FDA rejects Spectrum’s bladder cancer med, may retool study

The FDA has sent a complete response letter to the biotech

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).


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

“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. 

Suggested Articles

The FDA warned healthcare providers about cybersecurity vulnerabilities within certain clinical information systems made by GE Healthcare.

Weeks after receiving FDA approval for its in-office eardrum tube device, Tusker Medical has been picked up by Smith & Nephew for an undisclosed sum.

What a difference a day makes in biotech.