FDA Authorizes New Drug for Breast Cancer

The Food and Drug Administration on Thursday approved a new breast cancer drug for people whose disease has spread to the lymph nodes.

The drug, when used after surgery with two other standard drugs, appears to significantly improve survival over another common regimen. But it also carries the risk of more side effects than the other treatments, a factor that raises the inevitable difficult choices patients and their physicians face in making breast cancer treatment decisions.

The drug, epirubicin, sold under the brand name Ellence and made by Pharmacia & Upjohn Inc. of Kalamazoo, Mich., showed a “significant” difference in the length of time women survived without a recurrence of breast cancer and an increased five-year overall survival rate in two long-term studies of 1,200 patients, the FDA said.

These women, however, suffered more nausea, vomiting and hair loss, as well as a higher rate of serious infections, some resulting in hospitalization. Also, the drug poses a small risk of irreversible heart damage, as well as leukemia, a long-term consequence of some chemotherapy agents.

Many breast cancer patients opt for chemotherapy after surgery, even in cases in which the cancer has not spread to the lymph nodes. And experts pointed out that many of these agents produce nasty side effects.

“They all do,” said Joann Schellenbach, a spokeswoman for the American Cancer Society. “But if there is a new regimen that is more effective than an old one--if it gives oncologists another choice--that is good news.”

Diane Balma, senior legal counsel for the Susan G. Komen Breast Cancer Foundation--herself a breast cancer survivor--agreed.

“What may be right for one woman may not be right for another,” she said. “Different women react differently to different chemotherapy. It’s a highly individualistic disease, and each treatment decision is an individual one.”

Another drug for post-surgical breast cancer chemotherapy soon could move closer to FDA approval. An FDA advisory committee today is scheduled to review research data on the use of Taxol, a drug already in use against other cancers.

There are about 180,000 cases of breast cancer diagnosed annually and an estimated 75,000 of them need chemotherapy after surgery, according to Pharmacia & Upjohn.

For post-surgical chemotherapy, physicians typically choose between two combinations of drugs. One is called AC, containing the drugs adriamycin and cyclophosphamide. The other is called CMF, and contains cyclophosphamide, methotrexate and fluorouracil.

In the studies that led to Thursday’s action, Ellence was substituted for the methotrexate in the CMF combination and tested against the original CMF.

After five years, fewer Ellence group patients had suffered a cancer recurrence. In fact, 62% of the women treated with Ellence survived without a relapse, compared with 53% of the women who took the drug combination without it.

Also, fewer patients in the Ellence group died over the five-year period. The overall five-year survival rate was 77% of the Ellence group, compared with 70% in the other group.

In a second study, the Canadian researchers found that patients given a higher dose of Ellence as part of their regimen fared better than those given lower doses of it.

Sixty-five percent of the patients in the high-dose group survived without a recurrence, compared with 52% of the low-dose group. Similarly, 76% of the high-dose group survived over five years, compared with 65% of the women taking the lower dose.

The drug “could help save the lives of thousands of women,” said Carrie Smith Cox, a senior vice president of Pharmacia & Upjohn.

Ellence will be available in mid-October and will cost a patient about $12,000 for a six-month course, the company said.