FDA Approves Pfizer's Ellence

Ellence is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

The exact way it works is not fully understood.

Ellence is used to treat certain types of breast cancer following surgery. It may also be used to treat other cancers.

Ellence is used to treat cancers in the lymph system, lungs, breast, stomach and ovaries. It belongs to a group of medicines called antineoplastics, which are drugs that inhibit and fight the development of abnormal masses of tissue (neoplasms). It is also an anthracycline, which slows and stops the growth of cancer cells.

Ellence appears to interfere with cancer cell growth, though the growth of normal cells may also be affected by the drug.

Ellence (pronounced el-LENCE) (epirubicin hydrochloride injection), marketed by Pharamacia &Upjohn, is an anthracycline antineoplastic antibiotic marketed as Farmorubicin(r) outside the U.S. and is currently used in more than 80 countries to treat a variety of cancers, including metastatic breast cancer. Ellence has been recommended by the Oncologic Drugs Advisory Committee to the U.S. Food and Drug Administration for approval as a component of adjuvant therapy for patients with node tumor involvement following resection of primary breast cancer. Although recommended as an adjuvant therapy by the FDA Advisory Committee, Ellence (epirubicin) was NOT recommended as first-line therapy for patients with locally advanced or metastatic breast cancer. This is not the first time Pharmacia & Upjohn has submitted an NDA – New Drug Application – for Ellence for first-line therapy. In 1984, the FDA designated the submission “not approvable” due to an insufficient amount of data. This time around, the FDA Advisory Committee is calling into question overall survival data vs. time to progression in patients with locally advanced or metastatic breast cancer when the drug is used for firs-line therapy. Pharmacia & Upjohn plans to resubmit for this indication in the future.

ELLENCE Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.