erbitux

Avastin, Erbitux combo proves dangerous

Source: www.newsinferno.com
Author: staff

Combining Avastin and Erbitux with chemotherapy to treat colon cancer may actually make patients sicker, and cause their tumors to grow faster. According to a new Dutch study, using Avastin and Erbitux to increase the effectiveness of chemotherapy is a complete failure, and could actually cut the survival time of patients by as much as a month.

Avastin was approved by the Food & Drug Administration (FDA) in 2004 to treat colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. Last year, the FDA also approved Avastin as a breast cancer treatment. Avastin was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor.

Erbitux is indicated for the treatment of patients who have colorectal cancer that has spread to other parts of the body and whose tumor expresses a protein called an Epidermal Growth Factor Receptor. Erbitux was approved by the FDA to treat advanced colon cancer in 2004, and again in 2006 for treating squamous cell carcinoma of the head and neck

It was theorized that adding Erbitux and Avastin to chemotherapy could boost benefits, but unfortunately, the Dutch study has proven the opposite to be true. The study looked at 732 patients; 378 patients where treated with chemo plus Avastin. The remaining patients received chemo along with Avastin and Erbitux.

Median progression-free survival was 10.7 months among those receiving only Avastin with their chemo. That figure dropped to 9.4 months in patients treated with both Avastin and Erbitux. Likewise, median over-all survival in the Avastin plus chemo group was 20.3 months, but fell to 19.4 months in those who received both drugs with chemo.

The combo also appeared to have caused more adverse effects among patients, primarily skin conditions. Nearly twice as many patients given the Avastin – Erbitux company reported skin problems, with an acne-like rash being the most common.

This is not the first time an Avastin drug combo has disappointed. Last summer, trials involving the use of Avastin with Sutent – one of the most widely used medicines for the treatment of advanced kidney cancer – was stopped after patients developed a dangerous type of anemia.

Avastin has been linked to other safety worries. When the FDA approved Avastin for breast cancer patients last year, it did so against the recommendation of its own advisory panel. In late 2007, the panel voted 5-4 to recommend that the agency reject Genentech’s application to expand the approved uses of the drug to include advanced breast cancer.

The FDA advisory panel vote came after agency staffers posted documents on the FDA website noting that while Avastin did extend the period prior to patients’ breast cancer becoming worse, treatment with the drug did not markedly increase survival time. The FDA documents also pointed out that Avastin caused serious side effects, including cardiovascular problems, bowel perforations, and a few deaths. The FDA staff said that those side effects included several patient deaths that were “probably or definitely” due to Avastin.

Last June, researchers at Stony Brook University Cancer Center in New York released a study of an analysis of 15 clinical trials involving nearly 8,000 patients that indicate those taking Avastin were at a higher risk of blood clots. The Stony Brook study showed that about 12 percent of people who took Avastin developed blood clots in the veins, a rate that’s about 30 percent higher than among other cancer patients who are not taking it. These types of blood clots put patients at a higher risk of death, because they can travel to the lungs. Clots are already a common problem faced by cancer patients.

In December, Genentech also reported that some Avastin patients had experienced eye inflammation when it was used off-label to treat an eye condition.

February, 2009|Oral Cancer News|

Merck Serono launches Erbitux in 1st-line treatment of head and neck cancer in Europe

Source: www.medadnews.com
Author: press release

Today leading oncology specialists and media gathered at the Antwerp University Hospital to mark the European launch of Erbitux® (cetuximab) for the 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), following European Commission approval to extend the use of the targeted therapy. Erbitux was previously approved for use in combination with radiotherapy for locally advanced SCCHN.

The approval of Erbitux in this new indication was granted in November 2008 and based primarily upon the results of the EXTREMEa study, published in the New England Journal of Medicine in September 2008. The EXTREME study established that adding Erbitux to platinum-based chemotherapy significantly prolonged median overall and progression-free survival, and also significantly increased response rate.1

The principal investigator of the EXTREME trial, Professor Jan Vermorken from the Antwerp University Hospital, a world renowned center of excellence in oncology research and treatment said: “We are pleased to be hosting the international launch of Erbitux in this notoriously difficult to treat cancer type. This is the first treatment regimen in 30 years to show a survival benefit and denotes a significant milestone in the advancement of treatment for head and neck cancer.”

