FDA geeft 3M-pharmaceuticals toestemming om Aldarazalf -Imiquimod als medicijn tegen niet-melanome huidkankers te gebruiken

16 juli 2004: Bron: DOW-news

Ook de FDA - Federal Drugs Adminstration - geeft per juli 2004 3M Pharmaceuticals toestemming om Aldara zalf te gebruiken in Amerika bij niet melanome huidkankers - basecellcancer. Wel geven ze een restrictie aan dat de zalf alleen bij moeilijk of niet operabele patiënten mag worden gebruikt. Chirurgie is voor de FDA nog steeds eerstelijns en eerste optie voor niet-melanome huidkankers - basecellcancer. Maar deze zalf lijkt een uitstekend alternatief c.q. aanvulling voor bepaalde stadia van niet- melanome huidkankers.
Ook in Nederland worden niet-melanome huidkankers vaak met PDT - photodynamische Therapy = met licht - laser behandeld.

Hier het originele persbericht over toestemming voor Aldarazalf bij ons binnengekomen via DOWnews. Met dank aan de man die ons steeds deze berichtgevingen via DOWnews toestuurt.

- =DJ FDA Approves 3M's Aldara Cream For Skin Cancer -- WASHINGTON (Dow Jones)--The Food and Drug Administration approved a topical cream Thursday for the treatment of a certain type of skin cancer. The cream, Aldara, is made by 3M Pharmaceuticals, a unit of Maplewood, Minn.-based 3M (MMM). The product is already approved for the treatment of actinic keratosis, a precancerous skin condition, and external genital warts. The FDA approval will allow Aldara to be used for the treatment of superficial basal cell carcinoma, or sBCC. The FDA is recommending that physicians use the cream on patients who are not good surgical candidates. The FDA said the chances of treating superficial basal cell cancer are better with surgery. Basel cell carcinoma, the most common type of skin cancer, affects about 800,000 Americans each year. There are four types of basal cell carcinomas - superficial, nodular, pigmented, ulcerating, or sclerosing types. Superficial cancer typically occurs on the arms, legs, back and chest. Aldara is not approved for use on the face or for tumors larger then two centimeters. "Skin cancer is one of the most prevalent forms of cancer," said Lester M. Crawford, acting FDA commissioner. "Today's approval provides another example of FDA's commitment to bringing new cancer therapies to the market." The FDA said patients treated with Aldara should have regular follow-up visits after treatment to make sure the skin cancer is completely treated. The agency said the safety and effectiveness of Aldara were established in two double-blind controlled studies with approximately 364 patients. In these studies, 75% of patients who had sBCC treated with Aldara had no evidence of the disease 12 weeks after finishing treatment. In a separate long-term study involving 182 patients, 79% of patients had no evidence of sBCC two years after finishing treatment. Most people using Aldara Cream for the treatment of sBCC experienced skin reactions at the treatment site, including redness, swelling, a sore or blister, peeling, itching, and burning. -By Jennifer Corbett Dooren, Dow Jones Newswires;

huidkanker, Imiquimod