Most notably, we completed U.S. and Japanese filings for crizotinib in ALK-positive non-small cell lung cancer and U.S. and EU filings for axitinib in advanced renal cell carcinoma.
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Last April, Tarceva, promoted with OSI Pharmaceuticals (nasdaq: OSIP - news - people ), extended survival in non-small-cell lung cancer patients.
Pfizer found that a drug designed to harness the immune system to fight cancer was not effective in treating non-small-cell lung cancer.
This morning, the Food and Drug Administration announced that it had approved the AstraZeneca (nyse: AZN - news - people ) drug for treating advanced cases of non-small-cell lung cancer, which is the most common form of lung cancer in the United States.
Late in the trading day on Monday, March 14, Genentech shares were up 25% on volume more than triple its average for the past three months on news that data from a trial showed its cancer drug Avastin, approved to treat colorectal cancer since last year, extended lives of some patients with non-small-cell lung cancer an average of 2.3 months.
Among the bargain stocks, Berry says, is Cell Genesys (nasdaq: CEGE - news - people ), which has a number of products in late stage-three trials, including a vaccine for non-small cell lung cancer.
All of the doctors set a similar hurdle: If more than 5% of patients suffered life-threatening bleeding, it would be difficult to prescribe Avastin widely for non-small cell lung cancer.
Bayer and biotech Onyx Pharmaceuticals announced a devastatingly disappointing result for their cancer pill Nexavar: They stopped a study of the drug in non-small cell lung cancer early because there was no chance it would reach its main goal of proving Nexavar extends patients' lives in that disease.
The drug did seem to help non-small-cell lung cancer patients live slightly longer compared with a control group.
Additional studies will evaluate the effectiveness of the pill in glioblastoma, a lethal brain tumor, small-cell lung cancer and prostate cancer.
Wyeth's Torisel didn't help small-cell lung cancer patients in a 2007 trial.
At the end of two years, 22% of non-small-cell lung cancer patients who received Avastin with their chemotherapy were alive, compared to 17% who received only chemotherapy.
AstraZeneca's shocker Monday: Iressa, which had had an effect in 10% or more of non-small-cell lung cancer patients who had failed chemotherapy, did not seem to help at all when added to patients who were on chemotherapy.
Genentech's Avastin was tested with Taxol in non-small-cell lung cancer (see " Genentech's Triumph"), and can be used with either Eloxatin or Camptosar, which is made by Pfizer (nyse: PFE - news - people ).
However, on a July 31 conference call, Bristol's Cornelius said the deal had been inspired not just by the improving prospects for Erbitux, which recently had good study results in non-small-cell lung cancer, but also by the promising experimental cancer drugs ImClone has advanced over the past two years.
There are two other non-small cell lung cancer trials of Nexavar listed on clinicaltrials.gov.
He explained that she had a non-small cell lung cancer that had started in her left lung.
Recentin, for non-small cell lung cancer and colon cancer, will go to the FDA in 2009 or later.
Down the road, it could also gain approval for pancreatic, head and neck, and non-small cell lung cancer.
Zactima, for non-small cell lung cancer, should be filed with the Food and Drug Administration toward the end of next year.
One is crizotinib, for 5% of patients with non-small cell lung cancer.
Vandetanib, the drug approved today, failed in non-small cell lung cancer and in bladder cancer before it proved effective in medullary thyroid cancer.
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In trials unveiled in May, Iressa shrank tumors in 10% or more of patients with non-small cell lung cancer who had failed other chemotherapies.
The first data on Iressa were promising: It seemed to help patients with non-small cell lung cancer when it was given on its own.
Tarceva has already produced promising results in a trial on patients with non-small cell lung cancer who had already been heavily treated with chemotherapy.
In a study conducted with many patients in Japan, 28% of non-small cell lung cancer patients saw their tumors shrink with Iressa, compared with 10% of Caucasians.
Results in non-small cell lung cancer show that Abraxane does shrink tumors 31% better than Taxol, which the company says should be enough for an FDA approval in that disease.
It wasn't until Tarceva extended the lives of patients with non-small cell lung cancer that it became clear that OSI and Genentech actually did have a potential blockbuster on their hands.
The study, of patients with non-small cell lung cancer who were also receiving chemotherapy, showed an increase in "local failure, " meaning cancer cells at the radiation site either weren't killed or began growing.
Do Bayer and Onyx have the option of modifying these studies so that they might, given this new information, stand a better chance of proving a benefit for Nexavar in non-small cell lung cancer?
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