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news.Development stage biopharmaceutical company Puma Biotechnology has commenced Phase III trial of PB272 (neratinib) in patients with third-line HER2-positive metastatic breast cancer.
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Around 600 patients are expected be enrolled in the study and will be randomized with PB272 plus Xeloda or Tykerb plus Xeloda.
Puma Biotechnology chief executive officer and president Alan Auerbach said, "We look forward to aggressively enrolling this trial and to pursuing additional registration opportunities for PB272 in HER2-positive breast cancer and in tumors with a mutation in the HER2 kinase, including non-small cell lung cancer, breast cancer and the other solid tumors that we will be studying in our upcoming basket trial."
Progression free survival and overall survival are the co-primary endpoints of the trial, which is anticipated to be conducted at around 150 sites in North America, Europe and Asia-Pacific.
Based on the progression free survival data, the company plans to submit a new drug application to the FDA for accelerated approval of PB272 and market authorization application to the European Medicines Agency for conditional approval of PB272.