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Spectrum Pharmaceuticals' Evomela Gets CRL in the U.S.

Spectrum Pharmaceuticals, Inc.SPPI announced that it has received a Complete Response Letter (CRL) from the FDA for Evomela.

The company is looking to get Evomela approved as a high-dose conditioning treatment prior to stem cell transplantation in patients suffering from multiple myeloma (MM) and for the palliative treatment of MM patients for whom oral therapy is not appropriate.

The company reported that no clinical deficiency was mentioned in the letter. The company plans to hold a meeting with the FDA and seek clarification on the CRL.

We remind investors that Spectrum Pharma had acquired global development and commercialization rights to Evomela from Ligand Pharmaceuticals Inc. LGND in 2013. Under the terms of the agreement, Ligand received license fees and is eligible to receive milestone payments and royalties on sales.

Evomela has Orphan drug status in the U.S. as a high-dose conditioning regimen for patients with MM undergoing autologous transplantation (ASCT).

According to the American Cancer Society, in the U.S. nearly 27,000 new cases of MM are projected in 2015 till date with over 11,000 deaths. The growth rate of ASCT in MM patients is approximately 3.3% on an annual basis.

Meanwhile, Spectrum Pharma continues to progress on its pipeline. Currently, the company is evaluating SPI-2012 (a phase III study to be initiated in 2015) for the treatment of chemotherapy induced neutropenia and poziotinib (multiple phase II studies) for the treatment of breast cancer. Moreover, the company is on track with an NDA filing for apaziquone by 2015-end for the treatment of non-muscle invasive bladder cancer as a single instillation following transurethral resection of bladder tumor.

Spectrum Pharma carries a Zacks Rank #2 (Buy). Other favorably ranked stocks in the health care sector include AstraZeneca PLC AZN and Amgen Inc. AMGN , each sporting a Zacks Rank #1 (Strong Buy).

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SPECTRUM PHARMA (SPPI): Free Stock Analysis Report

ASTRAZENECA PLC (AZN): Free Stock Analysis Report

AMGEN INC (AMGN): Free Stock Analysis Report

LIGAND PHARMA-B (LGND): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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