The approval of Schering-Plough Corp’s (SGP) melanoma drug Pegintron was recently recommended by the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA). The advisory committee voted six to four in favor of the approval of the injectable drug for melanoma patients undergoing surgery for skin cancer. The drug is approved as a treatment for hepatitis C.
Even though the FDA is not bound to accept the recommendations of the advisory committee, it usually does so. The supplemental Biologics License Application (sBLA) for the cancer indication was filed by Schering in September 2007.
Pegintron, a longer-acting form of the protein interferon alfa-2b, won the narrow backing of the panel despite results showing that it did not extend patients’ lives. However, the fact that it lengthened the time period before cancer recurred by about nine months worked in its favor.
Consequently, it got a favorable recommendation as the majority of the panelists felt that the potential benefits of the drug outweighed its toxic risks as a treatment for late-stage skin cancer.
Schering-Plough already markets another interferon drug Intron A, for treating recurring skin cancer after surgery. The approval of Pegintron for skin cancer would increase the options available to patients for treating the deadliest form of skin cancer.
We note that Schering-Plough is currently gearing up for the $41.1 billion merger with Merck & Co. (MRK), which is expected to close by year-end. The merger should enable the combined entity to become one of the top five drugmakers in the world as top selling products of both companies will come under one roof.
Currently, we are Neutral on Schering-Plough.
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