Treatment of Solid Tumors including Metastatic Breast Cancer

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Citizen Petition Reconsider Issuance of RMAT Designation for Therapeutic Armed Activated T Lymphocytes Treatment of Solid Tumors including Metastatic Breast Cancer

The undersigned submits this petition under to request the Commissioner of Food and Drugs to reconsider issuing a Regenerative Medicine Advanced Therapy (RMAT) designation to autologous T-lymphocyte therapies for patients with malignant advanced stage solid tumors, specifically stage IV metastatic breast cancer, on the basis that it can meet an unmet medical need as substantiated by new clinical trial evidence resulting from trial involving OKT3 x Herceptin Armed Activated T Cells, Low Dose IL-2, and GM-CSF, as relevant to section 506(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3033 of the 21st Century Cures Act (Cures Act). A. Action Requested The Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Draft Guidance for Industry states that in order for an investigational drug to receive a Regenerative Medicine Advanced Therapy (RMAT) designation it must fulfill the following criteria1:.

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  • It meets the definition of regenerative medicine therapy (see section I of [draft guidance] document)
  • It is intended to treat, modify, reverse or cure a serious condition; and
  • Preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition The Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Draft Guidance for Industry states that the definition of regenerative medicine therapy is1: • Cell therapies, therapeutic tissue engineering products, human cell, and tissue products, and combination products using any such therapies or product And
  • Gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues may meet the definition of a regenerative medicine therapy.
  • In said draft guidance, unmet medical need is defined as: • An unmet medical need is a condition whose treatment or diagnosis is not addressed adequately by available therapy. An unmet medical need includes an immediate need for a defined population (i.e., to treat a serious condition with no or limited treatment) or a longer-term need for society (e.g., to address the development of resistance to antibacterial drugs).

    We, the undersigned, petition the Commissioner of Food and Drugs to reconsider issuing an RMAT designation to autologous T-Lymphocyte therapies for solid tumors, and we offer new clinical trial data from the trial named Treatment of Stage IV Breast Cancer With OKT3 x Herceptin Armed Activated T Cells, Low Dose IL-2, And GM-CSF (NCT00027807) as clinical evidence that indicates the potential to meet an unmet medical need thereby fulfilling the requirement “that the regenerative medicine therapy has the potential to address unmet medical needs for such condition” listed in The Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Draft Guidance for Industry.1 B.

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