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The FDA has granted priority review status to the New Drug Application for sorafenib for patients with advanced renal cell carcinoma. Sorafenib is an oral multi-kinase inhibitor—under development by Bayer Pharmaceuticals and Onyx Pharmaceuticals—that targets tumor cell growth and angiogenesis by blocking both the RAF kinase and vascular endothelial growth factor receptor.
The FDA has granted priority review status to the New Drug Application for sorafenib for patients with advanced renal cell carcinoma. Sorafenib is an oral multi-kinase inhibitor-under development by Bayer Pharmaceuticals and Onyx Pharmaceuticals-that targets tumor cell growth and angiogenesis by blocking both the RAF kinase and vascular endothelial growth factor receptor.
The NDA is based on an ongoing phase III study in more than 900 patients with advanced kidney cancer who previously failed one prior systemic therapy. Interim results, presented in May at the American Society of Clinical Oncology's annual meeting, demonstrated that sorafenib doubled patients' median progression-free survival to 24 weeks, compared with placebo, and disease progression was significantly delayed. Thus far, the most common adverse effects found in the 769 patients who have been evaluated for safety were rash, diarrhea, hand-foot syndrome, hair loss, itching, hypertension, nausea, and fatigue.
Sorafenib is currently available to patients through an open-label treatment protocol known as the Advanced Renal Cell Carcinoma Sorafenib study. The companies are also conducting phase III studies evaluating sorafenib in patients with advanced primary liver cancer and metastatic melanoma.
Eisai Medical Research Inc. has submitted an NDA to the FDA seeking approval for rufinamide as adjunctive therapy for Lennox-Gastaut syndrome (LGS) in children four years of age and older and as adjunctive therapy for partial-onset seizures with and without secondary generalization in adults and adolescents aged 12 years or older.
Rufinamide is a triazole derivative that is structurally distinct from currently approved antiepileptic drugs (AEDs). Results from a double-blind, randomized, placebo-controlled trial of rufinamide for the treatment of patients with LGS, a disorder that includes tonic-clonic seizures, atypical absences, and atonic seizures, were presented in April at the 57th annual meeting of the American Academy of Neurology. The seizures associated with LGS are very refractory and difficult to treat despite the availability of many new AEDs. In this study, 42% of 74 patients in the rufinamide group experienced a 50% or more reduction in atonic seizures. Only 16.7% of the placebo group achieved a 50% or more reduction in atonic seizures. For all seizure types, the treatment group as a whole achieved a 32.7% reduction in seizure frequency, compared with an 11.7% drop for the placebo group. In October 2004 the FDA designated rufinamide as an orphan drug for the LGS indication.
In double-blind studies, the most common adverse effects seen in association with rufinamide and at a higher frequency (greater than or equal to 10%) than in placebo-treated patients were headache, dizziness, fatigue, somnolence, and nausea.
Anidulafungin use in invasive candidiasis/candidemia
The incidence of systemic fungal infections that are resistant to treatment continues to rise. These infections often affect patients with compromised immune systems and can be fatal despite current treatments. To address the growing need for new therapies, Vicuron is developing anidulafungin, a novel echinocandin that is part of the family of antifungals that act by inhibiting glucan synthase in the fungal cell wall.
In May 2004, Vicuron received an approvable letter from the FDA for use of anidulafungin in the treatment of esophageal candidiasis and in August 2005, the company filed for approval of the drug in the treatment of invasive candidiasis/candidemia, the most common hospital-acquired fungal infection.
The NDA includes data from a double-blind, randomized trial of more than 250 patients that was designed to study the safety and efficacy of a 100-mg daily dose of anidulafungin, preceded by an initial 200-mg loading dose of anidulafungin, versus fluconazole in invasive candidiasis/candidemia. Patients received daily IV infusions of either anidulafungin or fluconazole for 10 to 42 days.
Anidulafungin was superior to fluconazole in the primary endpoint, global response at the end of intravenous therapy in the microbiological intent-to-treat population. Anidulafungin also demonstrated noninferiority or superiority in all secondary endpoints, including responses at the two-week and six-week follow-up visits after completion of therapy. Anidulafungin was well tolerated in the study, with a side-effect profile comparable to that of fluconazole.