Spectrum has said in a SEC filing that the U.S. regulator rejected its application for Qapzola (apaziquone) in bladder cancer.
This comes after the FDA issued a complete response letter to the small cap biotech this week for its NDA.
In a brief update, the company’s SEC filing said: “On November 17, 2016, Spectrum Pharmaceuticals, Inc. (the “Company”) received a Complete Response Letter from the U.S. Food and Drug Administration (the “FDA”) with respect to the Company’s New Drug Application for QAPZOLA™ (apaziquone for intravesical instillation).
“On November 15, 2016, the Company met with the FDA to discuss the strategy for further development of QAPZOLA.”
It said that, based on its talks with the FDA, it was now “evaluating a new smaller study that would replace the ongoing Phase III program in which enrollment has been stopped. “
Further details about the FDA’s concerns that lead to its rejection have not been given.