ODAC Recommends Approval of Three Agents

 SILVER SPRING, Md—The Oncologic Drugs Advisory Committee (ODAC) recommended at its most recent meeting that the Food and Drug Administration approve one new anticancer agent and additional indications for two available agents. Complete reports on the panel’s three recommendations will appear in the next issue of Oncology News International.

The panel urged:

Marketing approval for Ellence (epirubicin hydrochloride for injection, Pharmacia & Upjohn) for use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer (stage II and III).

The panel, however, refused to recommend Ellence’s approval as a therapy for patients with locally advanced or metastatic breast cancer. Epirubicin, marketed elsewhere as Farmorubicin, was first approved in France in 1982 and is now registered in 80 countries.

Accelerated approval of a supplemental New Drug Application for Doxil (doxorubicin HCl liposome injection, Alza) for the treatment of patients with metastatic carcinoma of the ovary who are refractory to both paclitaxel (Taxol)- and platinum-based chemotherapy regimens. Refractory was defined as progressive disease while on treatment or within 6 months after completing therapy. Accelerated approval requires the company to conduct additional research to ensure that the drug is safe and effective.

Approval of a supplemental New Drug Application for Ethyol (amifostine for injection, US Bioscience) to decrease the incidence of moderate-to-severe xerostomia in patients undergoing postoperative radiation therapy for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.

(As Oncology News International went to press, the FDA granted approval for this new Ethyol indication. Ethyol is the first pharmaceutical product to receive approval to reduce the severity of radiation-induced toxicities in head and neck cancer patients.