KENILWORTH, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Schering-Plough Corp. (NYSE: SGP) announced today the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company’s supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.
Schering-Plough will work closely with FDA to respond to outstanding concerns related to the PEGINTRON melanoma filing.
In early October, the FDA’s Oncologic Drugs Advisory Committee recommended approval of PEGINTRON in this indication by a vote of 6 to 4. Schering-Plough had sought approval for this indication based on data from the largest positive adjuvant trial in subjects with stage III melanoma.
Introducing new drugs to treat malignant melanoma remains a challenge, and Schering-Plough is committed to the treatment of this aggressive form of cancer.
Full U.S. prescribing information may be found at. http://www.spfiles.com/pipeg-intron.pdf
U.S. Indications for PEGINTRON
PEGINTRON is indicated in the U.S. for use in combination with REBETOL® (ribavirin) for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease.
The following points should be considered when initiating therapy with PEGINTRON in combination with REBETOL: (1) These indications are based on achieving undetectable HCV RNA after treatment for 24 or 48 weeks and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. (2) Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection. (3) No safety and efficacy data are available for treatment of longer than one year.
PEGINTRON is also indicated in the U.S. for use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years of age.
The following points should be considered when initiating therapy with PEGINTRON alone: Combination therapy with REBETOL is preferred over PEGINTRON monotherapy unless there are contraindications to, or significant intolerance of, REBETOL. Combination therapy provides substantially better response rates than monotherapy.
Important U.S. Safety Information on PEGINTRON
WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
