Ipilimumab Contributions by green crane

Ipilimumab received a Black Box Warning related to the risk of severe immune reactions that can cause inflammation and severe complications of liver, skin, nervous, intestines, hormone glands and eyes.

Black Box Warnings are given for prescription drugs that may cause severe adverse effects. It is intended to help doctors and patients discuss the risks.

The risks of ipilimumab are well documented, and consistent with cancer immunotherapy and auto immune reactions. The severity of metastatic melanoma often warrants risks where a less fatal disease would not.

Ipilimumab received a Black Box Warning related to the risk of severe immune reactions that can cause inflammation and severe complications of liver, skin, nervous, intestines, hormone glands and eyes.

Black Box Warnings are given for prescription drugs that may cause severe adverse effects. It is intended to help doctors and patients discuss the risks.

The risks of ipilimumab are well documented, and consistent with cancer immunotherapy and auto immune reactions. The severity of metastatic melanoma often warrants risks where a less fatal disease would not.

Ipilimumab, the first cancer immunotherapy for metastatic melanoma, is the first drug to be FDA approved in many years. Ipilimumab is sold as Yervoy by Bristol-Meyers Squibb. Interleukin-2, the last drug to have been approved for treating melanoma was approved in 1998 and only benefits 10-15% of patients with advanced disease. Dacarbazine, a chemotherapy approved in 1975, shows similar efficacy.

Zelboraf – the targeted cancer therapy vemurafenib – benefits ~80% of the patients who test positive for the B-raf mutation. Vemurafenib was also FDA approved in 2011 for metastatic melanoma. There are ongoing tests for the combination of vemurafenib (Zelboraf) and ipilimumab (Yervoy) with optimism for finding a very effective treatment for melanoma.

Cancer immunotherapy works by promoting the normal body immune system attempts to kill foreign cells, but not the body’s own cells. Tumor cells are the body’s own cells, but the changes that lead to excessive growth make the cells slightly different. If that difference were identified, then the body’s immune system could kill those tumor cells. Normally CTLA-4 blocks the immune response and protects the body’s regular cells. Ipilimumab binds to the receptors on immune cells in place of the CTLA-4 and dials down the prevention of immune cells from killing the regular cells. The goal is for the immune system to now kill the tumor cells preferentially over the regular cells, which was observed for 20-30% of the patients. There is a difficult balance where the more powerful immune system does attack the body’s regular cells as well and leads to auto-immune disorder side effects like rashes and trouble with digestion.

1. "Ipilimumab." U S Food and Drug Administration Home Page. 25 Mar. 2011. Web. 02 Nov. 2011. <http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm248478.htm>.
2. Peggs, KS, SA Quezada, AJ Korman, and JP Allison. "Principles and Use of Anti-CTLA4 Antibody in Human Cancer Immunotherapy." Current Opinion in Immunology(2006): 206-13. Http://www.ncbi.nlm.nih.gov. Pub Med, 18 Apr. 2006. Web. 04 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/16464564?dopt=Citation>.
3. Wolchok, Jedd D., Jeffrey S. Weber, and Omid Hamid. "Ipilimumab Efficacy and Safety in Patients with Advanced Melanoma: a Retrospective Analysis of HLA Subtype from Four Trials." Cancer Immunology (2010). Print.
4. Robert, C., L. Thomas, and I. Bondarenko. "Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma." New England Journal of Medicine 364.26 (2011): 2517-526. Print.
5. "Dacarbazine, DTIC Dome, DIC - Chemotherapy Drugs, Chemo Drug Side Effects."Chemotherapy Drugs and Side Effects Information - Chemo Care. Web. 02 Nov. 2011. <http://www.chemocare.com/bio/dacarbazine.asp>.
6. Jelic, S., N. Babovic, and V. Kovcin. "Comparison of the Efficacy of Two Different Dosage Dacarbazine-based Regimens and Two Regimens without Dacarbazine in Metastatic Melanoma: a Single-centre Randomized Four-arm Study." Melanoma Results. Pub Med, 12 Feb. 2002. Web. 02 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/11828263>.
7. Brockey, Mike. "I Am Now on Vemurafenib and Feeling Pretty Good." SMelanoma, Cancer Stinks! Blogger.com, 22 Aug. 2011. Web. 02 Nov. 2011. <http://www.smelanoma.com/2011/08/i-am-now-on-vemurafenib-and-feeling.html>.
8. "Melanoma (stage III or IV) - Ipilimumab: Appraisal Consultation Document." Http://guidance.nice.org.uk. National Institute for Clinical Excellence, 14 Oct. 2011. Web. 04 Nov. 2011. <http://guidance.nice.org.uk/TA/WaveCRS2/48/Consultation/DraftGuidance>.
9. "Yervoy (patient Information)." Www.yervoy.com. Bristol-Meyers Squibb. Web. 2 Nov. 2011. <http://www.yervoy.com/patient.aspx>

