Roche reports progress in Accutane warning program - Hoffmann-La Roche Inc

FDA Consumer, Sept, 1991

Oclassen Pharmaceuticals, Inc., San Rafael, Calif, manufacturer of Condylox, and Burroughs Wellcome Co., Research Triangle Park, N.C., will co-market the drug.

Leukemia Drug Available Under Treatment IND

Certain patients with an acute form of leukemia may now undergo treatment with a new bone marrow purging agent approved by FDA for wider experimental use.

FDA authorized the expanded use of Pergamid (4-hydroperoxycylophosphamide, or 4-HC) June 14 under the agency's treatment IND (investigational new drug) program. The program allows desperately ill patients to receive promising but investigational therapies that FDA has not yet approved for marketing.

In this treatment, doctors remove a portion of the patient's bone marrow and treat it with Pergamid to kill cancer cells. Pergamid kills the malignant cells in the bone marrow without destroying the marrow's capacity to grow new blood cells. The patient is given high doses of chemotherapy and radiation to kill cancer cells in the body. Doctors then reinfuse the Pergamid-treated bone marrow into the patient.

The treatment is intended for patients with acute myelogenous leukemia - a rapidly progressive form of leukemia - who have had two or more remissions with conventional drug therapy and now need autologous (self-donated) bone marrow transplants. Studies show that these patients may have a better chance of survival than similar patients who are treated with conventional therapy without bone marrow transplants.

FDA has granted orphan status to Pergamid because acute myelogenous leukemia afflicts fewer than 200,000 people in the United States. FDA's "orphan" program encourages the development of drugs to treat rare disorders by providing financial incentives to drug manufacturers.

FDA has granted the treatment IND protocol to Nova Pharmaceutical Corp. of Baltimore, Md. Generic Conjugated Estrogens off Market

Previously approved generic versions of conjugated estrogen tablets may no longer be sold because they haven't been shown to be equivalent to the original drug, Premarin Tablets. FDA withdrew marketing approval of the generics, used to treat estrogen deficiency and osteoporosis, as of April 24 and May 6.

New evidence indicates the generic versions don't produce the same blood levels of estrogen as Premarin, made by Wyeth Ayerst Laboratories. After evaluating this and other information, relating dose to safety and effectiveness, the agency concluded the generics are neither safe nor effective for their intended uses.

Division to Approve Cancer Drugs

Officials in FDA's division of oncology and pulmonary drug products now have direct authority to approve new cancer drugs. This is the first time one of FDA's drug divisions has been given authority to take actions on its own for a major class of drugs. On May 29, Robert Temple, M.D., director of the Office of New Drug Evaluation 1, delegated the approval authority to simplify the drug approval process for new cancer drugs and to get the drugs to patients more quickly.