Loading
  • Facebook
  • LinkedIn
  • Twitter
  • Instagram
  • Pinterest
  • Youtube
  • Mail
  • Rss
  • Log In
    • Register
Contacts us @ MediPr.org
Medical Writer Agency | 香港醫學作家 | MediPR | MediPaper Hong Kong
  • MDnews
  • About [‘mediPr]
  • Search
  • Menu Menu

Non-Sponsored Content

Share this entry
  • Share on Facebook
  • Share on Twitter
  • Share on WhatsApp
  • Share on Pinterest
  • Share on LinkedIn
  • Share on Tumblr
  • Share by Mail


MEDICAL NEWS ASIA

CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW

By: News Feed | Last updated: 5th October 2018 | In: Haematology, ImmunoOncology, Immunotherapy, Medical News Asia, Oncology

Article Keywords

axicabtagene ciloleucel, B-cell lymphoma, CAR-CD19-T, CAR-T, CD19, Daiichi Sankyo, DLBCL, Gilead Sciences, HGBL, Kite Pharma, KTE-C19, lymphoma, NHL, non-Hodgkin, PMBCL, TFL, Yescarta

TOKYO and BASKING RIDGE, N.J., October 3, 2018 /PRNewswire/ — The Japan Ministry of Health, Labour and Welfare (MHLW) granted the Orphan Drug designation to axicabtagene ciloleucel (KTE-C19, Daiichi Sankyo) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL), and transformed follicular lymphoma (TFL), which are all aggressive forms of non-Hodgkin lymphoma (NHL).

“Receiving Orphan Drug designation is an important step in expediting the development of axicabtagene ciloleucel in Japan and underscores the unmet needs of patients with these aggressive forms of relapsed or refractory B-cell lymphomas”

Kouichi Akahane, Head of Oncology Function, R&D Division, Daiichi Sankyo

Axicabtagene ciloleucel is a chimeric antigen receptor T-cell (CAR-T) therapy directed against CD19. The drug enables the patient’s innate immune system to eradicate certain types of B-cell lymphoma cells. Axicabtagene ciloleucel was previously approved in the United States (US) and Europe based on the results of the Phase 1/2 ZUMA-1 study. A similar design study to the ZUMA-1 is currently being planned in Japan.

Daiichi Sankyo obtained the exclusive development, manufacturing and commercialisation rights in Japan for axicabtagene ciloleucel from Kite Pharma, a Gilead company. In the US and Europe, the CAR-T therapy is marketed as Yescarta®.

The Orphan Drug designation system by the Japan MHLW is designed to promote research and support the development of therapies for severe and difficult-to-treat diseases affecting less than 50,000 Japanese patients, and for which a major unmet medical need.

References

Daiichi Sankyo. (2018, October 03) Japan MHLW Grants Orphan Drug Designation to Axicabtagene Ciloleucel for Treatment of Certain Types of B-Cell Lymphoma [Press Release]. Retrieved from https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006911.html


Newsletter Sign-Up

Do you like our content? Subscribe to our non-intrusive newsletter today! We promise we won’t be spammy.

Newsletter Sign-Up


YOU MAY ALSO LIKE

Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?

Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?

https://medi-paper.com/wp-content/uploads/2019/04/Can-a-novel-temporary-and-fully-resorbable-surgical-implant-improve-the-outcome-of-common-hockey-and-soccer-injuries.jpg 1000 1500 Stijn van den Borne, MSc https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png Stijn van den Borne, MSc2019-04-26 20:05:262019-04-26 20:12:32Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?
Erasmus University MC investigating a new surgical matrix to reduce post-operative complications

Erasmus University MC investigating a new surgical matrix to reduce post-operative complications

https://medi-paper.com/wp-content/uploads/2019/01/Erasmus-University-MC-investigating-a-new-surgical-matrix-to-reduce-post-operative-complications.jpg 900 1500 Stijn van den Borne, MSc https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png Stijn van den Borne, MSc2019-01-16 22:58:582019-01-16 23:09:21Erasmus University MC investigating a new surgical matrix to reduce post-operative complications
TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy

TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy

https://medi-paper.com/wp-content/uploads/2018/12/TIGR®Matrix-shows-promising-results-when-used-for-incisional-hernia-prevention-in-septic-patients-undergoing-laparoscopy.jpg 1000 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-12-04 21:28:362018-12-05 11:50:08TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy
Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction

Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction

https://medi-paper.com/wp-content/uploads/2018/11/Fully-resorbable-synthetic-matrix-offers-improved-safety-for-breast-cancer-patients-undergoing-immediate-breast-reconstruction.jpg 1000 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-11-21 16:41:202018-12-04 21:34:06Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction
PreviousNext
Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?
26th April 2019

Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?

Erasmus University MC investigating a new surgical matrix to reduce post-operative complications
16th January 2019

Erasmus University MC investigating a new surgical matrix to reduce post-operative complications

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

© Copyright 2018 MediPaper Medical Communications Ltd. – CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW

Share this entry
  • Share on Facebook
  • Share on Twitter
  • Share on WhatsApp
  • Share on Pinterest
  • Share on LinkedIn
  • Share on Tumblr
  • Share by Mail

YOU MAY ALSO LIKE

Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?

Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?

https://medi-paper.com/wp-content/uploads/2019/04/Can-a-novel-temporary-and-fully-resorbable-surgical-implant-improve-the-outcome-of-common-hockey-and-soccer-injuries.jpg 1000 1500 Stijn van den Borne, MSc https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png Stijn van den Borne, MSc2019-04-26 20:05:262019-04-26 20:12:32Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?
Erasmus University MC investigating a new surgical matrix to reduce post-operative complications

Erasmus University MC investigating a new surgical matrix to reduce post-operative complications

https://medi-paper.com/wp-content/uploads/2019/01/Erasmus-University-MC-investigating-a-new-surgical-matrix-to-reduce-post-operative-complications.jpg 900 1500 Stijn van den Borne, MSc https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png Stijn van den Borne, MSc2019-01-16 22:58:582019-01-16 23:09:21Erasmus University MC investigating a new surgical matrix to reduce post-operative complications
TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy

TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy

https://medi-paper.com/wp-content/uploads/2018/12/TIGR®Matrix-shows-promising-results-when-used-for-incisional-hernia-prevention-in-septic-patients-undergoing-laparoscopy.jpg 1000 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-12-04 21:28:362018-12-05 11:50:08TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy
Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction

Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction

https://medi-paper.com/wp-content/uploads/2018/11/Fully-resorbable-synthetic-matrix-offers-improved-safety-for-breast-cancer-patients-undergoing-immediate-breast-reconstruction.jpg 1000 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-11-21 16:41:202018-12-04 21:34:06Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction
innovent biologics anti-pd1 sintilimab plus biosimilar bevacizumab receive ind status by china nmpa

Anti-PD1 sintilimab plus biosimilar bevacizumab receive IND-status by China NMPA

https://medi-paper.com/wp-content/uploads/2018/10/innovent-biologics-anti-pd1-sintilimab-plus-biosimilar-bevacizumab-receive-ind-status-by-china-nmpa-e1539612467836.jpg 1000 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-10-15 22:26:302018-10-17 11:29:45Anti-PD1 sintilimab plus biosimilar bevacizumab receive IND-status by China NMPA
Quizartinib Receives Orphan Drug Designation for FLT3-Mutated AML in Japan

Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan

https://medi-paper.com/wp-content/uploads/2018/09/Quizartinib-Receives-Orphan-Drug-Designation-for-FLT3-Mutated-AML-in-Japan.jpg 1000 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-09-12 22:21:342018-09-12 22:21:34Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan
CAR-TCR Summit 2018 Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer© Royaltystockphoto / 123RF Stock Photo

