AstraZeneca’s string of regulatory successes has been broken–snapped by its decision to pull marketing applications in the U.S. and Europe for the cancer drug Zactima.

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Named by Fitch Ratings as one of AstraZeneca’s most promising late-stage products, Zactima (vandetanib) was scuttled by an updated analysis which failed to demonstrate an added survival benefit when the drug was added to chemotherapy for patients with non-small cell lung cancer. Regulators provided the final push by suggesting that an application that relied on progression-free survival data–rather than overall survival–might not warrant an approval.

AZ will complete two ongoing trials for thyroid and lung cancer in the next few months to get a clearer picture of the drug’s prospects “in different clinical settings.” Like Avastin, Zactima is a VEGF inhibitor designed to starve tumors of blood.

Source: FierceBiotech

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Results from a small study published in the NEJM showed that Roche’s Avastin (bevacizumab) decreased the size of benign tumours in most patients with neurofibromatosis type 2 (NF2) and alleviated other complications associated with the rare genetic condition that can lead to hearing loss. Lead author Scott Plotkin commented that “our study is the first to provide evidence that a drug can shrink vestibular schwannomas – benign tumours on the balance and hearing nerves – and the first to show that patients’ hearing can be improved.”

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In the study, 10 patients with progressive NF2 and progressive vestibular schwannomas who were not candidates for standard treatment with surgery or radiation were administered Avastin intravenously every two weeks for a median duration of 12 months. Researchers found that treatment resulted in tumour shrinkage in nine patients. Six individuals achieved a decrease in tumour volume of at least 20 percent from baseline, with four maintaining the response during 11 to 16 months of follow-up, investigators noted.

Additionally, the study found that of the seven patients who began losing their hearing prior to the start of the trial, four regained some hearing, which was maintained for up to 16 months, while two had stable hearing and one experienced progressive hearing loss.

Plotkin indicated that based on the study’s results, researchers have started recruiting patients for a clinical trial of PTC Therapeutics’ VEGF inhibitor, PTC299, as a potential treatment for NF2. The oral compound, Plotkin said, may be easier to administer than Avastin and may also cause fewer side effects.

Source: FirstWord

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