Human medicines European public assessment report (EPAR): Alecensa, alectinib, Date of authorisation: 16/02/2017, Revision: 15, Status: Authorised
Alecensa has been shown to be effective in treating ALK-positive NSCLC.
Advanced NSCLC
Two main studies involved a total of 225 patients with advanced ALK-positive NSCLC in whom the disease progressed despite previous treatment with Xalkori (crizotinib), a cancer medicine that also blocks ALK. In both studies, Alecensa was not compared with any other treatment or placebo (a dummy treatment). A complete response to treatment means that the patient has no remaining signs of the cancer, whereas a partial response means that the cancer has shrunk.
In the first study, around 52% of patients given Alecensa (35 out of 67) were considered by the treating doctors to have a complete or partial response to the medicine. In the second study, this figure was 51% (62 out of 122 patients). Response was maintained for an average of months in both studies.
The third study involved 303 patients whose advanced ALK-positive NSCLC had not been treated before. Alecensa was compared with Xalkori. After 1 year of treatment, 68% of patients receiving Alecensa had lived without their disease getting worse compared with 49% of patients receiving Xalkori.
NSCLC that has been removed by surgery and is at high risk of coming back
In a main study involving 257 patients whose ALK-positive NSCLC was removed by surgery, 2-year treatment with Alecensa was compared to 4 cycles of platinum-based chemotherapy lasting 21 days each. Treatment was stopped earlier if the cancer came back or unacceptable side effects occurred. At the time of analysis, 88% of the patients given Alecensa were alive without their disease coming back, compared with approximately 61% of patients given platinum-based chemotherapy.
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