CAR-TCR Summit 2018: Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer

https://medi-paper.com/wp-content/uploads/2018/09/CAR-TCR-Summit-2018-Preliminary-first-in-human-data-with-CAR-Claudin18.2-T-in-gastric-and-pancreatic-cancer.jpg 1054 1505 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-09-09 09:38:282018-09-09 09:38:28CAR-TCR Summit 2018: Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer
DRIVER connects cancer patients in China and the United States to the best care© Kentoh / 123RF Stock Photo

DRIVER connects cancer patients in China and the United States to the best care

https://medi-paper.com/wp-content/uploads/2018/09/DRIVER-connects-cancer-patients-in-China-and-the-United-States-to-the-best-care.jpg 994 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-09-07 21:45:362018-09-07 21:45:36DRIVER connects cancer patients in China and the United States to the best care
First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation© luchschen / 123RF Stock Photo

First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation

https://medi-paper.com/wp-content/uploads/2018/08/First-in-Class-Oncology-Vaccine-BIL06v-Starts-Phase-1-Evaluation.jpg 1000 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-08-22 11:48:172018-08-27 09:35:59First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation
PolyU Researcher Develop Novel Self-fitting Scaffold for Bone-Regeneration©Polytech University Hong Kong

PolyU Researchers Develop Novel Self-fitting Scaffold for Bone-Regeneration

https://medi-paper.com/wp-content/uploads/2018/08/PolyU_bone_regeneration-e1534396913248.jpg 788 1184 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-08-16 13:24:162018-08-16 19:14:03PolyU Researchers Develop Novel Self-fitting Scaffold for Bone-Regeneration
Pan-EGFR TKI pirotinib has commenced into Phase II clinical testing in China©Alex011973 / 123RF Stock Photo

Pan-EGFR TKI pirotinib has commenced into Phase II clinical testing in China

https://medi-paper.com/wp-content/uploads/2018/08/Pan-EGFR-TKI-pirotinib-has-commenced-into-Phase-II-clinical-testing-in-China.jpg 1000 1500 News Feed https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png News Feed2018-08-13 23:09:022018-09-07 21:59:21Pan-EGFR TKI pirotinib has commenced into Phase II clinical testing in China
PreviousNext
0 replies

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply Cancel reply

You must be logged in to post a comment.

© Copyright 2018 MediPaper Medical Communications Ltd. – CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW

Therapeutic Areas

Or, sign up for our newsletter


© 2016-2021 MediPaper Medical Communications Ltd. | Website by [’mediPr] | 醫學作家香港 | Privacy Policy | Cookie Policy
  • Facebook
  • LinkedIn
  • Twitter
  • Instagram
  • Pinterest
  • Youtube
  • Mail
  • Rss
PD-1 mAB cemiplimab FDA approved for locally advanced and metastatic cutaneous... Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC
Scroll to top

This site uses cookies to improve your experience. By continuing to browse the site, you are agreeing to our use of cookies.

OKPrivacy Settings

Cookies and Privacy on medi-paper.com



Cookie Policy

How MediPaper uses cookies is explained in our Cookie Policy

Privacy Policy

Read MediPaper's Privacy Policy

Google Analytics cookies

These cookies collect information that is used either in aggregate form to help us understand how our website is being used or how effective our marketing campaigns are, or to help us customize our website and application for you in order to enhance your experience.

If you do not want that we track your visist to our site you can disable tracking in your browser here:

Other external services

We also use different external services like Google Webfonts, Google Maps and external Video providers. Since these providers may collect personal data like your IP address we allow you to block them here. Please be aware that this might heavily reduce the functionality and appearance of our site. Changes will take effect once you reload the page.

Google Webfont Settings:

Google Map Settings:

Vimeo and Youtube video embeds:

Accept settingsHide notification only
MediPaper Medical Communications Agency Hong Kong Blog