Enter section content...

Ipilimumab, the first cancer immunotherapy for metastatic melanoma, is the first drug to be FDA approved in many years. Ipilimumab is sold as Yervoy by Bristol-Meyers Squibb. Interleukin-2, the last drug to have been approved for treating melanoma was approved in 1998 and only benefits 10-15% of patients with advanced disease. Dacarbazine, a chemotherapy approved in 1975, shows similar efficacy.

Zelboraf – the targeted cancer therapy vemurafenib – benefits ~80% of the patients who test positive for the B-raf mutation. Vemurafenib was also FDA approved in 2011 for metastatic melanoma. There are ongoing tests for the combination of vemurafenib (Zelboraf) and ipilimumab (Yervoy) with optimism for finding a very effective treatment for melanoma.

Cancer immunotherapy works by promoting the normal body immune system attempts to kill foreign cells, but not the body’s own cells. Tumor cells are the body’s own cells, but the changes that lead to excessive growth make the cells slightly different. If that difference were identified, then the body’s immune system could kill those tumor cells. Normally CTLA-4 blocks the immune response and protects the body’s regular cells. Ipilimumab binds to the receptors on immune cells in place of the CTLA-4 and dials down the prevention of immune cells from killing the regular cells. The goal is for the immune system to now kill the tumor cells preferentially over the regular cells, which was observed for 20-30% of the patients. There is a difficult balance where the more powerful immune system does attack the body’s regular cells as well and leads to auto-immune disorder side effects like rashes and trouble with digestion.

Ipilimumab, the first cancer immunotherapy for metastatic melanoma, is the first drug to be FDA approved in many years. Ipilimumab is sold as Yervoy by Bristol-Meyers Squibb. Interleukin-2, the last drug to have been approved for treating melanoma was approved in 1998 and only benefits 10-15% of patients with advanced disease. Dacarbazine, a chemotherapy approved in 1975, shows similar efficacy.

Zelboraf – the targeted cancer therapy vemurafenib – benefits ~80% of the patients who test positive for the B-raf mutation. Vemurafenib was also FDA approved in 2011 for metastatic melanoma. There are ongoing tests for the combination of vemurafenib (Zelboraf) and ipilimumab (Yervoy) with optimism for finding a very effective treatment for melanoma.

Cancer immunotherapy works by promoting the normal body immune system attempts to kill foreign cells, but not the body’s own cells. Tumor cells are the body’s own cells, but the changes that lead to excessive growth make the cells slightly different. If that difference were identified, then the body’s immune system could kill those tumor cells. Normally CTLA-4 blocks the immune response and protects the body’s regular cells. Ipilimumab binds to the receptors on immune cells in place of the CTLA-4 and dials down the prevention of immune cells from killing the regular cells. The goal is for the immune system to now kill the tumor cells preferentially over the regular cells, which was observed for 20-30% of the patients. There is a difficult balance where the more powerful immune system does attack the body’s regular cells as well and leads to auto-immune disorder side effects like rashes and trouble with digestion.