The EXTREME study demonstrated that patients treated with Erbitux plus chemotherapy experienced the following improvements, compared to chemotherapy alone:1
• Median overall survival increase of nearly 3 months (10.1 vs. 7.4 months; p=0.04), equating to a 20% reduction in the risk of death (HR: 0.80) during the study period
• 70% relative increase in median progression-free survival (5.6 vs. 3.3 months; p<0.001)
• Almost doubling of response rate (36% vs. 20%; p<0.001)

Concurrent with the launch of Erbitux, preliminary results were released from a new European survey “About Face”, which was conducted by the European Head and Neck Society (EHNS) to investigate the awareness of head and neck cancer among the general public. The results showed alarmingly low levels of knowledge about the symptoms, risk factors and body parts affected by the disease2 despite it being the sixth-most common cancer worldwide .3

In Europe alone, it is estimated that there are around 143,000 new cases of head and neck cancer and more than 68,000 deaths due to the disease each year.4 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN.5 Head and neck cancer includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinuses and other sites located in the head and neck area. About 90% of head and neck cancers are of the squamous cell variety6 and nearly all express the epidermal growth factor receptor (EGFR) which is critical for tumor growth.7 Erbitux targets the EGFR. Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease and often have second primary tumors in addition to suffering from other co-morbidities.8 At least 75% of all head and neck cancers are attributed to two major risk factors, smoking and alcohol consumption.9

“We are honored to launch Erbitux in the 1st-line treatment for recurrent and/or metastatic SCCHN at a facility renowned for its pioneering work into head and neck cancer,” said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. “We hope that patients and specialists alike are encouraged by this first significant advance in this treatment setting in 30 years. Today’s launch reinforces the impressive potential of Erbitux to extend patients’ lives and further confirms the high activity of Erbitux against difficult to treat cancers.”

a EXTREME: ErbituX in 1st-line Treatment of REcurrent or MEtastatic head and neck cancer

References:
1. Vermorken JB, et al. N Engl J Med 2008;359:1116-27.
2. About Face survey [TNS Healthcare 2008. ‘About Face’ Head and Neck Cancer Awareness – EU Omnibus Survey
3. Hunter KD, et al. Nat Rev Cancer 2005;Feb;5(2):127-35
4. GLOBOCAN 2002 (www-dep.iarc.fr), accessed November 2008.
5. Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
6. Vermorken J. Ann Oncol 2005;16(Suppl 2):ii258-ii264.
7. Grandis JR & Tweardy DJ. Cancer Res 1993;53(15):3579-84.
8. Forastiere A, et al. N Engl J Med 2001;345(26):1890-1900.
9. Hashibe M, et al. J Natl Inst 2007;99:777-89.

January, 2009|Oral Cancer News|

Eli Lilly buys majority of ImClone in tender offer

Source: money.cnn.com
Author: staff

Drug developer Eli Lilly & Co. said Friday it completed a tender offer worth about $6 billion for ImClone Systems Inc., marking Lilly’s biggest buyout in the biotechnology industry.

The company announced the $70-per-share tender offer in October. The bid topped two prior offers from Bristol-Myers Squibb Co., which is ImClone’s partner on the blockbuster drug Erbitux.

Indianapolis-based Eli Lilly bought about 85.4 million shares of New York-based ImClone, representing about 95 percent of the outstanding stock. The company plans to complete the buyout through a short-form merger on or about Nov. 24. in which all remaining shares of ImClone will be converted into the right to receive $70 per share in cash.

With the buyout, Indianapolis-based Eli Lilly adds the blockbuster colon and head and neck cancer drug Erbitux to its list of products. Eli Lilly, which sells a range of treatments from Byetta for diabetes to Cymbalta for depression, has been bulking up its biotechnology capabilities along with several other large pharmaceutical companies.

Eli Lilly already gets about a third of its annual revenue from biotechnology drugs, which are developed using living cells instead of chemical compounds. The company has already invested $1 billion into a biotech center in Indianapolis, while building a biotech facility in Ireland.

November, 2008|Oral Cancer News|

FDA accepts priority review for new indication of Erbitux – update

Source: www.rttnews.com
Author: staff

Imclone Systems Inc. and Bristol-Myers Squibb Co. announced that the supplemental biological license application seeking expanded approval of Erbitux for first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck has been accepted for priority review by the U.S. Food and Drug Administration. Priority review implies that the FDA will review the application in six months.

