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Approval of Sylatron (peginterferon alfa-2b) by FDA
Brand Name: Sylatron
Generic Name: peginterferon alfa-2b
Company Name: Merck
Date of Approval: March 29, 2011
Treatmant for: Malignant Melanoma
Merck (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) has approved Sylatron (peginterferon alfa-2b) for injection, for subcutaneous use. Sylatron is indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. Sylatron is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, in patients with autoimmune hepatitis, and in patients with hepatic decompensation (Child-Pugh score >6 [class B and C]).

"Merck is pleased to offer patients with node-positive melanoma this new option to treat the disease," said Eric Rubin, M.D., vice president of clinical oncology at Merck. "This is the first such therapy approved for the adjuvant treatment of melanoma by the FDA in more than 15 years. Merck remains committed to further innovative research to help people suffering from cancer."

The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons, including Sylatron. Sylatron should be permanently discontinued in patients with persistently severe or worsening signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not resolve after stopping Sylatron.

Sylatron is a once-weekly subcutaneous injection that may be self-injected. The recommended dose is 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years. Patients should be premedicated with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of Sylatron and as needed for subsequent doses.

The Prescribing Information for Sylatron recommends the following dose modifications that are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 2.0):
  • Sylatron should be permanently discontinued for: persistent or worsening severe neuropsychiatric disorders; grade 4 non-hematologic toxicity; inability to tolerate a dose of 1 mcg/kg/week; new or worsening retinopathy.

  • Sylatron should be withheld for any of the following: absolute Neutrophil Count (ANC) <0.5x109/L; platelet Count (PLT) <50x109/L; ECOG PS =2; non-hematologic toxicity = Grade 3.

  • Sylatron should be resumed at a reduced dose (see Table 1 below) when all of the following are present: absolute Neutrophil Count (ANC) =0.5x109/L; platelet Count (PLT) =50x109/L; ECOG PS 0-1; non-hematologic toxicity has completely resolved or improved to Grade 1.

Clinical Trial Results

The approval of Sylatron is based on data from the European Organisation for the Research and Treatment of Cancer (EORTC) clinical trial, a large trial conducted in patients with node-positive melanoma, titled "Adjuvant Therapy with Pegylated Interferon Alfa-2b versus Observation in Resected Stage III Melanoma," which was published in the July 2008 issue of The Lancet.

The clinical trial was an open-label, multi-center, randomized study that evaluated the safety and efficacy of Sylatron in 1,256 patients with surgically resected, AJCC Stage III melanoma within 84 days of regional lymph node dissection. Patients were randomized to observation (no therapy) (n=629) or to Sylatron (n=627) at a dose of 6 mcg/kg by subcutaneous injection once weekly for 8 doses followed by a 3 mcg/kg subcutaneous injection once weekly for a period of up to 5 years total treatment. The dose of Sylatron was adjusted to maintain an ECOG Performance Status of 0 to 1.

In the study, ninety-four patients (16 percent) did not continue on to the 3 mcg/kg/week dosing regimen. Patients who continued on Sylatron after the initial 8 doses received 3 mcg/kg/week for a median duration of treatment of 14.3 months. Approximately half (52 percent) of the patients underwent dose reductions and 70 percent required dose delays (average delay 2.2 weeks).

The study's primary endpoint was Relapse-Free Survival (RFS), defined as the time from randomization to the earliest date of any relapse (local, regional, in-transit, or distant), or death from any cause. Based on 696 RFS events determined by the Independent Review Committee, the estimated hazard ratio (HR) for RFS was 0.82 (95 percent CI: 0.71, 0.96; unstratified log-rank p=0.011) in favor of patients treated with Sylatron. The median RFS was 34.8 months (95 percent CI: 26.1, 47.4) and 25.5 months (95 percent CI: 19.6, 30.8) in the patients treated with Sylatron compared with the patients in the observation group, respectively.

In the study, the most common adverse reactions with Sylatron versus observation were fatigue (94 percent versus 41 percent), increased ALT (77 percent versus 26 percent), increased AST (77 percent versus 26 percent), pyrexia (fever) (75 percent versus 9 percent), headache (70 percent versus 19 percent), anorexia (69 percent versus 13 percent), myalgia (muscle pain) (68 percent versus 23 percent), nausea (64 percent versus 11 percent), chills (63 percent versus 6 percent) and injection site reaction (62 percent versus 0 percent).

The most common serious adverse reactions were fatigue (7 percent), increased ALT (3 percent), increased AST (3 percent), and pyrexia (3 percent) in the group treated with Sylatron versus <1 percent in the observation group for these reactions.

Thirty-three percent of patients receiving Sylatron discontinued treatment due to adverse reactions.

Secondary endpoints of the study included Overall Survival (OS). There was no statistically significant difference in survival between Sylatron and the observation arms. Based on 525 deaths, the estimated hazard ratio of Sylatron versus observation was 0.98 (95 percent CI: 0.82, 1.16).
Note: To know more please go to the following sources.
Update: 2011-04-02
Source: & FDA
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