Spectrum says FDA declines to approve Evomela for injection

[October 23, 2015] (Reuters) - Biotechnology company Spectrum Pharmaceuticals Inc said the U.S. Food and Drug Administration declined to approve its Evomela injection to treat patients with multiple myeloma, a form of blood cancer that arises from plasma cells found in bone marrow.

Spectrum Pharmaceuticals said it received a complete response letter, which the FDA sends to let a drug developer know a marketing application will not be approved in its present form.

The FDA did not identify any clinical deficiency in its application, the company said.

"We remain committed to bringing EVOMELA to the market for patients and plan to work closely with the FDA," Chief Executive Rajesh Shrotriya said in a statement.

Spectrum, which acquires, develops and commercializes late-stage clinical and commercial drug compounds, gained development and commercialization rights to Evomela from Ligand Pharmaceuticals in March 2013. It filed a marketing application for the drug in December 2014.

(Reporting by Shivam Srivastava in Bengaluru; Editing by Anupama Dwivedi)

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