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These drugs were recently approved by the FDA:
• New indication for imiquimod (Aldara) topical cream by 3M Pharmaceuticals. The FDA has approved imiquimod (Aldara) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer. Imiquimod had previously been approved for the treatment of actinic keratosis and external genital warts. SBCC is diagnosed by a health care provider after biopsy and is different from other types of skin cancer, including other types of basal cell carcinoma. It usually is treated by surgical removal.
Imiquimod should be used for treatment of sBCC only when surgery is medically less appropriate, because the chances of effectively treating sBCC are generally greater with surgery. Patients treated with imiquimod for sBCC should have regular follow-up visits after treatment to make sure the skin cancer is completely treated.
The safety and effectiveness of imiquimod were established in two double-blind controlled studies with approximately 364 patients. In these studies, 75% of patients (139/185) who had their sBCC treated with imiquimod had no evidence clinically or on repeat biopsy of their sBCC at 12 weeks after finishing treatment. In a separate long-term study involving 182 patients, 79% of patients had no evidence of their sBCC at two years after finishing treatment.
The FDA is approving imiquimod for treatment of sBCC on the body, neck, arms, or legs, but not for treatment of sBCC on the face. Most patients using imiquimod cream for the treatment of sBCC experienced skin reactions at the treatment site, which include redness, swelling, a sore or blister, peeling, itching, and burning.
• NeutroSpec (formerly LeuTech) by Mallinckrodt and Palatin Technologies. The FDA has approved NeutroSpec, a new imaging agent developed to help diagnose cases of appendicitis in patients 5 years and older with atypical symptoms.
NeutroSpec enables physicians to rapidly diagnose appendicitis in cases without straightforward symptoms. Ninety percent of the positive appendicitis cases in the NeutroSpec III clinical trial were diagnosed within one hour.
NeutroSpec is a radiolabeled monoclonal antibody — Technetium (99m Tc) fanolesomab. When injected into a patient’s bloodstream, NeutroSpec radiolabels white blood cells and myeloid precursors with a radioactive tracer. This enables a physician to quickly locate the site of infection with images generated by a gamma camera in a hospital’s nuclear medicine department.
No additional equipment to use NeutroSpec is needed and, in most cases, NeutroSpec will be available as a unit-dose injection. The most frequently reported adverse reactions during the Phase III trial were flushing (3.6% of patients) and shortness of breath (1.4% of patients). Unlike other imaging agents, NeutroSpec does not require blood handling.
• Fixed-dose combination treatment of abacavir/lamivudine (Epzicom) and tenofovir disoproxil/emtricitabine (Truvada) by GlaxoSmithKline and Gilead Sciences, respectively. The FDA has approved abacavir/lamivudine (Epzicom) and tenofovir disoproxil/emtricitabine (Truvada) as two fixed-dose combination treatment for HIV-1 infection.
Abacavir/lamivudine and tenofovir disoproxil/ emtricitabine are indicated for use in combination with other antiretroviral drug products from different classes such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors for the treatment of adults with HIV-1 infection.
Epzicom is a fixed-dose combination of the antiretroviral drugs abacavir sulfate 600 mg and lamivudine 300 mg, both of which are approved individually under the brand names abacavir sulfate (Ziagen) and lamivudine (Epivir). Epzicom’s approval is based on a large clinical study that showed that abacavir dosed once daily had a similar antiviral effect as abacavir dosed twice daily both in conjunction with lamivudine and with efaviranz, another antiretroviral drug.
Truvada is a fixed-dose combination of the antiretroviral drugs tenofovir disoproxil fumarate 300 mg (Viread) and emtricitabine 200 mg (Emtriva). The approval of Truvada is based on data demonstrating therapeutic equivalence between the combination product and the individual products. FDA completed its review of Epzicom in 10 months and its review of Truvada in four months.