FDA Approvals: Bexxar, Vfend, and First-Time Generics

Yael Waknine

January 13, 2005

Jan. 13, 2005 — The U.S. Food and Drug Administration (FDA) has approved an expanded indication for tositumomab therapy, allowing its use in a broader population of patients with non-Hodgkin's lymphoma; a new indication for voriconazole injection, tablets, and oral suspension, allowing their use in the treatment of candidemia, deep tissue and other infections caused by Candida; and new generic formulations for halobetasol propionate ointment and cream 0.05%, mometasone furoate cream 0.1%, 1- and 2-mg glycopyrrolate tablets; hydrocortisone butyrate ointment, and ciclopirox cream 0.77%.

Expanded Indication Allows Broader Use of Tositumomab Regimen (Bexxar) in Non-Hodgkin's Lymphoma

On Jan. 3, the FDA approved an expanded indication for the tositumomab plus iodine 131 regimen (Bexxar, made by GlaxoSmithKline), removing the requirement that patients with non-Hodgkin's lymphoma be refractory to rituximab and have relapsed after chemotherapy.

The regimen is now indicated for the treatment of patients with CD20 antigen-expressing relapsed or refractory, low-grade, follicular or transformed non-Hodgkin's lymphoma, including patients with rituximab-refractory non-Hodgkin's lymphoma.

The approval was based on the results of a multicenter, single-group, open-label study involving 60 patients with chemotherapy-refractory patients (median age, 60; median time to diagnosis, 53 months; median prior chemotherapy regimens, 4). The majority of patients (88%) had not responded to prior therapy and 12% had responded for a duration of less than six months.

Treatment with the tositumomab regimen was shown to induce an overall response rate of 47% (95% confidence interval [CI], 34% - 60%), with a median duration of 12 months (range, 2-47 months; 95% CI, 7-47 months).

Complete response was achieved in 20% of patients (95% CI, 11% - 32%), with a median duration of 47 months (range, 9-47 months; 95% CI, 47 months to Not Reached) after a median follow-up of 30 months.

Voriconazole (Vfend) for Candida Blood, Deep Tissue, and Other Infections

On Dec. 21, the FDA approved new indications for voriconazole injection, tablets, and oral suspension (Vfend, made by Pfizer, Inc.), allowing its use in the treatment of candidemia in nonneutropenic patients, and in disseminated skin infections, and abdomen, kidney, bladder wall, and wound infections due to Candida.

The approval was based on data from a randomized, comparative study involving 422 nonneutropenic patients with candidemia and clinical signs of infection. Results showed that voriconazole was similarly effective to amphotericin B (followed by fluconazole) therapy in achieving a successful response, as defined by resolution or improvement of all clinical signs of infection at three months (41% for both). Median treatment time was 15 days.

According to a company news release, treatment with voriconazole cleared candidemia at a rate similar to that for amphotericin B and was associated with a lower incidence of adverse events.

The most frequently reported adverse events (all causalities) included visual disturbances, fever, rash, vomiting, nausea, diarrhea, headache, sepsis, peripheral edema, abdominal pain, and respiratory disorder. Discontinuation of therapy was most commonly due to elevated liver enzyme levels, rash, and visual disturbances.

Voriconazole was previously approved for the treatment of invasive aspergillosis, esophageal candidiasis, and as salvage therapy for fungal infections caused by Scedosporium apiospermum and Fusarium species pathogens.

First-Time Generic Formulations of Ultravate, Elocon, Robinul, Locoid, and Loprox

On Dec. 16, the FDA approved a first-time generic formulation for halobetasol propionate 0.05% ointment (made by Taro Pharmaceuticals USA, Inc., Altana, Inc., and Agis Industries Ltd.; brand name, Ultravate, made by Westwood Squibb) and cream (made by Altana, Inc., and Agis Industries Ltd.; brand name, Ultravate, made by Westwood Squibb).

Halobetasol propionate 0.05% is a super-high-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older.

On Dec. 21, the FDA approved a first-time generic formulation for mometasone furoate cream USP 0.1% (made by Taro Pharmaceuticals USA, Inc.; brand name, Elocon, made by SP Schering Corp.). Mometasone furoate cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged two years and older.

On Dec. 22, the FDA approved first-time generic formulations for 1- and 2-mg glycopyrrolate tablets USP (made by CorePharma, LLC; brand names, Robinul 1-mg and Robinul Forte, made by First Horizon Pharmaceutical Corp.). Glycopyrrolate tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

On Dec. 27, the FDA approved a first-time generic formulation for hydrocortisone butyrate ointment USP 0.1% (made by Taro Pharmaceutical Industries, Inc.; brand name, Locoid, made by Ferndale Laboratories). Hydrocortisone butyrate ointment is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

On Dec. 29, the FDA approved a first-time generic formulation for ciclopirox cream USP 0.77% (made by Altana, Inc.; brand name, Loprox, made by Medicis Pharmaceutical Corp.). Ciclopirox cream is indicated for the treatment of the following dermal infections: tinea pedis, tinea cruris, tinea corporis, candidiasis, and tinea (pityriasis) versicolor.

Reviewed by Gary D. Vogin, MD

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