4 months, compared to a placebo.

Stivarga also keeps the disease stable for longer – 2 months vs. 1.7 months on placebo.

Some background. About 144,000 Americans are diagnosed with colorectal cancer every year, and 52,000 don’t win their fight.

Standard of care – that is, the usual care people receive – includes chemotherapy and other medications to knock out the tumor’s ability to grow and spread.

It’s at this stage that Stivarga comes in – it’s the last house on the block so to speak.

dailyRx News asked executives at Bayer HealthCare Pharmaceuticals – the makers of Stivargo – if 1.4 more months wasn’t a fairly small benefit.

Shannon Campbell, Bayer Vice President and General Manager of Oncology, told us in a telephone interview, “I think you need to look at where these people are in terms of their care. We’re looking at people in the later stages of their disease, where they’ve already gone through standard therapies. When you look at it, it’s still a 29 percent improvement in overall survival.”

Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs at Bayer. said, “I think it’s very important to realize that Stivargo is approved in an area where there are no other approved therapies.” 

Dr. Cyrus says the fact that Stivarga comes in pill form also makes a difference. Rather than the common infusion drugs, this oral medication will be easy to take. "And that makes a difference in people’s lives," she said.

dailyRx News asked how much this drug costs. At wholesale – without pharmacy mark-up – it costs $9,350 for a 28-day supply, Campbell told us.

Bayer Healthcare’s REACH program is available to support patients who cannot afford the cost of this medication.

This medication was approved after the company’s international Phase III trial which involved 760 patients. People taking Stivarga lived a median of 6.4 months, compared to the 5 months people taking a placebo lived.

The most common Stivarga side effects include fatigue, decrease in appetite, skin reactions on hands and feet, diarrhea, weight loss, high blood pressure and infection, among others.

Severe side effects can include bleeding in the liver, hemorrhage and perforation (holes) in the gastrointestinal system.

Stivarga was developed by Bayer, which has partnered with Onyx Pharmaceuticals. The two companies will jointly market the drug in the U.S.

Review Date: 
September 26, 2012