On October 23, 2015 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) (Press release, Spectrum Pharmaceuticals, OCT 23, 2015, View Source [SID:1234507771]). A Complete Response Letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA did not identify any clinical deficiency in Spectrum’s NDA package.

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"We will work swiftly with the FDA to address the Complete Response Letter," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We remain committed to bringing EVOMELA to the market for patients and plan to work closely with the FDA."

Spectrum Pharmaceuticals gained global development and commercialization rights to EVOMELA from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013. Spectrum assumed responsibility for completing the pivotal Phase 2 clinical trial, and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.