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The kinase inhibitor crizotinib has received full approval for the treatment of metastatic non–small cell lung cancer, based on a study that found treatment with the drug was associated with superior progression-free survival and overall response rates compared with chemotherapy.
The Food and Drug Administration announced the approval Nov. 21 in a written statement.
In August 2011, crizotinib received accelerated approval for the treatment of metastatic non–small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase (ALK) positive, as detected by a test approved by the FDA at the same time. The drug approval was based on objective response rates of 50% and 61% in two single-arm open-label trials; full approval was contingent on providing evidence that confirmed the clinical benefits.
This evidence was provided by an open-label, multinational randomized study of 347 patients with ALK-positive metastatic NSCLC, who had progressed after treatment with platinum-based chemotherapy. The patients were randomized to treatment with crizotinib or chemotherapy, according to the statement. Those who received chemotherapy received pemetrexed or docetaxel if they previously had been treated with pemetrexed.
The median progression-free survival was 7.7 months among those on crizotinib, compared with 3.0 months among those on chemotherapy, a statistically significant difference that represented a reduced risk of 51% (hazard ratio = 0.49). The objective response rate was 65% among those on crizotinib, compared with 20% of those on chemotherapy, also a significant difference. The median response durations were 7.4 months and 5.6 months, respectively. In a planned interim analysis, however, overall survival was the same in both groups, according to the FDA.
Common adverse events associated with crizotinib, affecting at least 25% of treated patients, included nausea, diarrhea, vomiting, visual disorders, constipation, edema, elevated transaminase levels, and fatigue.
In a safety evaluation of 172 patients treated with crizotinib in the study, 37% had serious adverse events, the FDA said. Pneumonia, pulmonary embolism, dyspnea, and interstitial lung disease were the most common. Adverse events, which included acute respiratory distress syndrome, arrhythmia, dyspnea, pneumonia, pneumonitis, pulmonary embolism, interstitial lung disease, respiratory failure, and sepsis, were fatal in nine patients.
Crizotinib is marketed as Xalkori, by Pfizer. It comes in a capsule formulation and is administered at a dose of 250 mg, twice a day, with or without food.
The prescribing information is available here.
Serious adverse events associated with crizotinib should be reported to the FDA’s MedWatch program at 800-332-1088 or here.
The kinase inhibitor crizotinib has received full approval for the treatment of metastatic non–small cell lung cancer, based on a study that found treatment with the drug was associated with superior progression-free survival and overall response rates compared with chemotherapy.
The Food and Drug Administration announced the approval Nov. 21 in a written statement.
In August 2011, crizotinib received accelerated approval for the treatment of metastatic non–small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase (ALK) positive, as detected by a test approved by the FDA at the same time. The drug approval was based on objective response rates of 50% and 61% in two single-arm open-label trials; full approval was contingent on providing evidence that confirmed the clinical benefits.
This evidence was provided by an open-label, multinational randomized study of 347 patients with ALK-positive metastatic NSCLC, who had progressed after treatment with platinum-based chemotherapy. The patients were randomized to treatment with crizotinib or chemotherapy, according to the statement. Those who received chemotherapy received pemetrexed or docetaxel if they previously had been treated with pemetrexed.
The median progression-free survival was 7.7 months among those on crizotinib, compared with 3.0 months among those on chemotherapy, a statistically significant difference that represented a reduced risk of 51% (hazard ratio = 0.49). The objective response rate was 65% among those on crizotinib, compared with 20% of those on chemotherapy, also a significant difference. The median response durations were 7.4 months and 5.6 months, respectively. In a planned interim analysis, however, overall survival was the same in both groups, according to the FDA.
Common adverse events associated with crizotinib, affecting at least 25% of treated patients, included nausea, diarrhea, vomiting, visual disorders, constipation, edema, elevated transaminase levels, and fatigue.
In a safety evaluation of 172 patients treated with crizotinib in the study, 37% had serious adverse events, the FDA said. Pneumonia, pulmonary embolism, dyspnea, and interstitial lung disease were the most common. Adverse events, which included acute respiratory distress syndrome, arrhythmia, dyspnea, pneumonia, pneumonitis, pulmonary embolism, interstitial lung disease, respiratory failure, and sepsis, were fatal in nine patients.
Crizotinib is marketed as Xalkori, by Pfizer. It comes in a capsule formulation and is administered at a dose of 250 mg, twice a day, with or without food.
The prescribing information is available here.
Serious adverse events associated with crizotinib should be reported to the FDA’s MedWatch program at 800-332-1088 or here.
The kinase inhibitor crizotinib has received full approval for the treatment of metastatic non–small cell lung cancer, based on a study that found treatment with the drug was associated with superior progression-free survival and overall response rates compared with chemotherapy.
The Food and Drug Administration announced the approval Nov. 21 in a written statement.
In August 2011, crizotinib received accelerated approval for the treatment of metastatic non–small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase (ALK) positive, as detected by a test approved by the FDA at the same time. The drug approval was based on objective response rates of 50% and 61% in two single-arm open-label trials; full approval was contingent on providing evidence that confirmed the clinical benefits.
This evidence was provided by an open-label, multinational randomized study of 347 patients with ALK-positive metastatic NSCLC, who had progressed after treatment with platinum-based chemotherapy. The patients were randomized to treatment with crizotinib or chemotherapy, according to the statement. Those who received chemotherapy received pemetrexed or docetaxel if they previously had been treated with pemetrexed.
The median progression-free survival was 7.7 months among those on crizotinib, compared with 3.0 months among those on chemotherapy, a statistically significant difference that represented a reduced risk of 51% (hazard ratio = 0.49). The objective response rate was 65% among those on crizotinib, compared with 20% of those on chemotherapy, also a significant difference. The median response durations were 7.4 months and 5.6 months, respectively. In a planned interim analysis, however, overall survival was the same in both groups, according to the FDA.
Common adverse events associated with crizotinib, affecting at least 25% of treated patients, included nausea, diarrhea, vomiting, visual disorders, constipation, edema, elevated transaminase levels, and fatigue.
In a safety evaluation of 172 patients treated with crizotinib in the study, 37% had serious adverse events, the FDA said. Pneumonia, pulmonary embolism, dyspnea, and interstitial lung disease were the most common. Adverse events, which included acute respiratory distress syndrome, arrhythmia, dyspnea, pneumonia, pneumonitis, pulmonary embolism, interstitial lung disease, respiratory failure, and sepsis, were fatal in nine patients.
Crizotinib is marketed as Xalkori, by Pfizer. It comes in a capsule formulation and is administered at a dose of 250 mg, twice a day, with or without food.
The prescribing information is available here.
Serious adverse events associated with crizotinib should be reported to the FDA’s MedWatch program at 800-332-1088 or here.
