ESA Class Label Changes and ODAC Meeting

The following information is provided by AMGEN, an ANCO Corporate Member.

Amgen and Ortho Biotech received updated safety information last week to their package inserts from the U.S. Food and Drug Administration (FDA), which includes updates to the BOXED WARNINGS and WARNINGS sections in the labeling information for the ESA class of drugs including Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa) and Procrit® (Epoetin alfa).

The updated BOXED WARNING states that ESAs, when administered to target a hemoglobin of ≥ 12 g/dL, shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.

Please note that the previous BOXED WARNING limited the breast cancer patients to patients with advanced breast cancer and did not include patients with cervical cancer.

In the WARNINGS: Increased Mortality and/or Tumor Progression section, the interim results of the PREPARE study in neo-adjuvant breast cancer as well as follow up data from the Gynecologic Oncology Group study in cervical cancer were added to the text and table.

Amgen is informing healthcare professionals about the revisions to the U.S. prescribing information through a joint “Dear Healthcare Professional” letter with Ortho Biotech and will post the letter and updated prescribing information on www.amgen.com and www.aranesp.com.

In addition to communicating the changes in the labeling, the DHCP letter also announces the efforts by both companies to ensure that HCPs are disclosing to their patients important benefit and risk information about the ESA class before the initiation of this treatment.


ODAC
FDA’s Oncologic Drugs Advisory Committee (ODAC) recently met to discuss the cumulative safety and the benefit/risk profile of ESAs in oncology. Amgen takes very seriously the safety signals seen in recently disclosed trials where ESAs were used outside of the labeled indication. If you are interested, the presentations made by Amgen and the FDA to the ODAC are posted on www.amgen.com in the section called ESAs in the News.