erbitux – Page 2 – Oral Cancer News

Third Head and Neck Indication for Erbitux

Source: The ASCO Post, January 1, 2012, Volume 3, Issue 1, Matthew Stenger In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.Cetuximab (Erbitux) was recently approved by the FDA for use in combination with platinum-based therapy plus fluorouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck.1-3 Cetuximab has prior indications in combination with radiation therapy in locally or regionally advanced squamous cell head and neck cancer and in recurrent or metastatic head and neck cancer that has progressed after platinum-based therapy. It also has indications in colorectal cancer. The most recent approval is based primarily on results of a study conducted outside the United States in 442 patients with metastatic or locally recurrent squamous cell carcinoma of the head and neck who were not suitable for curative treatment with surgery or radiation. The study used a European Union (EU)-approved cetuximab rather than the U.S.-approved cetuximab (Erbitux). Erbitux provides approximately 22% higher exposure than the EU-approved cetuximab; these pharmacokinetic data, together with the results of the study conducted in Europe and other data using Erbitux establish the safety and efficacy of Erbitux at the recommended dose.In this trial, the addition of cetuximab (n = 222) to platinum-based therapy plus 5-FU (n = 220) significantly increased median overall survival from 7.4 to 10.1 months, representing a 20% reduction in risk of death [...]

Oral Cancer Foundation News Team - A2012-01-07T17:15:00-07:00January, 2012|Oral Cancer News|

FDA Approves Cetuximab for Late-Stage Head and Neck Cancer

Source: The Oncology Report The Food and Drug Administration on Nov. 7 approved cetuximab as an initial treatment of late-stage head and neck cancer in combination with chemotherapy. Cetuximab, marketed as Erbitux by Bristol-Myers Squibb, is an epidermal growth factor receptor (EGFR) antagonist, administered as an intravenous infusion. Previously, it was approved in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma. It was also approved for use alone in patients with recurrent locoregional disease or metastatic disease whose disease has progressed following platinum-based chemotherapy. The newly approved indication is for the treatment of these recurrent or metastatic patients as an initial therapy in combination with platinum-based therapy with 5-fluorouracil (5-FU), a BMS spokesperson said. (At press time, the company had not yet issued a statement on the approval.) Erbitux was initially approved in 2004 to treat EGFR-positive late-stage colon cancer after patients stopped responding to chemotherapy and was approved in 2006 for the treatment of head and neck cancer. The newly approved indication is for "recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU," according to the revised label, posted on the FDA Web site. The two previously approved indications for head and neck cancer were for "locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy," and for "recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. [...]

Oral Cancer Foundation News Team - A2011-11-09T11:05:16-07:00November, 2011|Oral Cancer News|

US FDA approval for expanded use of Erbitux

Source: www.pharmabiz.com Author: staff The US Food and Drug Administration (FDA) has approved Erbitux (cetuximab), in combination with platinum-based chemotherapy with 5-fluorouracil (CT), for the first-line treatment of recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN). The approval, which is based on data from the landmark EXTREME (ErbituX in first-line Treatment of REcurrent or MEtastatic head & neck cancer) trial, makes Erbitux plus CT the first treatment regimen approved in 30 years with extended overall survival in patients with recurrent locoregional or metastatic SCCHN. Erbitux (cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumour cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITU Erbitux GFR blocks phosphorylation and activation of receptor-associated kinases, resulting in induction of apoptosis (cell death), inhibition of cell growth, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, Erbitux can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. In vitro assays and in vivo animal studies have shown that Erbitux inhibits the growth and survival of tumour cells that express the EGFR. No anti-tumour effects of Erbitux were observed in human tumour xenografts lacking EGFR expression. EXTREME, which was previously published in the New England Journal of Medicine, was a phase III open label, randomized, multi-centre, controlled trial. This study was conducted outside the US by [...]

Oral Cancer Foundation News Team - A2011-11-09T06:24:41-07:00November, 2011|Oral Cancer News|

FDA Approves Cetuximab for Metastatic Head and Neck Cancer

Source: MedScape News Today The US Food and Drug Administration (FDA) has approved cetuximab (Erbitux, Bristol-Myers Squibb ) for use in combination with chemotherapy for the treatment of metastatic head and neck cancer. Data show that when combined with cisplatin-based chemotherapy, cetuximab improved overall survival, compared with chemotherapy alone. According to the researchers, this is the first time in 3 decades — since cisplatin was first used in head and neck cancer — that any regimen has improved on its success. The improved survival that was seen after cetuximab was added to the regimen (at a median of 2.7 months) is "therefore notable." Cetuximab was approved in the United States in 2004 for the treatment of epidermal growth-factor receptor–positive late-stage colon cancer in patients who no longer responded to chemotherapy. In 2006, it was approved for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. This latest approval expands on that to cover metastatic head and neck cancer. The ability of cetuximab "to extend the lives of patients with head and neck cancer is an important tool for oncologists, who often rely on a multitreatment approach for patients," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, in a statement." Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have [...]

