(Adnkronos) - E’ stato approvato da parte della Commissione europea l’ampliamento dell’indicazione di alectinib, un inibitore del gene Alk, come prima e unica terapia a bersaglio molecolare in adiuvante, cioè dopo l’intervento chirurgico, nel tumore al polmone non a piccole cellule (Nsclc) Alk-positivo in stadio iniziale. A portare a questa approvazione in Europa, lo studio Alina, pubblicato lo scorso aprile sulla prestigiosa rivista New England Journal of Medicine che dimostra come la terapia orale, assunta per due anni a domicilio, riduce del 76% il rischio di recidiva.
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00:00The European Commission has given the freeway to the expansion of dialectin, an inhibitor of the ALK gene, as the first and only therapy to molecular targets in adjuvants,
00:15therefore after the surgical intervention, in the lung tumor, not in small cells, positive ALK in the initial stage.
00:21To bring this approval to Europe, the study Alina, published last April, on the prestigious New England Journal of Medicine magazine.
00:29The study Alina is definitely important. I see a problem, that is, in patients who have an adenocarcinoma tumor at the early stage, operable and operated,
00:44I see the possibility that, after the surgical intervention, the disease has to recede later than when it can recede without a specific inhibitor treatment of the alteration of the ALK gene,
01:01which is identified either before the intervention or on the surgical material of the intervention.
01:07The radically operated patients were treated according to two modalities of comparison.
01:12Standard chemotherapy, which follows the surgical intervention for four cycles, that is, two months of treatment,
01:20towards two years of daily inhibitor treatment, including at home, with the drug Alektinib, which inhibits the rearrangement of the gene.
01:34These results have been important, because they have assessed a reduction of the risk of disease recidivism of over 74%.
01:50The laser ratio is 0.24, so we are at 0.76%.
01:57Today we have the so-called progression-free survival data.
02:04I measure from the beginning of the treatment until you recede, that is the PFS.
02:10Here we have an immeasurable advantage.
02:13This data will certainly translate into an increase in global survival, but it is not yet a mature data.