Positive Phase III data have led Roche to submit a label-extension application to the EMEA for use of Herceptin in HER2-positive advanced gastric cancer. The company said it plans to submit label-extension applications in other countries as soon as possible.

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The application follows a detailed analysis of data from the Phase III ToGA trial, which involved 594 stomach cancer patients who were positive for HER2. The results showed that in comparison with standard chemotherapy alone (Xeolda or intravenous 5-FU and cisplatin), the addition of Herceptin to chemotherapy increased overall survival by 2.7–13.8 months and led to a 26% reduction in the risk of death. For patients with particularly high levels of HER2, average survival increased from 11.8 months to 16 months when Herceptin was added to chemotherapy.

Roche says about 16% of stomach tumors express high levels of HER2. “It is now clearly proven that Herceptin prolongs the lives of patients suffering from HER2-positive gastric cancer,” according to Trial investigator, professor Eric Van Cutsem, M.D., at the University Hospital Gatsthuisberg, Leuven (Belgium). “The results of the ToGA study reinforce the need for early and accurate HER2 testing of all advanced gastric cancer patients.” The ToGA trial data were presented at 15 ECCO ESMO 34 in Berlin.

Soure: GEN News

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New Phase III trial data suggests giving colon cancer patients Roche’s oral anticancer drug Xeloda in combination with intravenous oxaliplatin immediately after surgery boosts disease-free survival compared with combined postsurgery chemotherapy using 5-fluorouracil/leucovorin.

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The open-label international trial included 1,886 patients with stage III colon cancer who underwent surgery for their cancer. Roche says that it plans to use this data to apply for an extension to the Xeloda label.

Xeloda was first approved as first-line monotherapy for metastastic colorectal cancer in the U.S. and EU in 2001. Since then the drug has been sanctioned in a number of other countries for use as either monotherapy or in combination with other chemotherapies for the treatment of metastatic colorectal, breast, and pancreatic cancers, as well as advanced gastric cancer.

In 2008 Xeloda represented Roche’s eight best-selling pharmaceutical, with sales for that year reaching CHF 1.2 billion ($1.12 billion), up 13% from 2007. Growth in Japan was particularly strong, with sales in this market up 74%.

Source: GEN News

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Roche reported that Herceptin (trastuzumab) decreased the risk of death in patients with HER2-positive advanced stomach cancer by 26 percent, compared to chemotherapy alone, according to findings from a Phase III study. The additional details, presented at ASCO, follow the company’s announcement earlier this year that the trial had met its primary endpoint of improving overall survival. ASCO’s president, Richard Schilsky, remarked that the data will change medical practice and “will force us to test patients for HER2, treat patients who are HER2-positive, and conduct research on gastric cancer that is HER2-positive.”

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The randomised ToGA study enrolled 594 patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer, who received first-line treatment with either Herceptin plus chemotherapy, or chemotherapy alone. Data showed that patients in the Herceptin arm had a median overall survival time of 13.8 months, compared to 11.1 months for those in the chemotherapy-only group. Furthermore, Roche stated that patients with tumours exhibiting high levels of HER2 lived 16 months on average when Herceptin was added to treatment with chemotherapy.

Principal investigator Eric Van Cutsem commented that “this is the first Phase III study to report improved overall survival with a personalised, targeted treatment for gastric cancer” and “the first time a biological [drug] has improved survival in gastrointestinal cancer.” He also noted that Herceptin reduced the size of tumours and increased survival significantly beyond the one-year mark that has been a hurdle for patients with advanced gastrointestinal tumours.

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Corinne Wolter remarked that the drugmaker will file Herceptin, which is currently approved for the treatment of breast cancer, for regulatory approval in the stomach cancer indication in countries outside the US. Spokesperson Kristina Becker of Genentech said a decision to file for expanded approval with the FDA is under review. Nomura analyst Amit Roy estimated that approval of Herceptin in patients with HER2-positive stomach cancer could add $450 million to the product’s annual worldwide sales, which exceeded $4.7 billion last year.

Source: FirstWord

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Novartis announced Monday that the FDA approved its mTOR inhibitor Afinitor (everolimus) for patients with advanced renal cell carcinoma whose disease has progressed after treatment with other cancer therapies. Joe Jimenez, CEO of Novartis Pharma, remarked that “Afinitor is a drug that really has the potential to treat many different cancers…This will be a substantial drug for Novartis.”

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The company said the approval was based on late-stage RECORD-1 data showing that Afinitor more than doubled the time without tumour growth or death in patients with advanced kidney cancer, and reduced the risk of disease progression or death by 67 percent, compared to placebo. The FDA specified that the drug is intended for patients who have already tried Pfizer’s Sutent (sunitinib) or Bayer’s and Onyx’s Nexavar (sorafenib).

Jimenez added that Novartis believes Afinitor “has the potential to be a blockbuster and that’s before we even get to breast cancer, gastric cancer and non-small-cell lung cancer.” The compound has been submitted to regulators in the EU, Switzerland and Japan, as well as in other countries.

Source: FirstWord

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Roche announced Phase III study results on Wednesday which demonstrated that the use of Herceptin (trastuzumab) in combination with standard chemotherapy significantly prolonged overall survival in patients with HER2-positive advanced gastric cancer, compared with chemotherapy alone. William Burns, head of Roche’s pharmaceutical division, remarked that “the ToGA study shows for the first time that Herceptin extends the lives of patients in a cancer other than breast cancer.”

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The trial enrolled 594 patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer. The patients were randomised to receive first-line treatment with Herceptin in combination with chemotherapy, or chemotherapy alone. The primary endpoint was overall survival, while secondary endpoints included progression-free survival and overall response rate, Roche noted.

The drugmaker stated that complete results will be presented at an upcoming medical conference.

Source: FirstWord

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