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news.Cell Therapeutics' shares have climbed over 9% after US regulators paved the way for a quick approval process for its lung cancer drug Xyotax.
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The decision came after the FDA examined data from a clinical trial into gender-specific lung cancer.
The US-based biopharmaceutical company announced that the FDA had agreed on a new drug application (NDA) route for Xyotax (paclitaxel poliglumex) for women with lung cancer.
The FDA agreed to review an NDA submission based on interim results of the Pioneer trial with the results of the Stellar 3 and 4 trials to support the filing. Based on this feedback, if the Pioneer trial meets its pre-specified interim endpoint, Cell plans to submit an NDA in the first half of 2007 and would request a priority (six month) review based on the fast track designation, instead of the standard (ten month) review as previously planned.
“We are happy with the outcome from our pre-NDA meeting with the FDA, which focused on how best to utilize the survival data observed among women in the Stellar 3 and 4 trials and confirmatory data from our ongoing gender- specific Pioneer trial,” stated Dr James Bianco, president and CEO at Cell.
“By reviewing an NDA based on interim data from the Pioneer study, this approach could reduce the approval process for this novel therapeutic by more than 12 months over a filing based on full results of the Pioneer study,” he added.