The normal body immune system attempts to kill foreign cells, but not the body’s own cells. Tumor cells are the body’s own cells, but the changes that lead to excessive growth make the cells slightly different. If that difference were identified, then the body’s immune system could kill those tumor cells. Normally CTLA-4 blocks the immune response and protects the body’s regular cells. Ipilimumab binds to the receptors on immune cells in place of the CTLA-4 and dials down the prevention of immune cells from killing the regular cells. The goal is for the immune system to now kill the tumor cells preferentially over the regular cells, which was observed for 20-30% of the patients. There is a difficult balance where the more powerful immune system does attack the body’s regular cells as well and leads to auto-immune disorder side effects like rashes and trouble with digestion. This is the main challenge of cancer immunotherapy. While Ipilimumab was tested and approved for metastatic melanoma, there are ongoing studies for lung, ovarian, and prostate cancer where it is suspected that the immune system would preferentially attack those cancerous cells too.

Ipilimumab (sold as Yervoy) was approved for metastatic melanoma treatment by the FDA March 2011¹ and is a promising example of cancer immunotherapy. The drug is classified as a biotherapy, not a chemotherapy. Where chemotherapy kills dividing cells and biotherapy bolsters the body’s immune system to fight the disease. Ipilimumab was developed from research by Dr. James Allison in the 1990s² to increase the body’s immune fight against cancer tumors by interfering with a mechanism tumors used to evade natural attack. By blocking the signals limiting immune response, the body is enabled to attack the tumors. The results of the Phase III trials showed that median overall survival was 10 months for patients treated using Yervoy, compared with six months for treatment using standard chemotherapy. Combined chemotherapy and Yervoy cancer immunotherapy showed average survival of 10 months. While the results are promising, they only benefitted 20-30% of the patients, and there were significant side effects. The best result was that 4 out of 403 lived 52-56 months.

Ipilimumab (sold as Yervoy) has side effects that come from the activation of T-cells and the body’s immune responses. The most common are side effects are very much like auto-immune disorders and include a number of adverse reactions including diarrhea, rash, fatigue, nausea, vomiting, decreased appetite, and abdominal pain. In the clinical trials, Ipilimumab use was stopped in 10% of the patients due to the severity of the side effects. Ipilimumab side effects varied widely with the test population, and can appear after the drug use is stopped. Sensitive patients were given hydrocortisone to reduce the immune system activity.^1,3,4,7,9

1. "Ipilimumab." U S Food and Drug Administration Home Page. 25 Mar. 2011. Web. 02 Nov. 2011. <http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm248478.htm>.
2. Peggs, KS, SA Quezada, AJ Korman, and JP Allison. "Principles and Use of Anti-CTLA4 Antibody in Human Cancer Immunotherapy." Current Opinion in Immunology(2006): 206-13. Http://www.ncbi.nlm.nih.gov. Pub Med, 18 Apr. 2006. Web. 04 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/16464564?dopt=Citation>.
3. Wolchok, Jedd D., Jeffrey S. Weber, and Omid Hamid. "Ipilimumab Efficacy and Safety in Patients with Advanced Melanoma: a Retrospective Analysis of HLA Subtype from Four Trials." Cancer Immunology (2010). Print.
4. Robert, C., L. Thomas, and I. Bondarenko. "Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma." New England Journal of Medicine 364.26 (2011): 2517-526. Print.
5. "Dacarbazine, DTIC Dome, DIC - Chemotherapy Drugs, Chemo Drug Side Effects."Chemotherapy Drugs and Side Effects Information - Chemo Care. Web. 02 Nov. 2011. <http://www.chemocare.com/bio/dacarbazine.asp>.
6. Jelic, S., N. Babovic, and V. Kovcin. "Comparison of the Efficacy of Two Different Dosage Dacarbazine-based Regimens and Two Regimens without Dacarbazine in Metastatic Melanoma: a Single-centre Randomized Four-arm Study." Melanoma Results. Pub Med, 12 Feb. 2002. Web. 02 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/11828263>.
7. Brockey, Mike. "I Am Now on Vemurafenib and Feeling Pretty Good." SMelanoma, Cancer Stinks! Blogger.com, 22 Aug. 2011. Web. 02 Nov. 2011. <http://www.smelanoma.com/2011/08/i-am-now-on-vemurafenib-and-feeling.html>.
8. "Melanoma (stage III or IV) - Ipilimumab: Appraisal Consultation Document." Http://guidance.nice.org.uk. National Institute for Clinical Excellence, 14 Oct. 2011. Web. 04 Nov. 2011. <http://guidance.nice.org.uk/TA/WaveCRS2/48/Consultation/DraftGuidance>.
9. "Yervoy (patient Information)." Www.yervoy.com. Bristol-Meyers Squibb. Web. 2 Nov. 2011. <http://www.yervoy.com/patient.aspx>