Erbitux is marketed by ImClone and Bristol-Myers Squibb in the U.S. and by German drug and chemical maker Merck KGaA outside the U.S. Bristol-Myers holds 61% of the North American sales rights to Erbitux, while Merck KGaA owns 90% of the drug’s international distribution rights. Under the existing agreement with Bristol-Myers, ImClone receives a distribution fee based on a flat rate of 39% of net sales of Erbitux in North America.

The companies had sought expanded approval for Erbitux based on data from the randomized Phase 3 EXTREME (ERBITUX in first-line Treatment of REcurrent or MEtastatic head and neck cancer) study1 investigating the efficacy of Erbitux in combination with platinum-based chemotherapy in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

According to the study, which was conducted by Merck KGaA, Erbitux, in combination with platinum-based chemotherapy, resulted in a statistically significant improvement in median overall survival time compared with chemotherapy alone.

If approved, metastatic squamous cell carcinoma will be the third U.S. indication for Erbitux in head and neck cancer. Erbitux was initially approved to treat locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy, and as a single agent for the treatment of patients with recurrent or metastatic of the head and neck for whom prior platinum-based therapy did not work.

According to the American Cancer Society, 87,290 Americans will be diagnosed with head and neck cancer in 2008 and over 13,090 Americans are estimated to die from this disease this year.

Erbitux, a targeted therapy, which attacks cancer cells without damaging the normal cells was approved by the FDA in February 2004, in combination with irinotecan in the treatment of patients with metastatic colorectal cancer who are resistant to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. Last year, Erbitux notched $1.3 billion in global sales.

Imclone is aggressively pursuing further market penetration of Erbitux in the U.S. and Europe through product label expansion in colorectal cancer and head and neck cancer as well as in non-small cell lung cancer. On July 16, Erbitux was approved in Japan to treat patients with advanced or metastatic colorectal cancer.

Erbitux faces competition from Genentech Inc’s Avastin and Amgen Inc.’s colon cancer drug Vectibix. Avastin is approved by the FDA for advanced colorectal cancer, advanced non-squamous, non-small cell lung cancer and metastatic HER2-negative breast cancer. Ongoing Phase 3 trials are exploring the potential of administering Vectibix in combination with chemotherapy for first- and second-line metastatic colorectal cancer, as well as in the head and neck cancer setting.

November, 2008|Oral Cancer News|

Merck Serono’s Erbitux nominated for International Prix Galien Award – transforming head and neck cancer treatment

Source: www.medicalnewstoday.com
Author: staff

Merck Serono’s Erbitux® is one of the finalists for the prestigious International Prix Galien Award for excellence in pharmaceutical development and innovation due to its role in transforming the treatment of head and neck cancer.

Erbitux is the first and only targeted therapy approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN) and works in a completely different way to conventional chemotherapies. Through its targeted mode of action, Erbitux blocks the epidermal growth factor receptor (EGFR), which is expressed in more than 90% of SCCHN tumors1 and is directly related to a poor prognosis for patients. The efficacy and tolerability of this novel drug have been shown in clinical trials2 – the latest of which, EXTREMEa, demonstrated the first significant advance in 30 years for the treatment of recurrent and/or metastatic SCCHN. 3

“We are very pleased that Erbitux has been short-listed for arguably the most prestigious award in our industry,” said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. “This recognizes not only the outstanding clinical excellence of Erbitux but also the significant breakthrough that the drug offers patients with head and neck cancer, which is so difficult to treat. Merck Serono is passionate about advancing research across a range of oncology indications and improving the treatments available to cancer patients.”

Erbitux is licensed in locally-advanced SCCHN on the basis of data demonstrating that in combination with radiotherapy it achieved locoregional control for more than two years, almost 20 months more than with radiotherapy alone and without increasing the common side effects often observed following such treatment.2 Five-year survival data from the same trial recently presented at the 50th American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting in Boston showed that nearly half of the patients receiving Erbitux were alive at five years and Erbitux provides a diminution of 27% of the risk of death and an absolute survival benefit of 10% at five years compared to radiotherapy alone. 4

Erbitux is also demonstrating promise in the treatment of 1st line recurrent and/or metastatic SCCHN. New data from the pivotal EXTREME trial, recently published in the New England Journal of Medicine, demonstrated that when used in combination with traditional chemotherapy, Erbitux provides significant increases in overall survival, median progression-free survival and tumor response rate in the 1st-line treatment setting. 3 These results from the EXTREME trial have been used to support an EMEA application to broaden the use of Erbitux to include 1st-line treatment of recurrent and/or metastatic SCCHN, submitted in June 2008.

