FDA Approves New Pfizer Cancer Drug

The U.S. Food and Drug Administration approved Sutent (sunitinib) by Pfizer on Jan. 26 for the treatment of patients with gastrointestinal stromal tumors and advanced kidney cancer. It is the first time the FDA has approved a new oncology product for two indications simultaneously, according to an FDA news release.

Sutent received priority review and was approved in less than six months. It is a tyrosine kinase inhibitor working through multiple targets to deprive tumor cells of blood and nutrients needed for growth.

About 32,000 new cases of advanced kidney cancer and 5,000 cases of gastrointestinal stromal tumors are diagnosed every year. About 1,700 patients not involved in clinical trials are now being treated with Sutent though an expanded access program.

The most common side effects associated with Sutent include diarrhea, skin discoloration, mouth irritation, weakness and altered taste. Some patients treated with Sutent also experienced high blood pressure, fatigue, bleeding and swelling.

New Prescription Acne Drug Is Now Available

Benziq (benzoyl peroxide) Gel and Wash by Chester Valley Pharmaceuticals is available for patients with acne. It is the only prescription benzoyl peroxide that is formulated in a unique hydrating complex, according to a company press release.

Dry, flaky skin caused about 65% of patients to interrupt or stop their treatment with benzoyl peroxide, according to one national survey of 307 acne patients between the ages of 14 and 40. Chester Valley Pharmaceuticals created this formulation of benzoyl peroxide to help minimize noncompliance in acne patients caused by dry, flaky skin. Benziq soothes skin irritation as it clears acne lesions.

The ingredients of Benziq's hydrating complex include the powerful humectant hyaluronic acid, along with panthenol and glycerin.

Good compliance is important for the success of acne treatment regimens, and patients who use a less irritating medication are more likely to adhere to a prescribed regimen, according to the survey of acne patients.

Three Benziq acne products are available. Benziq Wash (benzoyl peroxide 5.25%) is gentle and cleansing. Benziq Gel (benzoyl peroxide 5.25%) is appropriate for most patients. Benziq LS Gel (benzoyl peroxide 2.75%) is a low-strength formulation.

Allergic contact dermatitis and dryness have been reported with benzoyl peroxide therapy.

Injectable Drug Approved for Osteoporosis

Boniva (ibandronate) Injection by Roche and GlaxoSmithKline received approval from the U.S. Food and Drug Administration on Jan. 6 for the treatment of postmenopausal osteoporosis. Boniva Injection, which was to be available in early 2006, is the first intravenous medication and the first quarterly treatment for the treatment of postmenopausal osteoporosis.

Boniva Injection is administered as a 15- to 30-second IV injection and provides an alternative for patients who have difficulty with oral bisphosphonate dosing requirements, including an inability to sit upright for 30 to 60 minutes or the inability to swallow a pill. Because Boniva Injection must be administered by a health care provider, it will result in greater awareness of patient compliance with osteoporosis treatment regimens, according to the companies.

The FDA approved Boniva Injection based on the results of the DIVA (Dosing IntraVenous Administration) study, which involved 1,358 women with postmenopausal osteoporosis.

Boniva Injection is contraindicated in patients with uncorrected hypocalcemia or known hypersensitivity to Boniva. Patients must receive supplemental calcium and vitamin D.

Boniva Injection 3 mg/3 mL will be available in boxes containing one single-use, clear glass prefilled syringe, along with one needle and one alcohol swab.

New Glycolic Peel System Introduced

Dermatologic Cosmetic Laboratories has introduced the Epi-Peel System, a new glycolic peel system specifically developed to offer health care professionals a more efficient and effective method to administer professional in-office glycolic peels.

The Epi-Peel System is available in two formulations: Level 1 (40% active) and Level II (70% active). The Level I formulation introduces a clinically active level of willowherb extract, which is intended to help soothe and calm the skin while the beneficial effects of the peel are taking effect. The formula has a gel-like consistency designed for easier spreading and even application, according to a company news release.

The Level II formulation includes the most effective topical antioxidant, vitamin C.

Each system comes in a convenient 50-application kit, which includes the glycolic peel solution, a dose-controlling measuring cup, special cotton applicators and simple three-step instructions for administering the peel.

Skin Treatment Available from ProCyte

Neova Retinol ME by ProCyte is ideal for skin damaged by sun exposure and showing signs of fine wrinkling, mottling and uneven skin texture, according to a company press release.

Neova Retinol ME uses a microencapsulated delivery system to help refine skin tone and texture without unnecessary irritation, according to the release.