UPDATE 1-Amgen, FDA discussing anemia drug label changes

(Recasts; adds details, background, previous NEW YORK)

LOS ANGELES, Dec 6 (Reuters) - Amgen Inc (AMGN.O: Quote, Profile, Research) said on Thursday it is talking with U.S. regulators about updating safety warnings for anemia drugs, after data from two studies stoked concerns about their use by breast and cervical cancer patients.

Amgen also said it has been advised there will be an Oncologic Drugs Advisory Committee meeting in the first quarter of 2008 as part of the review of the entire class of oxygen-boosting erythropoiesis-stimulating agent (ESA) drugs.

Thousand Oaks, California-based Amgen last year reaped $6.6 billion in revenue from its anemia drugs Aranesp and Epogen.

The U.S. Food and Drug Administration in March slapped its strictest "black box" warning label on anemia drugs made by Amgen and Johnson & Johnson (JNJ.N: Quote, Profile, Research).

In November, the agency strengthened the safety warning to reflect concerns that the drugs elevate risk of death, heart attack, stroke and the progression of certain cancers.

Amgen said last week that preliminary follow-up results from the independent PREPARE breast cancer study showed that the group that received Aranesp with chemotherapy prior to surgery had numerically more deaths and reports of tumor growth than the control group.

At the time, Amgen cautioned that no conclusions should be drawn from the data until the final study report is completed.

Separately, Johnson & Johnson's Ortho Biotech earlier this week announced results from an updated analysis of data from a study in which a group of chemotherapy-treated patients with advanced cervical cancer used its anemia drug, Procrit, to maintain hemoglobin levels above 12 grams per deciliter of blood.