The more scientists look, the more complex cancer seems to become.

British scientists said on Wednesday they had found a batch of new gene mutations linked to kidney cancer, suggesting even this apparently “straightforward” cancer type can be divided into subtypes requiring tailored treatment.

Clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer, stands out from other cancers because it is remarkably consistent and the majority of cases are known to be driven by mutations in a single gene, called VHL.

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Yet when researchers conducted a large DNA sequencing study of more than 3,500 genes from around 100 tumor samples, they found evidence that additional mutations in other genes were also driving cells to become cancerous.

Three of the genes were involved in modifying proteins called histones, which help package DNA into chromosomes and are critical to the functioning of cells, they reported in the journal Nature.

“Even in this clearest of cases, we see evidence for substantial genetic heterogeneity,” said Andy Futreal, co-leader of the Cancer Genome Project at the Wellcome Trust Sanger Institute in Cambridge.

While none of the new mutations accounted for more than 5 percent of cancer cases, the discovery should ultimately help in diagnosis and better selection of treatments for patients.

The latest findings underline the case for personalized medicine, or tailoring drugs to the genetic make-up of individual patients.

Scientists at the Sanger Institute last month also produced genetic “maps” identifying thousands of genetic mutations behind melanoma skin cancer and lung cancer.

Several personalized drugs are already used in cancer, including Roche’s Herceptin for breast cancer and AstraZeneca’s Iressa for lung cancer.

For drugmakers, tailored medicine is both an opportunity and a challenge as sub-dividing tumors by their molecular type shrinks the market for individual therapies.

Kidney cancer kills more than 100,000 people worldwide each year. Recent new drugs against the disease include Pfizer’s Sutent and Bayer’s Nexavar, which block cell proliferation and starve tumors of blood supply.

Source: Reuters

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AstraZeneca announced Wednesday that the European Commission approved its oral drug Iressa (gefitinib) for the treatment of adults with locally advanced or metastatic non-small-cell lung cancer with activating mutations of EGFR-TK, across all lines of therapy.

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The company’s executive vice-president for development, Anders Ekblom, remarked that the approval will give patients with EGFR mutation positive tumours “a more effective and better tolerated alternative to chemotherapy as a first-line treatment.” AstraZeneca also noted that it will conduct a follow-up study to generate more data on the drug’s effectiveness in a Caucasian population, and added that it was in discussions with the EMEA to finalise the study design. Iressa is currently sold in the Asia-Pacific region for patients with NSCLC who have received prior therapy.

Source: FirstWord

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Roche announced that the company will commence a late-stage trial investigating whether Tarceva (erlotinib) is superior to chemotherapy as a first-line treatment in patients with non-small-cell lung cancer (NSCLC) who have genetic mutations in their epidermal growth factor receptor (EGFR).

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News of the upcoming study comes after AstraZeneca said an EU committee adopted a positive opinion for Iressa (gefitinib) in adults with NSCLC with the same gene mutation. Commenting on the potential competition between the products, analyst Michael Leuchten of Deutsche Bank suggested that “we don’t doubt that Iressa will find its place in the treatment of non-small-cell lung cancer, but see little risk to the Tarceva franchise,” adding that “the two treatments are remarkably similar and entering a carved-up market without knock-out data is challenging.”

Deutsche Bank analysts said Iressa, which garnered sales of $250 million in 2008, will likely be a niche product, potentially generating $474 million in revenue in 2014.

Source: FirstWord

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AstraZeneca announced Thursday that a committee of the European Medicines Agency recommended approval for Iressa (gefitinib) in adults with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with activating mutations of EGFR-TK.

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The positive opinion stipulates, however, that the drugmaker must conduct a study to generate further data in a Caucasian population of patients with NSCLC. The drugmaker said it is in talks with the Committee for Medicinal Products for Human Use to finalise the design and endpoints of the trial.

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Phase III study findings published in the current issue of The Lancet show that AstraZeneca’s Iressa (gefitinib) demonstrated non-inferior survival compared with sanofi-aventis’ Taxotere (docetaxel) in patients with pre-treated advanced non-small-cell lung cancer (NSCLC). Lead author Edward Kim commented that “the study is the first time in lung cancer that an oral biological agent has been tested head-to-head against chemotherapy.”

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In the INTEREST study, 1466 patients were randomly assigned either Iressa, given orally once-daily, or Taxotere, administered intravenously every three weeks. Results showed that patients who took Iressa experienced median survival of about 7.6 months, versus 8 months in the Taxotere group. Moreover, after one year, 32 percent of Iressa patients were still alive, compared with 34 percent of those in the comparison group.

In an accompanying commentary, Michael Cullen, of University Hospital Birmingham, noted that Iressa has decreased toxicity compared with chemotherapy and is also available in a convenient formulation. “I think there will be patients for whom it will be favoured,” he noted.

Source: FirstWord

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