TOKYO–(BUSINESS WIRE)– Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) heeft vandaag bekendgemaakt dat de Amerikaanse Food and Drug Administration (FDA) het geneesmiddel Alecensa® de status van Doorbraaktechnologie tegen eerstelijns ALK-positieve niet-kleincellige longkanker verleent. Het door Chugai ontwikkelde Alecensa® is een zeer selectieve ALK-inhibitor. Het medicijn is goedgekeurd in Japan en de Verenigde Staten. In Europa heeft Roche het middel ter goedkeuring ingediend.
“We zijn erg blij dat Alecensa voor de tweede keer de status van Doorbraaktherapie heeft gekregen, de vierde doorbraakstatus voor een medicijn van Chugai”, zei Yasushi Ito, senior vicepresident van Chugai en hoofd van de afdeling Project & Lifecycle Management. “Deze status onderstreept dat de geneeskundige waarde van Alecensa zeer hoog wordt aangeslagen en dat het medicijn veel potentie heeft voor de behandeling van ALK-positieve niet-kleincellige longkanker.”
Chugai’s Alecensa® Receives Breakthrough Therapy Designation from FDA for First-Line Treatment of ALK Positive Non-Small Cell Lung Cancer
TOKYO–(BUSINESS WIRE)– Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the first-line treatment of ALK positive non-small cell lung cancer (NSCLC) to Alecensa ®, a highly selective ALK inhibitor created by Chugai. Alecensa ® is approved in Japan and in the United States, and filed in Europe by Roche.
“We are pleased that Alecensa has received Breakthrough Therapy Designation for the second time, which also marks the fourth BTD for Chugai originated drugs,” said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. “This designation underscores that the medical value of Alecensa is highly appreciated, and that the drug has great potential to the treatment of ALK positive NSCLC.”
This designation is based on the J-ALEX study, conducted by Chugai, which is an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who had not undergone chemotherapy or had undergone one chemotherapy regimen. The subjects were allocated to either the Alecensa arm or the crizotinib arm in a one to one ratio. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by a blinded independent review board. The secondary endpoints included overall survival, objective response rate and safety. In February 2016, an independent data monitoring committee recommended to discontinue the J-ALEX study early for benefit based on the results of the predetermined interim analysis which was examined by the committee.
The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34, and Alecensa demonstrated significantly prolonged PFS (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001). Median PFS was not reached (95% CI: 20.3-Not reached) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea, diarrhea, vomiting, visual disturbance, dysgeusia, constipation, ALT elevation and AST elevation were observed in >30% patients. Grade 3-4 AEs occurred in 27% of the Alecensa arm and in 51% of the crizotinib arm, with no treatment-related deaths in both arms.
This is the fourth Breakthrough Therapy Designation for Chugai originated drugs following Alecensa (ALK positive, metastatic NSCLC in patients who have progressed on or those who are intolerant to crizotinib), Actemra (systemic sclerosis), and emicizumab (prophylactic treatment for 12 years or older patients with hemophilia A with factor VIII inhibitors).
Based on Chugai’s business philosophy of “Innovation all for the patients,” Chugai will collaborate with Roche and Genentech to receive approval for the early use of Alecensa in a number of countries around the world.
About Breakthrough Therapy Designation
In Japan, Alecensa is available to patients with “ALK fusion gene positive unresectable, recurrent/advanced NSCLC” and is marketed by Chugai. In the US, Alecensa was approved in December 2015 for the indication of “ALK positive, metastatic NSCLC in patients who have progressed on or those who are intolerant to crizotinib.” In September 2015, Roche filed the MAA in Europe to the European Medicines Agency for the approval of “ALK fusion gene positive unresectable, recurrent/advanced NSCLC.”