Erbitux was announced as the winner of the French Prix Galien Award in 2007 and was then submitted to the International Award competition in June 2008. Winners of the 10th International Prix Galien award will be announced in Berlin on October 30, 2008.

About the Prix Galien Award
The Prix Galien Award was established in France in 1970 to recognize outstanding achievement and innovation in medical research and development. Winners of National Prix Galien Awards can then enter the International Prix Galien Awards which take place every two years.

Head and Neck Cancer
Head and neck cancer includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. It is the sixth most frequently occurring cancer worldwide and, in Europe alone, it is estimated that there are around 143,000 cases of head and neck cancer, and more than 68,000 deaths due to the disease each year. 5 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN. 6 About 90% of head and neck cancers are of the squamous cell variety7 and nearly all express EGFR. 8 Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease and often have secondary tumors, in addition to suffering from other co-morbidities. 9 At least 75% of all head and neck cancers are attributed to its two major risk factors, smoking tobacco and alcohol consumption. 10

References
1. 1 – Vo-Nguyen TT & Ondrey F. Otolaryngol Head Neck Surg 2004;131(2):P177.
2. 2 – Bonner J, et al. N Eng J Med 2006;354:567-78.
3. 3 – Vermorken JB, et al. N Eng J Med 2008;359:1116-27.
4. 4 – Bonner J, et al. Late-breaking clinical trial update at ASTRO Congress 2008, Boston, MA, USA, 22 September.
5. 5 – GLOBOCAN 2002 (www-dep.iarc.fr). Last accessed August 2008.
6. 6 – Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
7. – 7Hunter KD, et al. Nat Rev Cancer 2005;5(2):127-35.
8. 8 – Grandis JR, Tweardy DJ. Cancer Res 1993;53(15):3579-84.
9. 9 – Forastiere A, et al. N Engl J Med 2001;345(26):1890-900.
10. 10 – Hashibe M, et al. J Natl Cancer Inst 2007;99:777-89.

For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.

About Erbitux
Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in 75 countries. It has been approved for the treatment of colorectal cancer in 74 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Japan, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, the US, and Venezuela for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. In the European Union, the license was updated in July 2008 for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC (metastatic colorectal cancer) in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Apart from the European Union label, Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, Japan, Lebanon, Liechtenstein, Mexico, Moldova, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela.

In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 69 countries: Argentina, Australia, Belarus, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Moldova, Nicaragua, Peru, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.

Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, ImClone Systems Incorporated, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.

October, 2008|Oral Cancer News|

Erbitux – first treatment in 30 years to prolong survival in 1st-line recurrent and/or metastatic head and neck cancer

Source: www.medicalnewstoday.com
Author: staff

Data presented at the 33rd European Society for Medical Oncology (ESMO) Congress in Stockholm demonstrate that the addition of Erbitux® (cetuximab) to platinum-based chemotherapy increases overall survival (OS) compared to chemotherapy alone in the 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).1 Furthermore the data showed the significant benefits of Erbitux were achieved without any detrimental impact on quality of life (QoL).2

“These data are incredibly exciting as they represent the first advance in the 1st-line treatment of head and neck cancer in this setting for three decades. For the first time since the introduction of platinum-based chemotherapy we are able to increase the overall survival time for recurrent and/or metastatic head and neck cancer patients,” said Professor Jan B. Vermorken, lead investigator of the EXTREMEa trial and head of the Department of Medical Oncology, Antwerp University Hospital, Belgium.

The EXTREME study was a multicenter, randomized, controlled, Phase III trial involving 442 patients, designed to assess the efficacy of Erbitux combined with cisplatin or carboplatin plus 5-fluorouracil (5-FU) versus chemotherapy alone in the 1st-line treatment of patients with recurrent and/or metastatic SCCHN.1

Patients treated with Erbitux plus chemotherapy experienced the following improvements, compared to chemotherapy alone:1

– Increased median overall survival of nearly 3 months (10.1 vs. 7.4 months; p=0.04), equating to a 20% risk reduction of death (HR: 0.80) during the study period

– A 70% increase in median progression-free survival (5.6 vs. 3.3 months; p<0.001)

– An 80% relative increase in response rate (36% vs. 20%; p<0.001)