Oral Cancer Foundation News Team - A2011-11-08T12:00:48-07:00November, 2011|Oral Cancer News|

Cancer drug resistance strategy uncovered

Source: Cancer Research UK Author: Staff Friday 9 September 2011- US scientists have identified a way in which cancer cells can become resistant to the cancer drug cetuximab (Erbitux), and suggest that treatments that are already available might be able to overcome this resistance. Researchers from the Dana-Farber Cancer Institute in Boston, US, have been studying why some patients only experience short-term benefits with cetuximab, or none at all. Cetuximab is an antibody that interferes with cancer cell growth. It can be given in combination with chemotherapy to patients with bowel cancer or head and neck cancer. Until now, scientists didn't know why some cancers failed to respond to the drug, or initially responded but then became resistant. The new study, published in Science Translational Medicine, found that in some of the drug-resistant cells, a protein known as ErbB2 (also known as HER2/neu) was sending 'grow' signals. These were bypassing the 'stop growing' signals caused by the drug. Pasi Janne, the study's co-senior author, said: "ErbB2 activates a critical signalling pathway that is not normally blocked by cetuximab, and in this way subverts cetuximab's function. "Because ErbB2 isn't affected by cetuximab, this is an easy way for cancers to become resistant to the drug." The researchers suggest that combining cetuximab with already available ErbB2 inhibitors such as trastuzumab (Herceptin) could produce an effective therapy to tackle cancers that previously showed resistance to cetuximab. Henry Scowcroft, science information manager at Cancer Research UK, said: "Unfortunately, patients's tumours can become resistant to treatment, and understanding why this happens is a [...]

Charlotte Parker2011-09-09T12:20:44-07:00September, 2011|Oral Cancer News|

Strategy to conquer cancer drug resistance uncovered

Source: info.cancerresearchuk.org Author: staff US scientists have identified a way in which cancer cells can become resistant to the cancer drug cetuximab (Erbitux), and suggest that treatments that are already available might be able to overcome this resistance. Researchers from the Dana-Farber Cancer Institute in Boston, US, have been studying why some patients only experience short-term benefits with cetuximab, or none at all. Cetuximab is an antibody that interferes with cancer cell growth. It can be given in combination with chemotherapy to patients with bowel cancer or head and neck cancer. Until now, scientists didn't know why some cancers failed to respond to the drug, or initially responded but then became resistant. The new study, published in Science Translational Medicine, found that in some of the drug-resistant cells, a protein known as ErbB2 (also known as HER2/neu) was sending 'grow' signals. These were bypassing the 'stop growing' signals caused by the drug. Pasi Janne, the study's co-senior author, said: "ErbB2 activates a critical signalling pathway that is not normally blocked by cetuximab, and in this way subverts cetuximab's function. "Because ErbB2 isn't affected by cetuximab, this is an easy way for cancers to become resistant to the drug." The researchers suggest that combining cetuximab with already available ErbB2 inhibitors such as trastuzumab (Herceptin) could produce an effective therapy to tackle cancers that previously showed resistance to cetuximab. Henry Scowcroft, science information manager at Cancer Research UK, said: "Unfortunately, patients's tumours can become resistant to treatment, and understanding why this happens is a major [...]

Oral Cancer Foundation News Team - A2011-09-09T05:32:14-07:00September, 2011|Oral Cancer News|

Hypersensitivity Reactions to Erbitux Caused by Tick Bites.

Source: Gastroenterology & Endoscopy News Hypersensitivity reactions to cetuximab (Erbitux, ImClone Systems/Bristol-Myers Squibb), a monoclonal antibody approved for use in colorectal cancer, are not caused by the drug itself but by preexisting immunoglobulin E (IgE) antibodies that may result from tick bites, researchers have found. Cetuximab, like other monoclonal antibodies, is generally associated with a low rate of severe anaphylactic reactions (3%), but reports of such reactions to cetuximab have recently increased in southeastern states, including Tennessee and North Carolina. Researchers found IgE antibodies in pretreatment samples of 68% of patients allergic to cetuximab that were specific for galactose-α-1,3-galactose, an oligosaccharide present on the Fab portion of the cetuximab heavy chain. The authors noted that rates of anaphylactic reaction may be lower with other monoclonal antibodies because cetuximab is produced in the mouse cell line SP2/0, which expresses this oligosaccharide, whereas most other monoclonal antibodies are produced in a Chinese hamster ovary cell line that does not express this molecule. Theories to explain the increased hypersensitivity of patients in the Southeast initially centered on exposure to worms, such as roundworms or tapeworms. However, researchers now believe the true culprit may be ticks, whose bites have resulted in the development of this type of IgE antibody. Pretreatment samples were obtained from 76 people treated with cetuximab at centers mainly in Tennessee, Arkansas and North Carolina; the control group included 72 people in Tennessee, 49 patients with cancer in northern California and 341 women in Boston. Of the patients on cetuximab, 25 [...]

