From Seeking Alpha
This Friday, April 29, 2011 Spectrum Pharmaceuticals (SPPI) will announce whether the FDA will approve its supplemental new drug application (sNDA) for Fusilev (levo-leucovorin) which is indicated for metastatic colorectal cancer (mCRC).
As argued back on February 16, 2011, I think the FDA is likely to approve the treatment.
Last Thursday, April 21, SPPI announced that the FDA approved the company’s sNDA for a ready-to-use version of Fusilev (RTU) under the approved osteosarcoma indication.
With a serious short supply of generic leucovorin, it looks like US regulators decided to go ahead and approve the RTU version several months in advance in order to offer additional supplies to a very needy market. Presuming supplies of Fusilev RTU exist, patients will now have access to treatment. From my view, the early RTU approval is a big deal and suggests that Friday (April 29) will likely be a good day for SPPI and their shareholders.
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PART II. THE SHORTAGE
In April 2010, Teva Pharmaceuticals (TEVA) voluntarily stopped making generic leucovorin and other injectable cancer drugs due to manufacturing issues at the company’s plant in Irvine, California. As result, the second leucovorin shortage within the past three years was ignited. According to the FDA, the current shortage began in June 2010.
Fast forward one year later – the leucovorin shortage continues to be a major problem. Patients are not receiving adequate treatment. Last month, the FDA characterized the current leucovorin shortage as “severe” and indicated it will likely continue for some time.
Leucovorin for Colorectal Cancer
In an April 1, 2011 report, Kate Murphy of Fight Colorectal Cancer.org noted, "[m]ost of the medicines with shortages are necessary for emergency care, sedation, or chemotherapy — including leucovorin which is a backbone of most colorectal cancer treatment regimens.”
Topic: SPPI - Spectrum Pharmaceuticals, Inc. - NASDAQ (Read 7011 times)
