Editing Darbepoetin alfa (section)

==Safety advisories in anemic cancer patients==
Amgen sent a "dear stockholders" letter in January 2007, that highlighted results from a recent anemia of cancer trial, and warned doctors to consider use in that off-label indication with caution.<ref>{{Cite web|last=Amgen|date=2007|title=Amgen 2007 Annual Report and Financial Summary|url=https://investors.amgen.com/static-files/5a4e76cb-55c8-48ff-b1a1-f4098e7f6d74|access-date=24 January 2022|archive-date=24 January 2022|archive-url=https://web.archive.org/web/20220124122903/https://investors.amgen.com/static-files/5a4e76cb-55c8-48ff-b1a1-f4098e7f6d74|url-status=dead}}</ref>

Amgen advised the U.S. [[Food and Drug Administration]] (FDA) as to the results of the [[DAHANCA]] 10 clinical trial.  The DAHANCA 10 data monitoring committee found that 3-year loco-regional control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01).<ref>{{cite journal | vauthors = Wauters I, Pat K, Vansteenkiste J | title = Flexible dosing with Darbepoetin alfa for the treatment of chemotherapy-induced anemia | journal = Therapeutics and Clinical Risk Management | volume = 2 | issue = 2 | pages = 175–186 | date = June 2006 | doi = 10.2147/tcrm.2006.2.2.175 | doi-access = free | pmid = 18360591 | pmc = 1661657 }}</ref>

In response to these advisories, the FDA released a [[Public Health Advisory]]<ref>{{cite web|url=https://www.fda.gov/cder/drug/advisory/RHE2007.htm |title=FDA Public Health Advisory: Erythropoiesis-Stimulating Agents (ESAs): Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) |website=[[Food and Drug Administration]] |access-date=5 June 2007 |archive-url=https://web.archive.org/web/20070528103823/https://www.fda.gov/cder/drug/advisory/RHE2007.htm |archive-date=28 May 2007 |url-status=dead }}</ref>
on 9 March 2007, and a clinical alert<ref>{{cite web|url=https://www.fda.gov/cder/drug/InfoSheets/HCP/RHE2007HCP.htm |title=Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA) |website=[[Food and Drug Administration]] |access-date=5 June 2007 |archive-url=https://web.archive.org/web/20070515034509/https://www.fda.gov/cder/drug/InfoSheets/HCP/RHE2007HCP.htm |archive-date=15 May 2007 |url-status=dead }}</ref> for doctors on 16 February 2007, about the use of [[Erythropoiesis-stimulating agent|erythropoeisis-stimulating agents (ESAs)]] such as [[epoetin alfa]] (marketed as Epogen) and darbepoetin alfa.  The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings.

According to the 2010 update to clinical practice guidelines from the [[American Society of Clinical Oncology]] (ASCO) and the [[American Society of Hematology]] (ASH), use of ESAs such as darbepoetin alfa in cancer patients is appropriate when following stipulations outlined in FDA-approved labeling.<ref>{{cite journal | vauthors = Rizzo JD, Brouwers M, Hurley P, Seidenfeld J, Arcasoy MO, Spivak JL, Bennett CL, Bohlius J, Evanchuk D, Goode MJ, Jakubowski AA, Regan DH, Somerfield MR | title = American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer | journal = Journal of Clinical Oncology | volume = 28 | issue = 33 | pages = 4996–5010 | date = November 2010 | pmid = 20975064 | pmc = 2988667 | doi = 10.1200/jco.2010.29.2201 | url = http://www.asco.org/quality-guidelines/asco-ash-clinical-practice-guideline-update-use-epoetin-and-darbepoetin-adult | url-status = dead | archive-url = https://web.archive.org/web/20141103190540/http://www.asco.org/quality-guidelines/asco-ash-clinical-practice-guideline-update-use-epoetin-and-darbepoetin-adult | archive-date = 3 November 2014 }}</ref>