Melphalan regulatory update

FDA issued a complete response letter to Spectrum for an NDA for Evomela melphalan as a high-dose conditioning treatment in multiple myeloma (MM) patients undergoing autologous stem cell transplantation (ASCT) and for palliative treatment of MM patients for whom oral therapy is not appropriate. The company said FDA did not identify any clinical deficiency in the NDA package in the letter. The company plans to meet with the agency to seek clarification on the letter. The propylene glycol-free formulation of melphalan is delivered via Captisol sulfobutylether beta-cyclodextrin technology. ...