The announcement of the FDA’s new approval of Fusilev (levoleucovorin) for combined treatment of patients with advanced metastatic colorectal cancer last week has not yet hit the FDA’s online newsroom, but a buzz over stock prices for Spectrum Pharmaceuticals, the company that manufactures the drug, has been all over the Internet.
Last week, the FDA approved Fusilev in combination with 5-fluorouracil for treatment of patients with advanced metastatic colorectal cancer. The drug is a novel isomer used to counteract folic acid antagonists. According to the FDA’s new ruling, the drug can also be marketed in a ready-to-use solution for injection, in addition to the freeze-dried powder formulation that has been on the market and requires reconstitution.
Market interest in Spectrum’s product lines has sent the company’s stock on a roller-coaster ride. The day prior to the FDA’s April 29 decision, the stock flash-crashed in trading on the Nasdaq, plummeting before rising to a 52-week high of $10.63. On the day of the approval, shares rose as much as 14%; the stock closed at $8.58 yesterday.
This week, the company announced record-breaking first-quarter profit of $13 million based on $44 million in revenues, a 4-fold increase in revenue over the same quarter last year.
Speculators are keeping an eye on Spectrum. The company also markets ibritumomab tiuxetan (Zevalin) for relapsed or refractory, low-grade or follicular B-cell non-Hodgkin lymphoma.
Another drug in the company’s pipeline, belinostat, is being tested in a pivotal phase II trial for patients with relapsed/refractory peripheral T-cell lymphoma. Enrollment has completed with data anticipated at American Society of Clinical Oncology (ASCO) annual meeting in June, possibly followed by a new drug application in late 2011 to early 2012.
Data regarding Spectrum’s apaziquone may also be announced at ASCO. Apaziquone, currently being tested in 2 pivotal phase III trials, is operating under a special protocol assessment with the FDA for noninvasive bladder cancer.
Fusilev, which the company said accounted for $35 million of its first-quarter revenues, was approved in 2008 as rescue therapy for patients treated with high-dose methotrexate in osteosarcoma. It also is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
In recent weeks, Fusilev has been used off-label during the leucovorin shortage. According to the FDA ‘s listing of current drug shortages, leucovorin and levoleucovorin are still in short supply.
According to the American Society of Health-System Pharmacists (ASHP), Spectrum Pharmaceuticals already has Fusilev on back order, and the company cannot estimate a release date. The company has supplies of imported levoleucovorin available through wholesalers.
ASHP also highlights implications for patient care and safety concerns of leucovorin and levoleucovorin, as well as related drug shortages on its Web site (http://tiny.cc/amqhz
Fight Colorectal Cancer, an advocacy group, has expressed concerns over pricing. Director of Research Kate M. Murphy recently posted an announcement of the Fusilev indication on the foundation’s Web site (http://fightcolorectalcancer.org/
), noting that the proprietary Fusilev is much more expensive than generic leucovorin, and that Medicare and some insurers have been paying only a part of that cost up until now.
“Medicare reimburses oncology practices $750 for a dose of Fusilev, with the full cost of up to $1200 being absorbed by the practice during the leucovorin shortage,” she wrote. “With FDA approval for the metastatic colorectal cancer indication, Medicare can now reimburse the full cost.”
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