Ipilimumab (Yervoy) is given through an IV during an office visit every three weeks for a total of four doses. The recommended does is 3 mg/kg.⁹ The standard course of treatment costs about $120,000. For patients who showed severe side effects, the recommendation is to cease, use hydrocortisone, and to not try it again. Ipilimumab was approved by the FDA in March 2011, however, the UK National Institute of Clinical Excellence⁸ did not approve payment for the drug with the reasoning that it helped only 20-30% of the patients live approximately four months longer and the cost of the drug exceeded the perceived benefit. It will be important to follow the research as the drug is tried on other cancers and given to a larger number of patients in the US and other countries.

Ipilimumab (Yervoy) is given through an IV during an office visit every three weeks for a total of four doses. The recommended does is 3 mg/kg. The standard course of treatment costs about $120,000. For patients who showed severe side effects, the recommendation is to not try it again. Ipilimumab was approved by the FDA in March 2011, however, the UK National Institute for Clinical excellence did not approve payment for the drug with the reasoning that it helped only 20-30% of the patients live approximately four months longer and the cost of the drug exceeded the perceived benefit.⁸ It will be important to follow the research as the drug is tried on other cancers and given to a larger number of patients in the US and other countries.Ipilimumab received a Black Box Warning related to the risk of severe immune reactions that can cause inflammation and severe complications of liver, skin, nervous, intestines, hormone glands and eyes.

Black Box Warnings are given for prescription drugs that may cause severe adverse effects. It is intended to help doctors and patients discuss the risks.

The risks of ipilimumab are well documented, and consistent with cancer immunotherapy and auto immune reactions. The severity of metastatic melanoma often warrants risks where a less fatal disease would not.

Ipilimumab received a Black Box Warning related to the risk of severe immune reactions that can cause inflammation and severe complications of liver, skin, nervous, intestines, hormone glands and eyes.

Black Box Warnings are given for prescription drugs that may cause severe adverse effects. It is intended to help doctors and patients discuss the risks.

The risks of ipilimumab are well documented, and consistent with cancer immunotherapy and auto immune reactions. The severity of metastatic melanoma often warrants risks where a less fatal disease would not.

1. "Ipilimumab." U S Food and Drug Administration Home Page. 25 Mar. 2011. Web. 02 Nov. 2011. <http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm248478.htm>.
2. Peggs, KS, SA Quezada, AJ Korman, and JP Allison. "Principles and Use of Anti-CTLA4 Antibody in Human Cancer Immunotherapy." Current Opinion in Immunology(2006): 206-13. Http://www.ncbi.nlm.nih.gov. Pub Med, 18 Apr. 2006. Web. 04 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/16464564?dopt=Citation>.
3. Wolchok, Jedd D., Jeffrey S. Weber, and Omid Hamid. "Ipilimumab Efficacy and Safety in Patients with Advanced Melanoma: a Retrospective Analysis of HLA Subtype from Four Trials." Cancer Immunology (2010). Print.
4. Robert, C., L. Thomas, and I. Bondarenko. "Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma." New England Journal of Medicine 364.26 (2011): 2517-526. Print.
5. "Dacarbazine, DTIC Dome, DIC - Chemotherapy Drugs, Chemo Drug Side Effects."Chemotherapy Drugs and Side Effects Information - Chemo Care. Web. 02 Nov. 2011. <http://www.chemocare.com/bio/dacarbazine.asp>.
6. Jelic, S., N. Babovic, and V. Kovcin. "Comparison of the Efficacy of Two Different Dosage Dacarbazine-based Regimens and Two Regimens without Dacarbazine in Metastatic Melanoma: a Single-centre Randomized Four-arm Study." Melanoma Results. Pub Med, 12 Feb. 2002. Web. 02 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/11828263>.
7. Brockey, Mike. "I Am Now on Vemurafenib and Feeling Pretty Good." SMelanoma, Cancer Stinks! Blogger.com, 22 Aug. 2011. Web. 02 Nov. 2011. <http://www.smelanoma.com/2011/08/i-am-now-on-vemurafenib-and-feeling.html>.
8. "Melanoma (stage III or IV) - Ipilimumab: Appraisal Consultation Document." Http://guidance.nice.org.uk. National Institute for Clinical Excellence, 14 Oct. 2011. Web. 04 Nov. 2011. <http://guidance.nice.org.uk/TA/WaveCRS2/48/Consultation/DraftGuidance>.
9. "Yervoy (patient Information)." Www.yervoy.com. Bristol-Meyers Squibb. Web. 2 Nov. 2011. <http://www.yervoy.com/patient.aspx>

