Pharmacyclics announced today that the Food & Drug Administration (FDA) has granted priority review for the company's oral cancer-treating Ibrutinib drug. With the filing review out of the way, Pharmacyclics' new drug application puts Ibrutinib one step closer to regulatory approval.
The drug was jointly developed with Johnson & Johnson's Janssen Biotech division, and the FDA's most recent approval puts $75 million into Pharmacyclics' pocket per a collaboration agreement between the two corporations.
"We are very excited to have received the official FDA acceptance of our first NDA filing for ibrutinib," said Pharmacyclics Senior Vice President of Global Regulatory Affairs Dr. Urte Gayko in a statement today. "We look forward to continuing to work with the FDA as they complete their review of the ibrutinib application which includes the new Breakthrough Therapy Designation process."
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