erbitux – Page 4 – Oral Cancer News

Update FDA seeks more Erbitux data on head and neck cancer

Source: www.reuters.com Author: Ransdell Pierson U.S. regulators have declined to approve use of Erbitux as a first-line treatment for head and neck cancer until a new U.S. animal study is conducted showing how the medicine is absorbed by the body, drugmakers Eli Lilly and Bristol-Myers Squibb said on Monday. Lilly and Bristol-Myers had asked the U.S. Food and Drug Administration to approve first-line use of Erbitux based on favorable head and neck cancer data from overseas studies conducted by German drugmaker Merck KGaA. Merck sells Erbitux outside the United States. Lilly separately makes Erbitux and sells it in the United States in partnership with Bristol-Myers. The FDA wants an additional study to ascertain that both batches of Erbitux have the same pharmacokinetic profile, meaning the drug is absorbed in the bloodstream in similar fashion and amounts, said Lilly spokeswoman Judy Kay Moore. "They want an additional preclinical trial to study comparability" of Erbitux batches, Moore said. Lilly and Bristol-Myers recently withdrew their U.S. application to market Erbitux for advanced non-small cell lung cancer because of the same need to confirm comparability of batches made in different plants. "Essentially we will do one animal study and that will answer the pharmacokinetic comparability questions related to first-line treatment for both head and neck and lung cancer," Moore said. Lilly hopes to refile the lung cancer marketing application in the second half of 2009, Moore said. She said the company does not need to refile its application for first-line treatment of head and [...]

Oral Cancer Foundation News Team - A2009-03-02T12:42:43-07:00March, 2009|Oral Cancer News|

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 [...]

Oral Cancer Foundation News Team - A2009-02-07T13:44:11-07:00February, 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 [...]

Oral Cancer Foundation News Team - A2009-01-24T08:51:35-07:00January, 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.

Oral Cancer Foundation News Team - A2008-11-23T09:40:56-07:00November, 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 [...]

Oral Cancer Foundation News Team - A2008-11-06T19:54:40-07:00November, 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 [...]

Oral Cancer Foundation News Team - A2008-10-15T06:32:49-07:00October, 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) [...]

Oral Cancer Foundation News Team - A2008-09-15T22:10:24-07:00September, 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

Oral Cancer Foundation News Team - A2008-09-04T16:24:01-07:00September, 2008|Oral Cancer News|