Autolus Achieves UK MHRA Approval for AUCATZYL

Deal News | Apr 25, 2025 | Syncona

Autolus Achieves UK MHRA Approval for AUCATZYL

Autolus Therapeutics has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for AUCATZYL (obecabtagene autoleucel), a CD19 CAR T cell therapy, to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This authorization was informed by results from the FELIX clinical trial. Autolus, a biopharmaceutical entity focusing on tailored T cell therapies, views this as a critical milestone, bolstering its presence in the biopharmaceutical domain. The company is also collaborating with the National Institute for Health and Care Excellence (NICE) to secure broader access through the NHS, acknowledging the significance of addressing unmet needs in adult B-ALL treatment. Dr. Claire Roddie, lead investigator of the FELIX study, noted the trial's successful outcomes, with 76.6% achieving a Complete Response/Complete Response with Incomplete Hematological Recovery (CR/CRi). Despite some significant adverse reactions, the potential for improving survival rates among r/r ALL patients marked a significant step forward. Autolus continues its development, with a focus on additional regulatory approvals and treatment accessibility.

Sectors

  • Biopharmaceuticals
  • Healthcare Regulation

Geography

  • United Kingdom – The UK is central to the article, being the location where Autolus is pursuing market authorisation for its therapy AUCATZYL and engaging with UK regulatory agencies such as MHRA and NICE.
  • United States – Though primarily set in the UK, the company's operations and clinical trials extend into the United States. Autolus is listed on the Nasdaq stock exchange, highlighting a US connection.

Industry

  • Biopharmaceuticals – The article focuses on Autolus Therapeutics, a biopharmaceutical company specialising in T cell therapies and the development and licensing of AUCATZYL for treatig relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
  • Healthcare Regulation – The article involves the UK Medicines and Healthcare products Regulatory Agency (MHRA), which plays a pivotal role in authorising and regulating medicines, including granting conditional marketing authorisation for AUCATZYL.

Financials

    Participants

    NameRoleTypeDescription
    Autolus Therapeutics plcTarget CompanyCompanyA biopharmaceutical company focused on developing programmed T cell therapies for cancer treatment.
    SynconaPrivate Equity FirmCompanyAn investment firm with interests in life sciences, including a stake in Autolus.
    UK Medicines and Healthcare products Regulatory Agency (MHRA)Regulatory BodyGovernmentUK's governmental agency responsible for licensing medicines, granted conditional authorisation for AUCATZYL.
    National Institute for Health and Care Excellence (NICE)AdvisorGovernmentProviding guidance to NHS in England on medicine cost-effectiveness, involved in potential NHS inclusion of AUCATZYL.
    University College London (UCL)CollaboratorEducational InstitutionPartners with Autolus in developing CAR T cell technology, instrumental in AUCATZYL's development and trial execution.