Spectrum Pharmaceuticals (SPPI) recently received encouraging news in the form of the acceptance of its supplemental New Drug Application (sNDA) for cancer candidate Fusilev (levoleucovorin). The application has been considered as a Class II re-submission, implying an early response within 6 months (target date: April 29, 2011).
Spectrum Pharma is looking to expand the label of Fusilev, an injectable drug, and get it approved as a combination therapy in patients suffering from advanced metastatic colorectal cancer.
Spectrum Pharma had received a complete response letter (CRL) for the candidate in October 2009. While the US regulatory body asked the company to submit additional data, the company was not asked to conduct additional efficacy studies. Spectrum Pharma submitted its response to the CRL in October 2010.
We note that Fusilev is already available in US markets since 2008 for rescue in osteosarcoma (a form of bone cancer) patients following treatment with a high-dose of chemotherapy drug, methotrexate. Fusilev is also approved to diminish the toxic effects of methotrexate and counteract the effects of impaired methotrexate elimination and unintentional excessive dosage of folic acid antagonists.
In ex-US territories, Fusilev has been marketed for more than a decade by Wyeth (now a part of Pfizer (PFE)) , Sanofi-Aventis (SNY) and Takeda, among others.
Apart from Fusilev, Spectrum Pharma’s other FDA approved product is Zevalin, which is for treating patients suffering from non-Hodgkin’s lymphoma (NHL). Moreover, the company has a deep pipeline primarily focusing on oncology and hematology. The successful development and commercialization of the robust pipeline would help drive long-term growth at Spectrum Pharma.
Moreover, the company’s efforts to expand Fusilev’s label are also encouraging. Approval for the additional indication would help drive revenues of the product.
Currently, we are Neutral on Spectrum Pharma which is supported by the Zacks#3 Rank (‘short-term Hold rating) carried by the company.
PFIZER INC (PFE): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
SPECTRUM PHARMA (SPPI): Free Stock Analysis Report
Zacks Investment Research
