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).

Whitepaper Download

Reducing the Complexity and Costs of Channel Planning and Logistics

How can you make the process of bringing your product to market less complex while also reducing costs? This Whitepaper identifies opportunities to simplify channel strategies for biopharma companies, their customers and patients. Discover how you can deliver savings and innovation to your business.

“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

Bristol Myers Squibb may have bounced Jounce from its roster of inherited partners, but it’s hanging onto Anokion, a Swiss autoimmune-focused biotech.

The immunoassay will measure neurofilament light chain protein levels, found in the blood and cerebrospinal fluid, and linked to nerve damage.

The priority review action date sets Bristol Myers up to win approval for the bluebird-partnered anti-BCMA CAR-T therapy in late March.