User login
[UPDATE: 5:04 pm] Alectinib has been approved by the Food and Drug Administration for the treatment of patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who have been treated unsuccessfully with crizotinib.
Alectinib was approved based on data from two single-arm clinical trials of patients with crizotinib-refractory metastatic ALK-positive NSCLC.
One study, conducted in North America, included 87 patients who were treated with 600 mg of oral alectinib twice daily. A total of 38% of patients experienced a reduction in tumor size with a 7.5-month duration of response. In the second trial with the same treatment regimen, conducted globally, 44% of patients saw a reduction in tumor size with an 11.2-month duration of response.
Treatment with alectinib also reduced the size of brain metastases in 61% of patients in a pooled subset of patients in both trials, with a 9.1-month duration of response.
The most common adverse events were fatigue, constipation, edema, and myalgias.
“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with [crizotinib],” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, said in a written statement. “In addition to the primary effect on tumors in the lung, [alectinib] clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand.”
Alectinib will be marketed as Alecensa by Genentech. It was approved under several FDA accelerated approval programs. Treatment with alectinib is expected to cost approximately $12,500 per month, according to a Genentech spokesperson.*
On Twitter @denisefulton
*This story has been updated with cost information.
*Correction, 12/21/2015: An earlier version of this story misspelled metastatic.
[UPDATE: 5:04 pm] Alectinib has been approved by the Food and Drug Administration for the treatment of patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who have been treated unsuccessfully with crizotinib.
Alectinib was approved based on data from two single-arm clinical trials of patients with crizotinib-refractory metastatic ALK-positive NSCLC.
One study, conducted in North America, included 87 patients who were treated with 600 mg of oral alectinib twice daily. A total of 38% of patients experienced a reduction in tumor size with a 7.5-month duration of response. In the second trial with the same treatment regimen, conducted globally, 44% of patients saw a reduction in tumor size with an 11.2-month duration of response.
Treatment with alectinib also reduced the size of brain metastases in 61% of patients in a pooled subset of patients in both trials, with a 9.1-month duration of response.
The most common adverse events were fatigue, constipation, edema, and myalgias.
“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with [crizotinib],” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, said in a written statement. “In addition to the primary effect on tumors in the lung, [alectinib] clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand.”
Alectinib will be marketed as Alecensa by Genentech. It was approved under several FDA accelerated approval programs. Treatment with alectinib is expected to cost approximately $12,500 per month, according to a Genentech spokesperson.*
On Twitter @denisefulton
*This story has been updated with cost information.
*Correction, 12/21/2015: An earlier version of this story misspelled metastatic.
[UPDATE: 5:04 pm] Alectinib has been approved by the Food and Drug Administration for the treatment of patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who have been treated unsuccessfully with crizotinib.
Alectinib was approved based on data from two single-arm clinical trials of patients with crizotinib-refractory metastatic ALK-positive NSCLC.
One study, conducted in North America, included 87 patients who were treated with 600 mg of oral alectinib twice daily. A total of 38% of patients experienced a reduction in tumor size with a 7.5-month duration of response. In the second trial with the same treatment regimen, conducted globally, 44% of patients saw a reduction in tumor size with an 11.2-month duration of response.
Treatment with alectinib also reduced the size of brain metastases in 61% of patients in a pooled subset of patients in both trials, with a 9.1-month duration of response.
The most common adverse events were fatigue, constipation, edema, and myalgias.
“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with [crizotinib],” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, said in a written statement. “In addition to the primary effect on tumors in the lung, [alectinib] clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand.”
Alectinib will be marketed as Alecensa by Genentech. It was approved under several FDA accelerated approval programs. Treatment with alectinib is expected to cost approximately $12,500 per month, according to a Genentech spokesperson.*
On Twitter @denisefulton
*This story has been updated with cost information.
*Correction, 12/21/2015: An earlier version of this story misspelled metastatic.
