FDA Approvals: Clobex and Tarceva/Gemzar

Yael Waknine

November 10, 2005

Nov. 10, 2005 -- The U.S. Food and Drug Administration (FDA) has approved clobetasol propionate 0.05% spray for the treatment of moderate to severe plaque psoriasis affecting up to 20% of body surface area in patients aged 18 years and older; and erlotinib plus gemcitabine HCl combination therapy for the first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer.

Clobetasol Propionate 0.05% Spray (Clobex) for Moderate to Severe Plaque Psoriasis

On Oct. 27, the FDA approved clobetasol propionate 0.05% spray (Clobex, made by Galderma Laboratories, LP) for the treatment of moderate to severe plaque psoriasis affecting up to 20% of body surface area (BSA) in patients aged 18 years and older.

The approval was based on data from two identically designed clinical trials in 209 adult patients (median baseline BSA, 6%) who were randomized to receive clobetasol or placebo spray twice daily for up to four weeks.

In the first study, clear or almost clear ratings were achieved by 55% of clobetasol-treated patients at two weeks (vs placebo, 2%), and 78% of patients at four weeks (vs placebo, 3%). The second study yielded similar results (week 2, 47% vs 0%; week 4, 82% vs 2%).

The most commonly reported adverse events occurred with similar frequency in both groups and included burning, pruritus, dryness, pain, hyperpigmentation, irritation, and atrophy at the treatment site.

Potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis due to systemic absorption of clobetasol was evaluated in two studies of patients with psoriasis-affected BSA of 20% or greater. Results showed that rates of HPA suppression were comparable after two and four weeks of twice-daily treatment with clobetasol spray (19% and 15%-20%, respectively); the condition was transient and resolved in all patients upon discontinuation of therapy.

To reduce the risk of HPA suppression, treatment with clobetasol spray should be limited to the minimum period necessary to achieve desired results, not to exceed four weeks' duration or a total weekly dose of 50 g (59 mL or 2 fl oz).

Erlotinib (Tarceva) Plus Gemcitabine (Gemzar) for First-Line Treatment of Pancreatic Cancer

On Nov. 2, the FDA approved a new indication for erlotinib (Tarceva tablets, made by OSI Pharmaceuticals, Inc.), allowing its use in combination with gemcitabine HCl (Gemzar injection, made by Eli Lilly & Co.) for the first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer.

The approval was based on data from a randomized, double-blind, phase 3 clinical study in 569 patients. The study results showed that the combination treatment was associated with a 12.8-day mean increase in overall survival compared with gemcitabine alone (6.4 vs 6.0 months; hazard ratio [HR], 0.81; P = .028).

The addition of erlotinib was also associated with a significant increase in one-year survival (23.8% vs 19.4%) and progression-free survival (3.8 vs 3.5 months; HR, 0.76; P = .006) compared with gemcitabine monotherapy.

Although no differences were observed in tumor response (8.6% vs 7.9%; P = .087), erlotinib/gemcitabine therapy yielded a significantly increased rate of disease control compared with gemcitabine alone (59% vs 49%; P = .036).

The most frequently reported adverse events in patients receiving erlotinib plus gemcitabine included fatigue,rash, nausea, anorexia, and diarrhea. Rash and diarrhea were more common among patients receiving combination therapy compared with gemcitabine alone (69% vs 30% for rash and 48% vs 30% for diarrhea).

Erlotinib/gemcitabine therapy for pancreatic cancer is currently under review for approval by the European Commission.

Erlotinib was previously approved by the FDA as monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

Gemcitabine was previously approved for use as monotherapy for locally advanced or metastatic pancreatic adenocarcinoma. It is also approved for use in combination with paclitaxel for the first-line treatment of anthracycline-resistant metastatic breast cancer, and with cisplatin for the first-line treatment of inoperable, locally advanced, or metastatic NSCLC.

Reviewed by Gary D. Vogin, MD

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