EU Follows US and Approves Chugai's ALK Inhibitor "Alecensa®" as First Line Therapy for ALK-Positive Non-Small Cell Lung Cancer
Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that F. Hoffmann-La Roche Ltd. obtained approval from the European Commission, for Alecensa® as monotherapy indicated for “the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)”. In addition, the EU marketing authorisation for Alecensa has been switched from conditional approval (given in February 2017) to a full approval for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line).
"Following approval for first line treatment in the US in November 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in the EU. An improvement in prognosis is expected in patients with ALK-positive advanced NSCLC who receive treatment with Alecensa at an early stage,” said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. “In addition to the J-ALEX study (JapicCTI-132316) conducted in Japan, results of the ALEX study (NCT02075840) conducted overseas also showed that this will be great news for patients. We are convinced that Alecensa can contribute to the treatment of many patients in the world."
This additional approval is based on results from the phase III ALEX
The ALEX study (NCT02075840) evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line). In the study, Alecensa significantly reduced the risk of disease worsening or death by 53% (HR=0.47, 95%CI: 0.34-0.65, stratified log-rank test, p<0.001) compared to crizotinib as assessed by investigators. Median progression-free survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib as assessed by independent review committee. The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.
In addition, Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95%CI: 0.10-0.28, stratified log-rank test, p<0.001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).
Alecensa is a highly selective oral ALK inhibitor discovered by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells.2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases.
Outside of Japan, Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Thailand, Liechtenstein, Argentina, United Arab Emirates, Saudi Arabia and Turkey for the treatment of people with metastatic (advanced) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in the US, EU and Turkey for the treatment of first line therapy on ALK-positive metastatic NSCLC.
In Japan, Alecensa is available to patients with “ALK fusion gene positive unresectable, recurrent/advanced NSCLC” and is marketed by Chugai. The approved dosage and administration in Japan is "300mg alectinib administered orally twice daily for adult patient."
|1)||Biomarker committee of The Japan Lung Cancer Society, Guidelines for ALK gene tests in lung cancer patients|
|2)||Soda et al., Nature. 448: 561-566 (2007)|
|3)||Takeuchi et al., Clin Cancer Res. 15: 3143-3149 (2009)|
|4)||Sakamoto et al., Cancer Cell. 19: 679-690 (2011)|
|Note:||The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.|
Chugai Pharmaceutical is one of Japan’s leading research-based
pharmaceutical companies with strengths in biotechnology products.
Chugai, based in Tokyo, specializes in prescription pharmaceuticals and
is listed on the 1st section of the Tokyo Stock Exchange. As an
important member of the Roche Group, Chugai is actively involved in R&D
activities in Japan and abroad. Specifically, Chugai is working to
develop innovative products which may satisfy the unmet medical needs,
mainly focusing on the oncology area.
In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.
The consolidated revenue in 2016 of Chugai totalled 491.8 billion yen and the operating income was 80.6 billion yen (IFRS Core basis).
Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.
Trademarks used or mentioned in this release are protected by law.
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
For US media
Chugai Pharma USA Inc.
