FDA moves to curb Avastin's approval for breast cancer

The Food and Drug administration on Thursday revoked its approval of Roche drug Avastin for the treatment of breast cancer. The agency's action, based on findings that did not confirm that the medicine helped patients with this disease, has drawn criticism from patients and politicians.

The Fiscal Times: FDA Chooses Science Over Politics
In the end, science, not politics, prevailed. The Food and Drug Administration announced Thursday that it plans to withdraw its conditional approval of Genentech's Avastin for treatment of metastatic breast cancer. The agency had been under intense pressure to grant permanent approval by the company, by some patient advocacy groups and conservatives on Capitol Hill who accused the agency of wanting to "ration" Avastin. An outside advisory panel that carefully weighed the evidence last July concluded by a 12-1 vote that the drug's risks, which include serious side effects like internal bleeding, hypertension and vascular perforations, did not outweigh its benefits. Still, Genentech, a unit of Roche, immediately announced yesterday that it would demand another hearing to present new data that might convince the FDA to rethink its decision (Goozner, 12/16).

The Washington Post: FDA Moves To Revoke Avastin's Approval For Breast Cancer
Federal regulators took the unusual step Thursday of moving to revoke approval of a drug that women with advanced breast cancer turn to in a last-ditch effort to save their lives (Stein, 12/17).

The New York Times: FDA Rejects Use Of Drug In Cases Of Breast Cancer
The Food and Drug Administration on Thursday moved to revoke the approval of the widely used drug Avastin as a treatment for breast cancer, saying that new studies did not confirm that the medicine was helping patients (Pollack, 12/16).

Los Angeles Times: FDA Moves To Revoke Approval Of Avastin For Treatment Of Breast Cancer
The Food and Drug Administration on Thursday moved toward revoking approval of the blockbuster cancer drug Avastin as a treatment for breast cancer, drawing criticism for limiting treatment options for desperately ill women (Zajac, 12/16).

The Wall Street Journal: Roche Drug Faces FDA Curb
In a move that drew protests from patients and politicians, the Food and Drug Administration said it plans to revoke approval of the drug Avastin for breast cancer because it doesn't believe that the medicine helps patients who have the disease (Mundy, 12/17).

The Associated Press: FDA: Avastin Should Not Be Used For Breast Cancer
Federal health authorities recommended Thursday that the blockbuster drug Avastin no longer be used to treat breast cancer, saying recent studies failed to show the drug's original promise to help slow the disease and extend patients' lives (Perrone, 12/16).

Bloomberg: Roche's Avastin Faces FDA Withdrawal In Breast Cancer
Roche Holding AG's top-selling drug Avastin should no longer be used to treat breast cancer after recent studies failed to show a benefit, U.S. regulators said (Larkin and Kresge, 12/16).

Reuters: U.S. and Europe Seek Limits On Roche's Avastin
Roche's top drug Avastin should no longer be approved for breast cancer, U.S. health officials said on Thursday in an unusual move that could shave $1 billion from annual sales (Richwine and Hirschler, 12/16).

PBS NewsHour: FDA: Avastin Does Not Work For Breast Cancer Treatment
The Food and Drug Administration said Thursday that it is beginning the process of revoking approval for the drug Avastin for use in the treatment of breast cancer. In a statement, the agency said that four independent trials have shown that Avastin does not increase life expectancy for breast cancer patients and that it has serious side effects, including high blood pressure, bleeding and hemorrhaging, holes in the intestines and stomach, and heart failure (Winerman, 12/16).

---

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.