Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). This multicenter, non-randomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Avastin. There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment.
Avastin is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with Avastin. Genentech intends to revise the Avastin package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin.
原文：
Genentech, Inc. would like to inform you of important new safety information regarding
AVASTIN® (bevacizumab).This information concerns tracheoesophageal (TE) fistula that occurred in a study combining concurrent chemotherapy and radiation plus AVASTIN in patients with limited-stage small cell lung cancer (SCLC).AVASTIN is not indicated for use in SCLC.
In an investigator-sponsored multicenter, single-arm phase II trial, patients with limited-stage SCLC received four cycles of concurrent irinotecan, carboplatin, radiation therapy, and AVASTIN followed by maintenance AVASTIN for up to 6 months.There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in the study.A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause), was also
reported, in which TE fistula was suspected but not confirmed. All three events occurred during the AVASTIN maintenance phase of the study in the context of persistent esophagitis. As of March 22, 2007, six cases of TE fistula have also been reported in other lung and esophageal cancer studies involving the use of AVASTIN and chemotherapy alone or with concurrent radiation treatment.
There is limited information in the published literature on the background rate of TE fistula in patients with limited-stage SCLC, but is estimated to be <1%.The incidence of TE fistula observed in this trial to date exceeds this rate. Due to the small number of patients treated in the setting of limited-stage SCLC and the non-randomized nature of this trial, it is not possible to distinguish the toxicity observed in this trial from other risk factors for the development of TE fistula, such as intra-thoracic organ sensitivity from chemotherapy and radiotherapy alone. This study has been
closed to further accrual as of March 12, 2007.
A description of cases of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with AVASTIN in clinical studies and post-marketing reports is included in the current US prescribing information (see WARNINGS: Gastrointestinal Perforation).
Genentech intends to revise the AVASTIN package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with AVASTIN.
AVASTIN is currently approved for the first-line and second-line treatment of etastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy, in addition to the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel.
We have enclosed the current AVASTIN package insert for your information. Should you have any questions regarding the use of AVASTIN, please call our Medical Information/Communications Department at 1-800-821-8590.
Healthcare professionals should report any serious adverse events suspected to be associated with the use of AVASTIN to Genentech at 1-888-835-2555. Alternatively, this information may be reported to FDA’s MedWatch reporting system by phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178), online (https://www.accessdata.fda.gov/scripts/medwatch/) or mailed, using the
MedWatch for FDA 3500, to the FDA Medical Products Reporting Program, 5600 Fishers Lane,Rockville, MD 20852-9787.
Avastin is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with Avastin. Genentech intends to revise the Avastin package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin.
原文：
Genentech, Inc. would like to inform you of important new safety information regarding
AVASTIN® (bevacizumab).This information concerns tracheoesophageal (TE) fistula that occurred in a study combining concurrent chemotherapy and radiation plus AVASTIN in patients with limited-stage small cell lung cancer (SCLC).AVASTIN is not indicated for use in SCLC.
In an investigator-sponsored multicenter, single-arm phase II trial, patients with limited-stage SCLC received four cycles of concurrent irinotecan, carboplatin, radiation therapy, and AVASTIN followed by maintenance AVASTIN for up to 6 months.There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in the study.A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause), was also
reported, in which TE fistula was suspected but not confirmed. All three events occurred during the AVASTIN maintenance phase of the study in the context of persistent esophagitis. As of March 22, 2007, six cases of TE fistula have also been reported in other lung and esophageal cancer studies involving the use of AVASTIN and chemotherapy alone or with concurrent radiation treatment.
There is limited information in the published literature on the background rate of TE fistula in patients with limited-stage SCLC, but is estimated to be <1%.The incidence of TE fistula observed in this trial to date exceeds this rate. Due to the small number of patients treated in the setting of limited-stage SCLC and the non-randomized nature of this trial, it is not possible to distinguish the toxicity observed in this trial from other risk factors for the development of TE fistula, such as intra-thoracic organ sensitivity from chemotherapy and radiotherapy alone. This study has been
closed to further accrual as of March 12, 2007.
A description of cases of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with AVASTIN in clinical studies and post-marketing reports is included in the current US prescribing information (see WARNINGS: Gastrointestinal Perforation).
Genentech intends to revise the AVASTIN package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with AVASTIN.
AVASTIN is currently approved for the first-line and second-line treatment of etastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy, in addition to the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel.
We have enclosed the current AVASTIN package insert for your information. Should you have any questions regarding the use of AVASTIN, please call our Medical Information/Communications Department at 1-800-821-8590.
Healthcare professionals should report any serious adverse events suspected to be associated with the use of AVASTIN to Genentech at 1-888-835-2555. Alternatively, this information may be reported to FDA’s MedWatch reporting system by phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178), online (https://www.accessdata.fda.gov/scripts/medwatch/) or mailed, using the
MedWatch for FDA 3500, to the FDA Medical Products Reporting Program, 5600 Fishers Lane,Rockville, MD 20852-9787.
全站熱搜
留言列表
醫藥類 (14)
