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The first four sites where colorectal cancer patients can get regorafenib are now open.  Bayer Healthcare expects to open additional sites in the next two or three weeks.

Colorectal cancer patients whose cancer has gotten worse on all standard treatments can now be considered for the Regorafenib Extended Access program.

Bayer Healthcare has applied for FDA approval of regorafenib to treat colorectal cancer, but until it is actually approved and on the market, the expanded access program is the only way patients who might benefit can receive it.

Last fall, early results from the randomized Phase 3 CORRECT clinical trial showed colorectal cancer patients who received regorafenib lived longer than a similar group who got a placebo. Read the rest of this entry »

In an effort to broaden and clarify access by individual patients to experimental medicines that have not yet obtained FDA approval or haven’t been approved for a new use, the Food and Drug Administration issued two new rules on August 12, 2009.

• The Expanded Access rule establishes how seriously ill individual patients or groups of patients can obtain investigational medicines while at the same time preserving the clinical trials process.
• The Charging rule clarifies when a manufacturer of an investigational drug may charge for it and what costs can be recovered in those charges.

In addition, the FDA established a website for consumers to explain access to investigational drugs through clinical trials or through the expanded access process. Read the rest of this entry »