April 4, 2011 — On March 29, the US Food and Drug Administration (FDA) approved peginterferon alfa-2b (Sylatron, Schering Corporation) to treat melanoma with nodal involvement after surgical resection. In a clinical trial, patients who took the drug delayed cancer recurrence by about 9 additional months compared with patients who did not take the drug.
Peginterferon alfa-2b treatment can begin within 84 days of lymphadenectomy and other definitive surgical resections to treat microscopic or gross nodal involvement.
The drug's approval was based on a 5-year, open-label, multicenter clinical trial of 1256 patients with melanoma (EORTC 18991). The data were reviewed by an independent blinded committee.
In the trial, patients were randomly assigned to receive peginterferon alfa-2b or to be observed. They were assessed for metastases every 3 months for the first 2 years, and every 6 months for the remaining years. The efficacy endpoint of the trial was relapse-free survival (RFS), which the FDA stated was "the time to the earliest of local or regional recurrence, distant metastases, or death."
Of the 696 patients who did relapse, those who took peginterferon alfa-2b had an estimated median RFS of 34.8 months (95% confidence interval [CI], 26.1 - 47.4). Patients who not take peginterferon alfa-2b had an estimated median RFS of 25.5 months (95% CI, 19.6 - 30.8).
Peginterferon alfa-2b did not affect overall survival between the 2 groups of patients (hazard ratio, 0.98; 95% CI, 0.82 - 1.16). By the end of the 5-year trial period, 525 patients had died.
The recommended peginterferon alfa-2b treatment, which can extend up to 5 years, is 6 μg/kg/week subcutaneously for 8 weeks, then 3 subcutaneous μg/kg/week for the remainder of the time.
The FDA reported that one third of patients receiving peginterferon alfa-2b stopped taking the medication because of adverse effects. More than 60% of patients who took peginterferon alfa-2b had fatigue, increased alanine aminotransferase and aspartate aminotransferase levels, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reactions.
Five patients receiving peginterferon alfa-2b died within 30 days of stopping the medication, 2 of them from cardiovascular disease. The FDA stated that these 2 deaths might be related to peginterferon alfa-2b use.
Sylatron is the second melanoma drug, and the third oncology drug, approved by the FDA in 2011. On March 25, the agency approved Bristol-Meyers Squibb's Yervoy (ipilimumab injection) to treat metastatic or unresectable melanoma.
Alpha interferons such as Sylatron increase the risk for neuropsychiatric disorders such as serious depression. Full prescribing instructions and clinical trial information are available from the FDA's Web site.
Peginterferon alfa-2b treatment can begin within 84 days of lymphadenectomy and other definitive surgical resections to treat microscopic or gross nodal involvement.
The drug's approval was based on a 5-year, open-label, multicenter clinical trial of 1256 patients with melanoma (EORTC 18991). The data were reviewed by an independent blinded committee.
In the trial, patients were randomly assigned to receive peginterferon alfa-2b or to be observed. They were assessed for metastases every 3 months for the first 2 years, and every 6 months for the remaining years. The efficacy endpoint of the trial was relapse-free survival (RFS), which the FDA stated was "the time to the earliest of local or regional recurrence, distant metastases, or death."
Of the 696 patients who did relapse, those who took peginterferon alfa-2b had an estimated median RFS of 34.8 months (95% confidence interval [CI], 26.1 - 47.4). Patients who not take peginterferon alfa-2b had an estimated median RFS of 25.5 months (95% CI, 19.6 - 30.8).
Peginterferon alfa-2b did not affect overall survival between the 2 groups of patients (hazard ratio, 0.98; 95% CI, 0.82 - 1.16). By the end of the 5-year trial period, 525 patients had died.
The recommended peginterferon alfa-2b treatment, which can extend up to 5 years, is 6 μg/kg/week subcutaneously for 8 weeks, then 3 subcutaneous μg/kg/week for the remainder of the time.
The FDA reported that one third of patients receiving peginterferon alfa-2b stopped taking the medication because of adverse effects. More than 60% of patients who took peginterferon alfa-2b had fatigue, increased alanine aminotransferase and aspartate aminotransferase levels, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reactions.
Five patients receiving peginterferon alfa-2b died within 30 days of stopping the medication, 2 of them from cardiovascular disease. The FDA stated that these 2 deaths might be related to peginterferon alfa-2b use.
Sylatron is the second melanoma drug, and the third oncology drug, approved by the FDA in 2011. On March 25, the agency approved Bristol-Meyers Squibb's Yervoy (ipilimumab injection) to treat metastatic or unresectable melanoma.
Alpha interferons such as Sylatron increase the risk for neuropsychiatric disorders such as serious depression. Full prescribing instructions and clinical trial information are available from the FDA's Web site.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου