FDA Approves New Melanoma Treatment Yervoy
First Drug to Extend Survival in Late-Stage Skin Cancer
By Daniel J. DeNoon
WebMD Health News Reviewed by Laura J. Martin, MD
March 25, 2011 -- The FDA has approved Bristol-Myers' Yervoy for the treatment of late-stage, metastatic melanoma, a deadly skin cancer.
Yervoy (ipilimumab) is the first drug ever shown to help late-stage melanoma patients live longer. However, it does not cure the disease.
"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," Richard Pazdur, MD, director of the FDA's cancer drugs office, says in a news release.
In a clinical trial with 676 late-stage melanoma patients for whom all other treatments had failed -- and for whom surgery was not an option -- patients taking Yervoy survived an average of 10 months after starting treatment. Patients taking an experimental vaccine lived an average of 6.5 months.
Yervoy also appears to extend survival when used as a first-line treatment for inoperable stage III or stage IV melanoma, Bristol-Myers announced earlier this week. Details of the study will be reported at the June meeting of the American Society of Clinical Oncology.
Yervoy is a biologic therapy. It's a kind of man-made antibody (a monoclonal antibody) that blocks a crucial switch on immune cells called CTLA-4. Cancers use this switch to turn off the body's anticancer immune responses.
Most drugs like this come with possibly severe side effects, and Yervoy is no exception. The drug can provoke powerful autoimmune reactions in which the immune system attacks normal cells in the body. In clinical trials, nearly 13% of patients taking Yervoy had severe or fatal autoimmune reactions.
Common side effects resulting from such autoimmune reactions linked to Yervoy include fatigue, diarrhea, skin rash, hormone deficiencies, and colitis (inflammation of the intestines).
Because of these unusually severe side effects, Bristol-Myers has agreed to establish what the FDA calls a risk evaluation and mitigation strategy (REMS) to help doctors avoid and manage adverse reactions to Yervoy.
THanks for posting this, Jeff. I have passed it on to my BiL, we will see what happens...I hope all is well.
Good health, kermica
When the world says, "Give up," Hope whispers, "Try it one more time."
Follicular lymphoma diagnosed August 08, Stage 1
2 cycles (20 treatments each) localized radiation to tumor sites. Remission confirmed July 09
Restaged to Stage 3 May 2010
Recurrence confirmed May 2010 - Watch and Wait commenced - multiple scans with minimal progression.
Cutaneous Squamous Cell Carcinoma diagnosed September 2012. Mohs surgical excision 09/2012. Successful, clean edges all around.
Significant progression detected in PET scan - December 2012
Biopsy to check for transformation 1/18/2013 - negative for that but full of lymphoma, of course.
July 2013 - Rescan due to progression shows one tumor (among many) very suspect for transformation, another biopsy 8/12/13.
August 2013 - No evidence of transformation, 6 courses of B+R commence 8/29 due to "extensive, systemic disease".
February 2014 - Diagnostic PET scan states: Negative PET scan. Previous noted hypermetabolic cervical, axillary, iliac and inguinal lymphadenopathy has resolved. Doctor confirms full remission.
June 2014 - started 2 year maintenance Rituxin, 1 infusion every 3 months. Doctor confirms lump under right arm are "suspicious" for recurrent disease, deferring scans for now.
February 2015 - Doc and I agreed to stop R maintenance as it is depressing my immune system too much.
June 2015 - Confirm that the beast is back by physical exam, will scan in August after esophageal issues settle down so we can get a clear view.
August 2015 - physical exam in error, PET/CT shows no evidence of disease. Remission continues well into second year!