For European media
Chugai Pharma France SAS
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Lehman Brothers Treasury to Further Explore Strategic Opportunities15.10.2018 19:54 | Tiedote
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that the liquidators of LBT are continuing to explore various strategies to, among other things, facilitate the consolidation of the LBT creditor base and the wind-down of the LBT estate. To that end, the liquidators of LBT intend to engage with certain of LBT’s creditors and other market participants regarding potential strategies, including, but not limited to, a potential sale of a portion of LBT’s assets. No assurances can be made that any strategy will be employed, or if one is employed, the timing of its implementation. LBT does not undertake to publicly update its disclosure to reflect developments in this matter. View source version on businesswire.com: https://www.businesswire.com/news/home/20181015005777/en/ Contact information Kramer Levin Naftalis & Frankel LLP Daniel Eggermann, 212-715-9495
SFL – Third-Quarter 2018 Financial Information15.10.2018 19:28 | Tiedote
Regulatory News: SFL (Paris:FLY): Consolidated revenue by business segment (€000's) 2018 (9 months) 2017 (9 months) Rental income 143,790 147,819 o/w Paris Central Business District 119,038 114,326 Paris Other 22,479 21,526 Western Crescent 2,273 11,967 Other revenue 0 0 Total consolidated revenue 143,790 147,819 At €143.8 million, consolidated rental income for the first nine months of 2018 was down €4.0 million or 2.7% compared to the €147.8 million reported for the same period of 2017. The decline was due to the disposal of the IN/OUT property in September 2017, the effects of which were offset to a significant extent by growth in like-for-like income. On a like-for-like basis (excluding all changes in the portfolio affecting period-on-period comparisons), rental income was €6.0 million (4.6%) higher, reflecting the contribution of new leases signed in 2017 and 2018, mainly in the Washington Plaza, 103 Grenelle, Cézanne Saint-Honoré and 9 Percier properties, as well as an increase i
Hilton Earns #2 Spot as World’s Best Workplace15.10.2018 18:54 | Tiedote
For the third consecutive year, Hilton has been named as one of the World’s Best Workplaces recognized by Great Place to Work®. Hilton climbed seven spots to the highly coveted second spot on the list of the top 25 companies and is the only hospitality company in the top ten. Team Members from the world’s most hospitable company say Hilton’s culture, benefits and travel perks make it a great place for a career. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005711/en/ Hilton President & CEO Chris Nassetta with Team Members. (Photo: Business Wire) “Our Team Members are the heart of our business, and they have been the driving force behind our growth and success around the world for nearly 100 years,” said Christopher J. Nassetta, president & CEO of Hilton. “As the pioneers of hospitality, we are dedicated to creating exceptional experiences for every person we meet - and this starts with our Team Members, who make all o
IDEMIA Appoints Yann Delabrière as Group CEO15.10.2018 17:53 | Tiedote
The supervisory board of IDEMIA, the global leader in Augmented Identity, has appointed Yann Delabrière to be Chief Executive Officer with immediate effect taking over from Didier Lamouche who has resigned. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005635/en/ Yann Delabrière (credit Pierre Charriau/IDEMIA) One year after the successful coming together of Oberthur Technologies (OT) and Safran I&S (Morpho) that gave rise to IDEMIA, Yann Delabrière will be charged with overseeing a new phase in the Group’s growth. Yann Delabrière, who previously served as CEO of Faurecia followed by CEO of Zodiac Aerospace, was appointed IDEMIA’s supervisory board chairman in January 2018. Since then he has gained in-depth understanding of the Company’s operations and people. IDEMIA will now look to benefit from Yann’s extensive international managerial experience. Yann Delabrière stated: “I am delighted that the Supervisory Board is
9 in 10 Enterprises Report Gaps Between the Cybersecurity Culture They Have and the One They Want15.10.2018 16:35 | Tiedote
With cybersecurity threats continuing to escalate worldwide, the ISACA/CMMI Institute Cybersecurity Culture Report found that just 5 percent of employees think their organization’s cybersecurity culture is as advanced as it needs to be to protect their business from internal and external threats. More than 4,800 business and technology professionals shared their insights in the global research study, conducted via online polling in June 2018. Results were released today at ISACA’s CSX North America cybersecurity conference in Las Vegas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005149/en/ New global research from ISACA and the CMMI Institute shows 95% of organizations say there is a gap between the cybersecurity cultures they have and the ones they want. (Graphic: Business Wire) Cybersecurity culture is a workplace culture in which security awareness and behaviors are integrated into everyone’s daily operations, a
AirFit F30, ResMed’s First Minimal-Contact Full Face CPAP Mask, Now Available in the U.S., Canada15.10.2018 16:05 | Tiedote
ResMed (NYSE: RMD, ASX: RMD) today announced the availability of its first minimal-contact full face CPAP mask, AirFit F30, the latest addition to its AirFit mask portfolio, which helps sleep apnea patients reduce facial marks, wear glasses in bed and curl up closer to their bed partner. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005185/en/ AirFit F30 full face CPAP mask: Side View (Photo: Business Wire) Availability AirFit F30 is available for sale now in the United States and Canada, and will be on display at the Medtrade Fall conference this week in Atlanta; visit ResMed’s Booth #2116. AirFit F30 fits 93 percent of patients,1 and features a minimal-contact cushion that sits just below the nose, preventing top-of-the-nose red marks and irritation, plus reducing feelings of claustrophobia for some full face wearers. It also has ResMed’s QuietAir vent, making the mask quieter than ambient noise in the bedroom. New
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme