FDA Year-End Approvals Round-Up

The seasonal round-up of product approvals by the US Food and Drug Administration came as expected at the end of 1995, although in contrast to previous years these were spread more evenly throughout the month of December.

A number of new cancer treatments were approved, most notably Zeneca's new treatment for advanced breast cancer in post-menopausal women, Arimidex (anastrozole). Arimidex, first approved in the UK in September 1995, is the first in a new generation of selective aromatase inhibitors and is indicated for use in patients whose disease has progressed following tamoxifen therapy. Zeneca says it is pursuing a first-line indication via a comparative trial with tamoxifen, and is also committed to completing and submitting to the FDA results of two other ongoing studies, including one comparing Arimidex with Ciba's formestane.

Zeneca also gained an important approval for its fastest-growing product Zoladex (goserelin acetate). Already approved for advanced prostate cancer and endometriosis in the USA, the FDA cleared a third indication, advanced breast cancer in pre- and perimenopausal women, which should drive the growth of the product still further. The product is already approved for this latter indication in 72 countries worldwide. The drug is expected to be of particular value in younger women who do not wish to undergo oopherectomy and whose physicians dislike using tamoxifen in premenopausal patients.