Evista gets ODAC nod to prevent breast ca

August 1, 2007

ROCKVILLE, Maryland—Despite the concerns of some members of the Oncologic Drugs Advisory Committee (ODAC) and the opposition of several advocacy groups, the panel recommended that the Food and Drug Administration approve two cancer-related indications for Evista (raloxifene), Eli Lilly's selective estrogen-receptor modulator (SERM).

By a vote of 8 to 6 with one abstention, ODAC supported marketing approval for the drug's use for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis, and by a 10-to-4 vote with one abstention, for reducing the risk of invasive breast cancer in postmenopausal women at high risk of breast cancer.

FDA previously approved Evista for the prevention and treatment of osteoporosis in postmenopausal women. The need for a separate breast cancer prevention indication for women with osteoporosis puzzled some committee members. "I don't understand, really, what is to be gained by the first indication," said Michael Link, MD, professor of pediatrics and chief of hematology/oncology at Stanford University School of Medicine.

"It's a very competitive environment," replied Richard Pazdur, MD, director of FDA's Office of Oncology Drug Products, a remark that drew a hearty laugh from the committee and audience.

The meeting was also punctuated by a rare rebuke to patient advocates from a member of the panel (see box), and questions about whether at-risk women will accept Evista as a preventive agent at a higher rate than they have tamoxifen(Drug information on tamoxifen).

The relatively low usage of of tamoxifen since FDA approved the drug for reducing the risk of breast cancer in high-risk women has generally been attributed to the concerns of women about the risks of endometrial cancer and thrombolic adverse events associated with its use.

RUTH, STAR, and MORE/CORE

To support its New Drug Application, Lilly presented data from three placebo-controlled trials and the active-control Study of Tamoxifen and Raloxifene(Drug information on raloxifene) (STAR) trial, which was conducted without a placebo arm. "The most important data supporting the proposed new indications come from the RUTH [Raloxifene Use for the Heart] and STAR trials," Dr. Pazdur told the committee members.

Pages: 1 2 3

Brawley to advocates: 'Look at the facts'

During the public hearing portion of the meeting, representatives of Breast Cancer Action, the National Breast Cancer Coalition Fund, and the Women's National Health Network opposed recommending Evista's approval as a cancer preventive. Their reasons echoed many of the concerns voiced by ODAC members.

"Research on products that lower the risk of breast cancer have been problematic in three major areas—lack of long-term follow up for safety, lack of placebo in some studies, and misleading reporting of findings," said Jane Zones, of Breast Cancer Action. Ms. Zones stated her belief that in NSABP P-1 (the pivotal trial for approval of tamxoifen as a breast cancer preventive), the investigators changed the primary endpoint from overall survival to breast cancer incidence. She also challenged the use of relative risk in reporting differences in breast cancer incidence in prevention trials as giving an exaggerated sense of the drug's efficacy.

After ODAC resumed its regular session, Otis Brawley, MD, professor of hematology/oncology and medicine at Emory University, criticized some of these remarks. "I've heard from the advocates a couple of things that are just out and out wrong—first, that the NSABP P-1 trial was initially designed as a survival trial and was changed to an incidence-based trial," he said. "That is totally wrong." He added that "reduction of period prevalence, that is, reduction of risk over the period in which the person is taking the drug, is accepted by epidemiologists as being prevention." Finally, he said that "we need to stop and slow down. One of the advocates said we need to stop exaggerating. I think they need to stop exaggerating and look at the facts."

TOPIC INDEX

Cancer Types
Breast Breast (HER2+) Breast (Triple-Negative) CML Colorectal Gastrointestinal GIST Genitourinary Gynecologic Head & Neck	Hematology Kidney (Renal Cell) Leukemia Lung Lymphoma Melanoma Multiple Myeloma Ovarian Prostate Sarcoma
Supportive Care	More Topics
Bone Metastases End-of-Life Care Palliative Care	Ethics in Oncology Practice Management Practice & Policy

All Topics

FROM PHYSICIANS PRACTICE

Five Steps to Improving Patient Access
Judy Capko, May 21, 2013
Patient access is getting increased attention through reform initiatives. Here are five steps you can take to make sure patients get appropriate access to care in your office.

Growing HIPAA Threat – Ignore Windows XP at Your Own Peril
Marion K. Jenkins, May 21, 2013
Chances are good that you have some major ticking software time bombs lurking in your medical practice's computer environment, namely Windows XP and Server 2003.

Finding Physician Work-Life Balance in the Small Moments
Jennifer Frank, MD, May 21, 2013
At my practice and at home, things are always busy. There's laundry or homework, or a patient with needs.

Three Areas to Reduce Costs at Your Medical Practice
Greg Mertz, May 19, 2013
By taking a hard look at reducing costs for staffing, overhead, and technology at your medical practice, you may see increased physician compensation.

Dos and Don’ts for Starting a Physician Blog
Michael Woo-Ming, MD, May 18, 2013
Starting a physician blog can provide your medical practice with marketing benefits, but it's important to do it right.

Evista gets ODAC nod to prevent breast ca

Join the Conversation