1. "Ipilimumab." U S Food and Drug Administration Home Page. 25 Mar. 2011. Web. 02 Nov. 2011. <http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm248478.htm>.
2. Peggs, KS, SA Quezada, AJ Korman, and JP Allison. "Principles and Use of Anti-CTLA4 Antibody in Human Cancer Immunotherapy." Current Opinion in Immunology(2006): 206-13. Http://www.ncbi.nlm.nih.gov. Pub Med, 18 Apr. 2006. Web. 04 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/16464564?dopt=Citation>.
3. Wolchok, Jedd D., Jeffrey S. Weber, and Omid Hamid. "Ipilimumab Efficacy and Safety in Patients with Advanced Melanoma: a Retrospective Analysis of HLA Subtype from Four Trials." Cancer Immunology (2010). Print.
4. Robert, C., L. Thomas, and I. Bondarenko. "Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma." New England Journal of Medicine 364.26 (2011): 2517-526. Print.
5. "Dacarbazine, DTIC Dome, DIC - Chemotherapy Drugs, Chemo Drug Side Effects."Chemotherapy Drugs and Side Effects Information - Chemo Care. Web. 02 Nov. 2011. <http://www.chemocare.com/bio/dacarbazine.asp>.
6. Jelic, S., N. Babovic, and V. Kovcin. "Comparison of the Efficacy of Two Different Dosage Dacarbazine-based Regimens and Two Regimens without Dacarbazine in Metastatic Melanoma: a Single-centre Randomized Four-arm Study." Melanoma Results. Pub Med, 12 Feb. 2002. Web. 02 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/11828263>.
7. Brockey, Mike. "I Am Now on Vemurafenib and Feeling Pretty Good." SMelanoma, Cancer Stinks! Blogger.com, 22 Aug. 2011. Web. 02 Nov. 2011. <http://www.smelanoma.com/2011/08/i-am-now-on-vemurafenib-and-feeling.html>.
8. "Melanoma (stage III or IV) - Ipilimumab: Appraisal Consultation Document." Http://guidance.nice.org.uk. National Institute for Clinical Excellence, 14 Oct. 2011. Web. 04 Nov. 2011. <http://guidance.nice.org.uk/TA/WaveCRS2/48/Consultation/DraftGuidance>.
9. "Yervoy (patient Information)." Www.yervoy.com. Bristol-Meyers Squibb. Web. 2 Nov. 2011. <http://www.yervoy.com/patient.aspx>

