By Mary Welch
A sales force of several hundred will be knocking on the doors of obstetricians, gynecologists and family practitioners today as marketing begins for Nolvadex (tamoxifen citrate) for the reduction of breast cancer in high-risk women.
Nolvadex, developed by Wilmington, Del.-based Zeneca Pharmaceuticals Inc., is the first and only drug to be approved to decrease the incidence of breast cancer. In its actions announced late last week, the FDA also approved the drug for the reduction of contralateral (in the opposite breast) breast cancer.
"We just signed a co-promotion deal with Roche Laboratories (of Nutley, N.J.) where Roche's sales force will be used to expand our educational efforts to primary care and ob-gyn physicians as well as oncologists and surgeons," Steve Lambert, director of communications for Zeneca, told BioWorld Today. "There will be several hundred salespeople out there going one-on-one to help educate doctors in accessing patient risk. Many physicians are not familiar with Nolvadex, so there is a lot of work to be done on educating women and doctors on the appropriate use of Nolvadex."
The FDA approval was based on results announced in April from the Breast Cancer Prevention Trial that was conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and sponsored by the National Cancer Institute (NCI). That trial concluded that women taking Nolvadex reduced their incidence of developing invasive breast cancer on average by 44 percent.
Updated results released in September concluded that the incidence of invasive breast cancer was reduced by 44 percent in women ages 35-49, 51 percent for women between 50-59, and 55 percent for all women aged 60 and over. A reduction in the incident of breast cancer was evidenced in all age groups starting as early as the first year of treatment and continuing through six years' follow-up (for those who started the trial in 1992). The median follow-up was 4.2 years.
Currently Nolvadex is used as an adjuvant treatment following therapy for breast cancer to help prevent re-occurrence. It has been on the market for more than 20 years as a hormonal agent, and Zeneca said Nolvadex is the most prescribed hormonal treatment for breast cancer in the world.
With the new FDA ruling, women who are likely to get breast cancer can get the drug to lessen those chances. "Potentially there is a world market of 29 million women," said Lambert. "But we, and the National Cancer Institute, have worked up a risk development assessment — a numerical value based on a variety of issues — that will help women and doctors determine if Nolvadex is appropriate for them."
Among those risk factors are: age, number of first-degree relatives with breast cancer, previous breast biopsies with or without atypical hyperplasia, age at first live birth, age at first menstrual period, and women with a history of lobular carcinoma in situ (LCIS).
Lambert admits that the FDA's second new indication is almost semantic. "It confirms, to a degree, what other physicians are already using it for — to prevent the occurrence of the disease."
Zeneca Pharmaceuticals is a business unit of Zeneca Inc., of Wilmington, Del., which in turn is a wholly-owned subsidiary of the London-based Zeneca Group Plc. Roche Laboratories Inc., is a member of the Roche Group, based in Basel, Switzerland.
Zeneca's stock (NYSE:ZEN) closed Friday at $39.125, up $0.625. *