FDA expands approval of Bayer cancer drug (Update)

The U.S. Food and Drug Administration on Monday expanded approval of a Bayer cancer pill to treat tumors of the intestinal tract that do not respond to other treatments.

The drug is called Stivarga and regulators approved it to treat gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other FDA-approved drugs.

The FDA previously approved Stivarga to treat colorectal cancer. It works by blocking several enzymes that promote cancer growth.

The FDA approved the drug for the new use based on a study of nearly 200 patients who were randomly assigned to take Stivarga or a placebo pill.

Patients taking the drug experienced a nearly four month delay in the growth of their tumors compared to taking placebo.

The most common side effects of Stivarga in clinical trials included liver damage, severe bleeding, blistering and peeling of skin, high blood pressure, heart attacks and perforations.

Other drugs approved to treat intestinal tumors include Gleevec, from Novartis, and Sutent, made by Pfizer Inc.

Bayer HealthCare is a subsidiary of Germany's Bayer AG.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

New drug overcomes resistance in patients with rare sarcoma

Nov 21, 2012

A new targeted drug demonstrated its ability to control metastatic gastrointestinal stromal tumor, an uncommon and life-threatening form of sarcoma, after the disease had become resistant to all existing therapies, report ...

Gleevec's latest approval is for pediatric cancer

Jan 25, 2013

(HealthDay)—The anti-cancer drug Gleevec (imatinib) has received new U.S. Food and Drug Administration approval to treat the most common type of pediatric cancer, affecting some 2,900 children each year, the agency said ...

FDA panel backs Pfizer drug for kidney cancer

Dec 07, 2011

(AP) -- A panel of advisers to the Food and Drug Administration voted Wednesday that the benefits of a Pfizer kidney cancer drug outweigh its risks, according to a company spokeswoman.

Recommended for you

FDA proposes accelerated medical device approval plan

12 hours ago

(HealthDay)—The U.S. Food and Drug Administration has proposed a new program that would provide expedited access to high-risk medical devices intended for patients with serious conditions whose medical ...

Targeting drugs to reduce side effects

17 hours ago

(Medical Xpress)—Consider ice cream – the base of which is frozen cream. Ingredients are then added to make different flavours. All these flavours are distinctly different but are created from the same foundation.

User comments