FDA sends complete response letter to Spectrum on its Evomela

The US Food and Drug Administration has issued a complete response letter to Spectrum Pharmaceuticals (Nasdaq: SPPI) on Evomela (melphalan) to treat multiple myeloma.

Spectrum said the FDA “did not identify any clinical deficiency” in its filing, made last December. The company plans to meet with the regulator to obtain clarification on the letter. Evomela is a propylene glycol-free melphalan formulation. Spectrum says it has demonstrated bioequivalence to the standard melphalan formulation Alkeran in a Phase II study. It has been granted orphan drug designation by the FDA for its use as a high-dose conditioning regimen in patients with multiple myeloma having autologous stem cell transplant.

Rajesh Shrotriya said: "we will work swiftly with the FDA to address the...letter... [we] remain committed to bringing Evomela to the market."