FDA revokes breast cancer approval for Avastin
SILVER SPRING, Md. — A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.
The FDA announced that it would revoke the agency’s approval of Genentech’s Avastin (bevacizumab) for breast cancer. The drug’s approval for cancers of the colon, lungs, kidney and brain will remain in place. The agency proposed withdrawing the approval in December 2010, just months after an advisory committee recommended limiting its use for breast cancer, after reviewing results from four clinical studies indicating that the drug "does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients."
"This was a difficult decision," FDA commissioner Margaret Hamburg said. "FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use."
The agency approved Avastin for breast cancer that had spread to other parts of the body in February 2008, under the agency’s accelerated approval program. But Friday’s decision, based on thousands of pages from a public docket, from clinical trials and from a two-day hearing in June — scheduled at the request of Genentech when the company was informed that the agency was considering revoking the breast-cancer approval — resulted in the FDA’s Oncologic Drugs Advisory Committee voting unanimously in favor of withdrawal.
FDA approves Erwinaze for acute lymphoblastic leukemia
SILVER SPRING, Md. — The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.
The FDA announced the approval of EUSA Pharma’s Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with ALL who have developed an allergy to E. coli-derived asparaginase and pegaspargase chemotherapy drugs.
The drug is injected directly into the muscle three times a week and works by breaking down asparagine, an amino acid that is present in the blood and is necessary for cell growth. Leukemia cells can’t produce asparagine, so they die when the patient receives the drug. But normal cells, which can produce enough of the amino acid on their own, are not affected.
NACDS RxImpact Day pushed back due to congressional schedule
ALEXANDRIA, Va. — The National Association of Chain Drug Stores has announced that the dates of the 2012 NACDS RxImpact Day on Capitol Hill in Washington, D.C., have been changed because of an alteration in the 2012 congressional calendar. The new dates for the two-day pharmacy advocacy event will be March 21 and 22, 2012.
The event was previously scheduled for the prior week in March, which now falls during a congressional district work period in which members of Congress will be in their home states and districts.
“There is much at stake with the healthcare delivery system today, and its imperative that pharmacy advocates engage with their elected officials during their visit to Washington, D.C. The rescheduling of the two-day event to March 21 and 22 will now enable pharmacy advocates from across the country to engage with lawmakers on pro-patient and pro-pharmacy issues,” explained NACDS president and CEO Steve Anderson. “In its fourth year, this high-energy event will bring together advocates from all sectors of the industry to meet with key lawmakers to illustrate the unsurpassed value of community pharmacy in improving patient health and reducing costs.”
NACDS will mobilize hundreds pharmacy advocates from all across the country — many wearing pharmacy white coats — during the fourth annual NACDS RxImpact Day on Capitol Hill. The event brings pharmacy and retail executives, division and store managers, pharmacists, pharmacy school deans and students to Washington, D.C., for the two-day event.