The EXTREME trial also assessed the impact of treatment on quality of life (QoL) using two assessment questionnaires (QLQ-C30 and QLQ-H&N35) developed by the European Organization for Research and Treatment of Cancer (EORTC).2 QLQ-C30 is designed to assess QoL in cancer patients in general, whilst QLQ-H&N35 focuses specifically on head and neck cancer.3 Analysis of the completed questionnaires showed that the addition of Erbitux to chemotherapy delivered in most cases significant and clinically relevant benefits without impacting tolerability. Moreover, the QLQ-H&N35 results showed that patients receiving Erbitux saw significant improvement in areas such as pain and swallowing.2

“It is very encouraging to see that the positive impact Erbitux has on survival in patients with SCCHN is not accompanied by any additional, detrimental effects on quality of life. Indeed, the life quality benefits that our patients experience due to the tumor shrinkage induced by Erbitux therapy can make a real difference,” said Professor Vermorken.

The EXTREME study forms the basis of an application to the European Medicines Agency (EMEA), submitted in June of this year, to broaden the use of Erbitux from its current indication in locally advanced SCCHN to include the 1st-line treatment of patients with recurrent and/or metastatic disease.

Also presented at ESMO was a retrospective analysis of the EXTREME study which investigated the influence of epidermal growth factor receptor (EGFR) expression and gene copy number status on overall survival. No association was found between either EGFR expression or gene copy number status and overall survival in Erbitux-treated patients.1 Currently, there is no evidence to suggest that these predictive biomarkers play a clinically relevant role in the treatment of recurrent and/or metastatic SCCHN.4

Furthermore, the KRAS biomarker, found to be an important predictor of treatment efficacy in metastatic colorectal cancer, is not of importance in SCCHN, where nearly 95% of tumors are KRAS wild-type.5

Head and neck cancer

In Europe, it is estimated that there are around 140,000 cases of head and neck cancer, and more than 65,000 deaths due to the disease each year.6 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN. Head and neck cancer is the sixth most frequently occurring cancer worldwide6,7 and includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. About 90% of head and neck cancers are of the squamous cell variety8 and nearly all express EGFR, which is critical for tumor growth.9 Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease and often have secondary tumors, in addition to suffering from other co-morbidities.10 At least 75% of all head and neck cancers are attributed to its two major risk factors, smoking tobacco and alcohol consumption.11

a EXTREME: ErbituX in 1st-line Treatment of REcurrent or MEtastatic head and neck cancer

References
1. Vermorken JB, et al, ESMO 2008; Abstract No: 6870.
2. Rivera Herrero F, et al. ESMO 2008; Abstract No: 693.
3. http://groups.eortc.be/qol/index.htm.
4. Argiris A, et al. Lancet 2008;371:1695-1709.
5. Weber A, et al. Oncogene 2003;22:4757-59.
6. GLOBOCAN 2002 (http://www-dep.iarc.fr, accessed August 2008).
7. Vermorken JB, et al. J Clin Oncol 2007;25(18S).
8. Hunter KD, et al. Nat Rev Cancer 2005; (2):127-35.
9. Bourhis J, and Pinto H. Redefining ‘State of the Art’ in Head and Neck Cancer. Oral presentation, 6th International Conference on Head and Neck Cancer 7-11 August 2004.
10. Forastiere A, et al. N Engl J Med 2001;345(26):1890-900.
11. Hashibe M, et al. J Natl Inst 2007;99:777-89.

For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: http://www.globalcancernews.com.

About Erbitux
Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 68 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldavia, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Moldavia, Nicaragua, Peru, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.

September, 2008|Oral Cancer News|

Erbitux aims for first-line head, neck cancer use

Source: www.reuters.com
Author: Ransdell Pierson

ImClone Systems Inc. on Wednesday said it had asked U.S. regulators for permission to market its Erbitux medicine as a first-line treatment for head and neck cancer.

The company’s flagship product, which it sells in partnership with Bristol-Myers Squibb Corp, is already approved to treat colorectal cancer and patients with head and neck cancer who previously had failed to benefit from chemotherapy.

ImClone said it had asked the U.S. Food and Drug Administration to grant its marketing application a priority review, a designation that would ensure an answer from the agency within six months instead of the customary 10-month review period.

The New York-based drugmaker said its application was based on successful results of a late-stage trial involving 442 patients with previously untreated head and neck cancer. The trial showed that Erbitux, when added to current standard platinum-based chemotherapy, significantly increased the overall survival time for patients.

Note:
1. Reporting by Ransdell Pierson, editing by Maureen Bavdek

September, 2008|Oral Cancer News|