1. "Ipilimumab." U S Food and Drug Administration Home Page. 25 Mar. 2011. Web. 02 Nov. 2011. <http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm248478.htm>.
2. Peggs, KS, SA Quezada, AJ Korman, and JP Allison. "Principles and Use of Anti-CTLA4 Antibody in Human Cancer Immunotherapy." Current Opinion in Immunology(2006): 206-13. Http://www.ncbi.nlm.nih.gov. Pub Med, 18 Apr. 2006. Web. 04 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/16464564?dopt=Citation>.
3. Wolchok, Jedd D., Jeffrey S. Weber, and Omid Hamid. "Ipilimumab Efficacy and Safety in Patients with Advanced Melanoma: a Retrospective Analysis of HLA Subtype from Four Trials." Cancer Immunology (2010). Print.
4. Robert, C., L. Thomas, and I. Bondarenko. "Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma." New England Journal of Medicine 364.26 (2011): 2517-526. Print.
5. "Dacarbazine, DTIC Dome, DIC - Chemotherapy Drugs, Chemo Drug Side Effects."Chemotherapy Drugs and Side Effects Information - Chemo Care. Web. 02 Nov. 2011. <http://www.chemocare.com/bio/dacarbazine.asp>.
6. Jelic, S., N. Babovic, and V. Kovcin. "Comparison of the Efficacy of Two Different Dosage Dacarbazine-based Regimens and Two Regimens without Dacarbazine in Metastatic Melanoma: a Single-centre Randomized Four-arm Study." Melanoma Results. Pub Med, 12 Feb. 2002. Web. 02 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/11828263>.
7. Brockey, Mike. "I Am Now on Vemurafenib and Feeling Pretty Good." SMelanoma, Cancer Stinks! Blogger.com, 22 Aug. 2011. Web. 02 Nov. 2011. <http://www.smelanoma.com/2011/08/i-am-now-on-vemurafenib-and-feeling.html>.
8. "Melanoma (stage III or IV) - Ipilimumab: Appraisal Consultation Document." Http://guidance.nice.org.uk. National Institute for Clinical Excellence, 14 Oct. 2011. Web. 04 Nov. 2011. <http://guidance.nice.org.uk/TA/WaveCRS2/48/Consultation/DraftGuidance>.
9. "Yervoy (patient Information)." Www.yervoy.com. Bristol-Meyers Squibb. Web. 2 Nov. 2011. <http://www.yervoy.com/patient.aspx>

1. "Ipilimumab." U S Food and Drug Administration Home Page. 25 Mar. 2011. Web. 02 Nov. 2011. <http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm248478.htm>.
2. Peggs, KS, SA Quezada, AJ Korman, and JP Allison. "Principles and Use of Anti-CTLA4 Antibody in Human Cancer Immunotherapy." Current Opinion in Immunology(2006): 206-13. Http://www.ncbi.nlm.nih.gov. Pub Med, 18 Apr. 2006. Web. 04 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/16464564?dopt=Citation>.
3. Wolchok, Jedd D., Jeffrey S. Weber, and Omid Hamid. "Ipilimumab Efficacy and Safety in Patients with Advanced Melanoma: a Retrospective Analysis of HLA Subtype from Four Trials." Cancer Immunology (2010). Print.
4. Robert, C., L. Thomas, and I. Bondarenko. "Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma." New England Journal of Medicine 364.26 (2011): 2517-526. Print.
5. "Dacarbazine, DTIC Dome, DIC - Chemotherapy Drugs, Chemo Drug Side Effects."Chemotherapy Drugs and Side Effects Information - Chemo Care. Web. 02 Nov. 2011. <http://www.chemocare.com/bio/dacarbazine.asp>.
6. Jelic, S., N. Babovic, and V. Kovcin. "Comparison of the Efficacy of Two Different Dosage Dacarbazine-based Regimens and Two Regimens without Dacarbazine in Metastatic Melanoma: a Single-centre Randomized Four-arm Study." Melanoma Results. Pub Med, 12 Feb. 2002. Web. 02 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/11828263>.
7. Brockey, Mike. "I Am Now on Vemurafenib and Feeling Pretty Good." SMelanoma, Cancer Stinks! Blogger.com, 22 Aug. 2011. Web. 02 Nov. 2011. <http://www.smelanoma.com/2011/08/i-am-now-on-vemurafenib-and-feeling.html>.
8. "Melanoma (stage III or IV) - Ipilimumab: Appraisal Consultation Document." Http://guidance.nice.org.uk. National Institute for Clinical Excellence, 14 Oct. 2011. Web. 04 Nov. 2011. <http://guidance.nice.org.uk/TA/WaveCRS2/48/Consultation/DraftGuidance>.
9. "Yervoy (patient Information)." Www.yervoy.com. Bristol-Meyers Squibb. Web. 2 Nov. 2011. <http://www.yervoy.com/patient.aspx>

