PET PET
  • My Account
  • Subscribe
Become a Friend Donate
  • About Us
    • People
    • Press Office
    • Our History
  • Get Involved
    • Become a Friend of PET
    • Volunteer
    • Campaigns
    • Writing Scheme
    • Partnership and Sponsorship
    • Advertise with Us
  • Donate
    • Become a Friend of PET
  • BioNews
    • News
    • Comment
    • Reviews
    • Elsewhere
    • Topics
    • Glossary
    • Newsletters
  • Events
    • Upcoming Events
    • Previous Events
  • Engagement
    • Policy and Projects
      • Resources
    • Education
  • Jobs & Opportunities
  • Contact Us
  • About Us
    • People
    • Press Office
    • Our History
  • Get Involved
    • Become a Friend of PET
    • Volunteer
    • Campaigns
    • Writing Scheme
    • Partnership and Sponsorship
    • Advertise with Us
  • Donate
    • Become a Friend of PET
  • BioNews
    • News
    • Comment
    • Reviews
    • Elsewhere
    • Topics
    • Glossary
    • Newsletters
  • Events
    • Upcoming Events
    • Previous Events
  • Engagement
    • Policy and Projects
      • Resources
    • Education
  • Jobs & Opportunities
  • Contact Us
  • My Account
  • Subscribe
  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements
PETBioNewsNewsFDA approves second gene therapy for cancer

BioNews

FDA approves second gene therapy for cancer

Published 31 October 2017 posted in News and appears in BioNews 923

Author

Jen Willows

Legal Editor
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.

The US Food and Drug Administration have approved the world’s second gene therapy to target blood cancer...

The US Food and Drug Administration (FDA) have approved the world's second gene therapy to target blood cancer.

The therapy, Yescarta, is intended for adult patients with large B-cell lymphoma for whom the conventional types of treatment have failed.

'Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,' said FDA commissioner Scott Gottlieb. 'Gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer.'

Large B-cell lymphoma is the most common form of non-Hodgkin's lymphoma, which account for four percent of cancers in the US. Currently, up to half of all patients with large B-cell lymphoma relapse or become resistant to treatments, which may include chemotherapy and stem cell transplants.

The new gene therapy, Yescarta, is a 'living drug' made from the patient's own immune cells. Like the first gene therapy for blood cancer, Kymriah (see BioNews 916), creating Yescarta requires extracting the patient's T-cells and modifying them to include a gene coding for chimeric antigen receptor (CAR). The so-called CAR-T cells are transfused back into the patient where they are better able to target and destroy cancer cells.

The drug was originally developed at the National Cancer Institute by a team led by Dr Steven Rosenberg. Yescarta was acquired by Kite Pharma in 2012, which was bought by pharma giant Gilead in August.

The FDA reported that 100 patients treated with Yescarta had a 51 percent complete remission rate in a multicentre clinical trial.

However, like other CAR-T therapies (see BioNews 917), the treatment carries the risk of life-threatening side effects, including high fever, low blood pressure, lung congestion and neurological problems. As a result the FDA requires hospitals and clinics to have special certification to provide the therapy.

'We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies,' said Gottlieb.

The New York Times reported the treatment takes about 17 days overall to be developed and available for a patient.

'I believe this treatment approach brings hope to many patients, but one thing to consider is cost,' said Dr Michaela Almgren of the University of South Carolina College of Pharmacy.

Gilead have priced Yescarta at $373,000 for a one-time dose.

Related Articles

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
4 February 2022 • 2 minutes read

Leukaemia patients still in remission a decade after CAR-T gene therapy

by Farah Alam

Two patients who received CAR-T gene therapy over a decade ago are still in remission, the longest follow-up study of its kind has shown...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
3 December 2021 • 2 minutes read

Candidate drug targeting metastasis could stop cancer spreading

by James Moore

Researchers have identified a molecule that could be used as a drug to prevent metastasis, a process by which cancer can spread and cause death...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
26 February 2018 • 2 minutes read

FDA issues warning on DIY gene-therapy kits

by Theofanis Michailidis

The US Food and Drug Administration (FDA) is taking an active stance against the use of 'do it yourself' gene therapy kits...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
4 December 2017 • 2 minutes read

FDA to speed up gene therapy and regenerative medicine approvals

by Martha Henriques

The US Food and Drug Administration has announced a fast-track review process for gene therapies and other regenerative medicine treatments...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
16 October 2017 • 3 minutes read

FDA advisors back gene therapy for rare inherited blindness

by Rikita Patel

The US Food Drug and Administration advisory committee has backed the use of gene therapy to treat a hereditary disease for the first time...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
20 September 2017 • 2 minutes read

Gene therapy for cancer halted after patient death

by Ebtehal Moussa

Two trials assessing gene therapy for blood cancer have been put on hold by the US Food and Drug Administration, following a patient fatality...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
12 September 2017 • 2 minutes read

First gene therapy for leukaemia approved

by Meetal Solanki

The world's first cancer treatment which uses a patient's own genetically modified immune cells has been approved...

Leave a Reply Cancel reply

You must be logged in to post a comment.

« No legal father for IVF baby, rules Georgia Supreme Court

Data-Label The UK's Leading Supplier Of Medical Labels & Asset Labels

RetiringDentist.co.uk The UK's Leading M&A Company.

Find out how you can advertise here
easyfundraising
amazon

This month in BioNews

  • Popular
  • Recent
8 August 2022 • 2 minutes read

Placenta and organ formation observed in mouse embryo models

8 August 2022 • 2 minutes read

Lower hormone doses may improve IVF egg quality

8 August 2022 • 2 minutes read

Boosting muscle cell production of gene therapy proteins

1 August 2022 • 2 minutes read

First UK medical guidelines issued for trans fertility preservation

1 August 2022 • 2 minutes read

Male age has more impact on IVF birth rate than previously thought

8 August 2022 • 2 minutes read

Placenta and organ formation observed in mouse embryo models

8 August 2022 • 2 minutes read

Complex structures of the human heart bioengineered

8 August 2022 • 1 minute read

Brain tumour gene also linked to childhood cancers

8 August 2022 • 2 minutes read

Lower hormone doses may improve IVF egg quality

8 August 2022 • 2 minutes read

Boosting muscle cell production of gene therapy proteins

Subscribe to BioNews and other PET updates for free.

Subscribe
  • Twitter
  • Facebook
  • Instagram
  • LinkedIn
  • YouTube
  • RSS
Wellcome
Website redevelopment supported by Wellcome.

Website by Impact Media Impact Media

  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements

© 1992 - 2022 Progress Educational Trust. All rights reserved.

Limited company registered in England and Wales no 07405980 • Registered charity no 1139856

Subscribe to BioNews and other PET updates for free.

Subscribe
PET PET

PET is an independent charity that improves choices for people affected by infertility and genetic conditions.

  • Twitter
  • Facebook
  • Instagram
  • LinkedIn
  • YouTube
  • RSS
Wellcome
Website redevelopment supported by Wellcome.

Navigation

  • About Us
  • Get Involved
  • Donate
  • BioNews
  • Events
  • Engagement
  • Jobs & Opportunities
  • Contact Us

BioNews

  • News
  • Comment
  • Reviews
  • Elsewhere
  • Topics
  • Glossary
  • Newsletters

Other

  • My Account
  • Subscribe

Website by Impact Media Impact Media

  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements

© 1992 - 2022 Progress Educational Trust. All rights reserved.

Limited company registered in England and Wales no 07405980 • Registered charity no 1139856