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Avastin is an anti-VEGF antibody, already available in the EU for the treatment of colorectal, breast, non-small-cell lung, and kidney cancers. Approval for the metastatic RCC indication was granted in the EU during 2007.  The drug has been cleared in the U.S. for the treatment of the same advanced cancers as well as also glioblastoma.

Avastin is currently Roche’s second biggest selling pharmaceutical, behind Rituxan/MabThera). Sales of the drug in 2008 reached CHF 5.2 billion (roughly $7.5 billion), up 37% from 2007. Avastin represented some 15% of all Roche’s pharma sales for that year. Particularly strong growth for Avastin in non-U.S. markets, where 2008 sales were up 67%, was largely due to increased use in metastatic breast cancer, Roche notes.

At the end of 2008, the global development program for Avastin included some 450 clinical trials.  Commenting on today’s approval, William M Burns, CEO of Roche’s pharmaceuticals division, says, “This underscores our belief in the important clinical benefits that Avastin delivers as we push forward with our ongoing research programs in more than 30 tumor types.”

Source: GEN News

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Data from the AVADO study, a Phase III trial of the drug combination in 736 patients, showed improvement in progression-free survival with use of the drug in combination with Taxotere, compared with Taxotere alone.

Avastin is approved in the EU for first-line treatment of patients with advanced breast cancer in combination with paclitaxel, and for the treatment of advanced stages of colorectal, kidney, and non-small-cell lung cancers.

Source: FirstWord

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Avastin is already approved in Europe, in combination with paclitaxel, as a first-line treatment for patients with metastatic breast cancer. The drugmaker said the positive opinion for the combination of Avastin plus Taxotere was based on Phase III data from the 736-patient AVADO study, which showed that those given Avastin plus sanofi-aventis’ chemotherapy drug experienced increased progression-free survival, compared with Taxotere alone.

Avastin is also cleared for use in Europe to treat advanced stages of colorectal, kidney, and non-small-cell lung cancers.

Source: FirstWord

The findings, published in the journal Nature, double the number of genes already linked with lung adenocarcinoma, a type of non-small cell lung cancer that accounts for 40 percent of the more than 1 million lung cancer deaths each year.

“We think that our study may achieve a real impact on the cure of lung cancer patients,” Dr. Matthew Meyerson of the Broad Institute of Massachusetts Institute of Technology and Harvard University said in a telephone briefing.

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Meyerson was part of an international team that decoded 623 genes from tumors in 188 lung cancer patients and compared these to genes from normal tissues from the same people.

They found 26 genes that were most commonly altered in the tumors, most of which had never been linked with lung cancer. Some had been found in other types of tumors.

The new genes included mutations in neurofibromatosis 1, a gene known to cause a rare neurological disorder and raise the risk of nerve and brain tumors; ataxia telengiectasia mutated or ATM, which has ties with leukemia and lymphoma; retinoblastoma 1, which is linked with a rare childhood cancer of the eye; and adenomatosis polyposis coli or APC, which is common in colon cancer.

Many of the mutated genes also share common biological pathways or gene networks.

“Looking at the pathways helps simplify the picture,” said Richard Wilson of Washington University in St. Louis, who helped lead the project.

PROMISING DRUGS

One of the most promising of these pathways is the mitogen-activated protein kinase or MAPK pathway, altered in more than 70 percent of the tumors. Drug compounds called MEK inhibitors that affect this pathway have already shown promise in mice with lung cancer.

About half of the tumors had defects in the p53 pathway, which is critical for suppressing tumor growth. Companies such as Introgen Therapeutics Inc are working on drugs that affect this pathway.

Some 30 percent of the tumors had mutations in the mTOR pathway, raising hope that drugs that inhibit the mTOR protein might help some lung cancer patients. Swiss drugmaker Novartis’ mTOR inhibitor for kidney cancer, Afinitor, is currently under review by U.S. regulators.

The researchers also saw that a familiar class of genes known as tyrosine kinases, which trigger cell growth, played a key role in lung tumors. Gene families in this group include EGFR and VEGF.

Genentech and Roche Holding AG’s drug Avastin targets VEGF, while their pill for advanced lung cancer called Tarceva interferes with EGFR. A recent study found combining the two did little to help lung cancer patients live any longer.

Meyerson said genetic testing may help determine which patients might benefit from current drugs, but he said many new drugs will likely come from the findings as well.

“Probably, we will need a lot more drugs. What’s great is we’ve identified many new drug targets,” he said.

Some analysts predict the market for non-small cell lung cancer could exceed $4 billion between 2010 and 2015.

Source: Reuters

Under the deal, the cost of administering the drug and managing side effects will be about $10,600 per patient, Dow Jones Newswires reports. That figure is comparable to the cost of administering Taxotere, a cancer drug sold by Sanofi-Aventis, and it’s a discount of more than $1,000 from the Tarceva’s standard price.

Last year, Johnson & Johnson made a creative deal with NICE, the U.K. body that decides what drugs are worth the money: J&J said it would cover the cost of Velcade for multiple myeloma patients who did not benefit from the drug.

Other cancer drugs simply haven’t cleared the bar. This summer, NICE said a whole new crop of drugs for kidney cancer were too expensive for the benefit they provide. The drugs — Pfizer’s Sutent, Wyeth’s Torisel, Nexavar from Onyx and Bayer and Avastin from Roche and Genentech — typically cost around $50,000 per patient and extend patients’ lives by a few weeks or months, on average.

Source: The Wall Street Journal