Oral Cancer Foundation News Team - A2011-07-01T12:42:28-07:00July, 2011|Oral Cancer News|

HPV and EGFR are hottest topics in head and neck cancer

Source: www.medscape.com Author: Zosia Chustecka The hottest topic in head and neck cancers is the role of human papillomavirus (HPV) in the disease, although there is also a lot interest in treatment with EGRF inhibitors, especially the second-generation products, according to an expert here at the European Society for Therapeutic Radiology and Oncology 11th Biennial Conference. HPV has only been associated with head and neck cancer in the last few years, but it is now clear that patients who are positive for the virus have a better prognosis, said Cai Grau, MD, DMSC, professor of oncology at Aarhus University Hospital, Denmark. He chaired a session during which both hot topics were discussed. "These patients have a better prognosis, irrespective of treatment, and their risk of a second cancer is virtually zero," added session participant Lisa Licitra, MD, medical oncologist at the Istituto Nazionale per lo Studio e la Cura dei Tumori in Milan, Italy. However, there is a difference between patients in the United States and those in Europe with regard to risk, she told meeting attendees. For American patterns, Dr. Licitra cited the analysis published last year in the New England Journal of Medicine (2010;363:24-35), which reported a risk model for death from oropharyngeal squamous cell carcinoma on the basis of HPV status, pack-years of tobacco smoking, and tumor and nodal stage. In this 266-patient cohort, 43% were low risk, 30% were intermediate risk, and 27% were high risk. Dr. Licitra reported that when she performed the same analysis [...]

Oral Cancer Foundation News Team - A2011-05-17T06:56:01-07:00May, 2011|Oral Cancer News|

ASCO: Non-platinum regimen works in head, neck cancer

Source: www.medpagetoday.com Author: Michael Smith, North American Correspondent, MedPage Today A novel non-platinum-based regimen was efficacious in recurrent or metastatic squamous cell head and neck cancer, researchers said. The combination of pemetrexed (Alimta) and bevacizumab (Avastin) yielded a response rate of 30% in a small single-arm trial, according to Athanassios Argiris, MD, of the University of Pittsburgh, and colleagues. The combination also increased the length of time before patients progressed, and increased median overall survival, Argiris and colleagues reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology here. Patients with recurrent or metastatic disease typically have a poor prognosis, the researchers said, with median survival between six and nine months with standard chemotherapy. But, in other research, adding the monoclonal antibody cetuximab (Erbitux) to platinum-based chemotherapy increased survival, they said. Bevacizumab is a monoclonal antibody that targets the vascular epithelial growth factor (VEGF), which is expressed in squamous cell head and neck cancer; high levels of VEGF correlate with poor outcome, they noted. The researchers hypothesized that the antibody might enhance the activity of pemetrexed, which is a multi-targeted antifolate indicated for malignant pleural mesothelioma and non-small cell lung cancer. To test the idea, they analyzed results of treating 37 patients given 500 mg/m2 of pemetrexed and 15 mg/kg of bevacizumab intravenously every 21 days until disease progression. Patients were also given folic acid and vitamin B12. The primary endpoint of the study was time to progression, they said, but the researchers [...]

Oral Cancer Foundation News Team - A2010-06-06T07:32:19-07:00June, 2010|Oral Cancer News|

ASCO: Antibody improves head and neck cancer results

Source: www.medpagetoday.com Author: Michael Smith, North American Correspondent, MedPage Today A novel antibody improved outcomes for patients with advanced and inoperable squamous cell carcinoma of the head and neck, researchers reported. Combined with radiation or chemoradiation, the substance -- a fully humanized monoclonal antibody dubbed nimotuzumab -- significantly outperformed either modality alone in an open-label randomized trial, according to K. Govind Babu, MD, of Kidwai Memorial Institute of Oncology in Bangalore, India, and colleagues. At the same time, there was little serious toxicity -- such as debilitating skin rash -- attributed to the compound, the researchers reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology here. It's the first randomized study of the drug to show clinical benefit without the toxicities associated with similar antibodies, the researchers said. In general, neither radiation nor chemotherapy provides a good outcome for patients with inoperable stage III or IVa squamous cell carcinoma of the head and neck. However, substances such as cetuximab (Erbitux) that target the epidermal growth factor receptor (EGFR) -- overexpressed in such tumors -- have improved outcomes. Nimotuzumab, like cetuximab, targets EGFR, but is highly selective for tumor tissues, limiting toxicity, the researchers said. The study enrolled 92 patients, and 76 were evaluable for efficacy. They were treated with radiation or chemoradiation (with cisplatin), with or without nimotuzumab. The substance was given by intravenous infusion of 200 milligrams over a 60-minute period, once a week for six weeks. In group A -- [...]

Oral Cancer Foundation News Team - A2010-06-06T07:24:13-07:00June, 2010|Oral Cancer News|