FDA approves PEG-interferon Alfa 2b (Sylatron(tm)), for adjuvant melanoma)

In cooperation with the food and Drug Administration (FDA), and as a service to our members, ASCO provide updates on the recent FDA approvals and other important FDA actions (such as updated security information, new prescription information) with regard to therapies for cancer patients. Thus, the Agency may notify oncologists and specialists in oncology-related fields in a timely manner. Included in the e-Mail of the FDA a link on the product label or to other sites will be additional relevant clinical information. The following is a message from the FDA Office of oncology drug products Director, Dr. Richard Pazdur:

On the 29 March 2011 the U.S. approved administration of PEG-interferon alfa-2 b (Sylatron ™, Schering Corporation, Kenilworth, NJ 07033), for the treatment of patients with malignant melanoma with microscopic or grossly nodal involvement 84 days the final surgical resection including complete Lymphadenectomy food and drug.

Approval based on a single attempt, EORTC 18991, an open-label, multicenter study in 1256 enrolling patients. Patients who was appropriate surgically resected for their primary cutaneous melanoma and concerned regional lymph nodes had been randomized (1: 1), to either Sylatron or observation for a period of 5 years. Stratification factors include type of nodal participation (microscopic versus gross), number of positive nodes (1, 2-4, 5 or more, or unweighted), Breslow primary (less than 1.5 mm thickness, greater than or equal to 1.5-4 mm, greater than or equal to 4 mm), Ulceration of the primary tumor (available or not available or unknown), sex and study centre. Every three months for the first two years of treatment and then every six months to the end of the study were evaluated patients for local and regional recurrence or distant metastases. An independent Review Committee, blinded randomization mapping and information that would break the treatment blind, checks that occur case report form data to, and determine the date of the loco regional recurrence or distant metastasis.

The primary endpoint, survival (RFS), relapse was defined as the time to the earliest of the local or regional recurrence, distant metastases, or death. As a result of 696 RFS events, improving the RFS for Sylatron treated patients [hazard ratio 0.82 (95% CI: 0.71, 0.96);] [Classes log rank p 0.011 =] was observed. The estimated median was RFS 34.8 months (95% CI: 26.1, 47.4) and 25.5 months (95% CI: 19.6, 30.8) in the coat of arms of Sylatron and observation or. After 525 deaths on study, there was no difference between the Sylatron and the observation of arms overall survival [hazard ratio 0.98 (95% CI: 0.82, 1.16)].

Safety was evaluated in 608 Sylatron treated patients in EORTC 18991. The most (> 60%) Grade 1-4 adverse reactions to Sylatron treated patients were experience fatigue, increased ALT, increased AST, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reactions. The most common serious adverse reactions, in Sylatron treated patients were fatigue, increased AST, increased ALT and pyrexia.

33 Percent of patients, the Sylatron discontinued treatment because of side effects. The most common side effects that drop off at the time of the treatment were fatigue, depression, anorexia, increased ALT, increased AST, myalgia, nausea, headache, and pyrexia. Five deaths were reported within 30 days after the last dose of Sylatron from. Two have been recurrent disease, attributed to two to cardiovascular disease related to Sylatron, and after an accident.

The recommended dose and schedule for the Sylatron is followed 6 mcg / kg / week subcutaneously for 8 doses from 3 mcg / kg / week subcutaneously. The maximum treatment is 5 years (260 weeks).

Complete prescribing information, including clinical trial information, safety, dosage, interactions and contraindications is here.

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