1. "Ipilimumab." U S Food and Drug Administration Home Page. 25 Mar. 2011. Web. 02 Nov. 2011. <http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm248478.htm>.
2. Peggs, KS, SA Quezada, AJ Korman, and JP Allison. "Principles and Use of Anti-CTLA4 Antibody in Human Cancer Immunotherapy." Current Opinion in Immunology(2006): 206-13. Http://www.ncbi.nlm.nih.gov. Pub Med, 18 Apr. 2006. Web. 04 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/16464564?dopt=Citation>.
3. Wolchok, Jedd D., Jeffrey S. Weber, and Omid Hamid. "Ipilimumab Efficacy and Safety in Patients with Advanced Melanoma: a Retrospective Analysis of HLA Subtype from Four Trials." Cancer Immunology (2010). Print.
4. Robert, C., L. Thomas, and I. Bondarenko. "Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma." New England Journal of Medicine 364.26 (2011): 2517-526. Print.
5. "Dacarbazine, DTIC Dome, DIC - Chemotherapy Drugs, Chemo Drug Side Effects."Chemotherapy Drugs and Side Effects Information - Chemo Care. Web. 02 Nov. 2011. <http://www.chemocare.com/bio/dacarbazine.asp>.
6. Jelic, S., N. Babovic, and V. Kovcin. "Comparison of the Efficacy of Two Different Dosage Dacarbazine-based Regimens and Two Regimens without Dacarbazine in Metastatic Melanoma: a Single-centre Randomized Four-arm Study." Melanoma Results. Pub Med, 12 Feb. 2002. Web. 02 Nov. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/11828263>.
7. Brockey, Mike. "I Am Now on Vemurafenib and Feeling Pretty Good." SMelanoma, Cancer Stinks! Blogger.com, 22 Aug. 2011. Web. 02 Nov. 2011. <http://www.smelanoma.com/2011/08/i-am-now-on-vemurafenib-and-feeling.html>.
8. "Melanoma (stage III or IV) - Ipilimumab: Appraisal Consultation Document." Http://guidance.nice.org.uk. National Institute for Clinical Excellence, 14 Oct. 2011. Web. 04 Nov. 2011. <http://guidance.nice.org.uk/TA/WaveCRS2/48/Consultation/DraftGuidance>.
9. "Yervoy (patient Information)." Www.yervoy.com. Bristol-Meyers Squibb. Web. 2 Nov. 2011. <http://www.yervoy.com/patient.aspx>

Ipilimumab (sold as Yervoy) was approved for metastatic melanoma treatment by the FDA March 2011¹ and is a promising example of cancer immunotherapy. The drug is classified as a biotherapy, not a chemotherapy. Where chemotherapy kills dividing cells and biotherapy bolsters the body’s immune system to fight the disease. Ipilimumab was developed from research by Dr. James Allison in the 1990s (get ref) ² to increase the body’s immune fight against cancer tumors by interfering with a mechanism tumors used to evade natural attack. By blocking the signals limiting immune response, the body is enabled to attack the tumors. The results of the Phase III trials showed that median overall survival was 10 months for patients treated using Yervoy, compared with six months for treatment using standard chemotherapy. Combined chemotherapy and Yervoy cancer immunotherapy showed average survival of 10 months. While the results are promising, they only benefitted 20-30% of the patients, and there were significant side effects. The best result was that 4 out of 403 lived 52-56 months.

The normal body immune system attempts to kill foreign cells, but not the body’s own cells. Tumor cells are the body’s own cells, but the changes that lead to excessive growth make the cells slightly different. If that difference were identified, then the body’s immune system could kill those tumor cells. Normally CTLA-4 blocks the immune response and protects the body’s regular cells. Ipilimumab binds to the receptors on immune cells in place of the CTLA-4 and dials down the prevention of immune cells from killing the regular cells. The goal is for the immune system to now kill the tumor cells preferentially over the regular cells, which was observed for 20-30% of the patients. There is a difficult balance where the more powerful immune system does attack the body’s regular cells as well and leads to auto-immune disorder side effects like rashes and trouble with digestion. This is the main challenge of cancer immunotherapy. While Ipilimumab was tested and approved for metastatic melanoma, there are ongoing studies for lung, ovarian, and prostate cancer where it is suspected that the immune system would preferentially attack those cancerous cells too.