CAT - Monthly Report on ATMPs

In December, the 132nd meeting of the Committee for Advanced Therapies (CAT) took place. The resulting report contains statistical data on the CAT's scientific recommendations on the classification of Advanced Therapy Medicinal Products (ATMPs), certifications, initial assessments, CAT contributions to scientific recommendations and paediatric investigation plans, as well as amendments, line extensions and renewals.

Another topic was the withdrawal of the marketing authorisation application for autologous human chondrocytes (expanded in vitro) intended for the treatment of cartilage defects of the knee joint.

One focus of the meeting was the scientific recommendations on the classification ATMP medicinal products. Following consultation with the European Commission, six scientific recommendations on the classification of ATMPs were finalised and are presented below.

  • The following were classified as gene therapy medicinal products
    - Autologous CD34+ cells transduced with a lentiviral vector encoding human cystinosin, intended for the treatment of cystinosis;
    - Delolimogene mupadenorepvec (oncolytic adenovirus expressing two immunostimulatory transgenes (TMZ-CD40L and 4-1BBL)), intended for the treatment of cancer.
  • Classified as somatic cell therapy products:
    - Autologous tumour-infiltrating lymphocytes, intended for the treatment of advanced melanoma;
    - Allogeneic umbilical cord tissue-derived mesenchymal stromal cells for the treatment of inflammatory and immunological diseases (acute graft-versus-host disease, systemic lupus erythematosus, systemic sclerosis, acute respiratory distress syndrome).
  • Classified as tissue-engineered products and combined ATMPs were:
    - 3D bio-printed bionic pancreas consisting of islets of Langerhans and printable non-viable, porcine-derived matrix and decellularised porcine-derived blood vessel, intended for the treatment of late chronic pancreatitis;
    - 3D biologically printed bionic pancreas consisting of insulin and glucagon releasing cells and non-viable printable porcelain-derived matrix plus porcelain-derived decellularised blood vessel,
    intended for the treatment of brittle diabetes mellitus type I

In addition, the document contains an overview of other product-related activities such as:

  • Initial assessment of Marketing Authorisation Applications (MAA) for ATMP. 
  • Variations of Type II 
  • Scientific recommendation on advanced therapy classification
    Certification of quality and non-clinical data for small and medium-sized companies developing ATMPs 
  • others.

More details can be found directly on the EMA homepage under "CAT monthly report of application procedures, guidelines and related documents on advanced therapies".

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