Regulatory News


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FDA Approves Axi-Cel for Relapsed/Refractory Indolent Follicular Lymphoma

The FDA has granted an accelerated approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory indolent follicular lymphoma after 2 or more lines of systemic therapy.

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AEMPS authorises Hospital Clínic's CAR-T ARI-0001 for patients with acute lympho...

The Spanish Agency of Medicines and Medical Devices (AEMPS) has approved CAR-T ARI-0001, developed by Hospital Clínic, as and advanced therapy drug of non-industrial production for its use in patients over 25 years of age with lymphoblastic leukaemia that is resistant to conventional treatments. It is the first CAR-T developed entirely in Europe to be approved by a regulatory agency.

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Keytruda Closer to Expanded EU Approval for Pediatric Resistant Hodgkin’s Lympho...

Keytruda (pembrolizumab) has been recommended for approval in the European Union (EU) to treat adults and children, 3 years and older, with relapsed or refractory classical Hodgkin’s lymphoma (cHL) whose disease failed to respond to autologous stem cell transplant (ASCT) or who received at least two prior therapies when ineligible for ASCT.

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FDA approves cell-based gene therapy to treat adults with relapsed or refractory...

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.

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Anti-CD19 CAR-T cells therapy (Tecartus) has been autorized for use in mantle ce...

Tecartus is a cancer medicine used to treat adults with mantle cell lymphoma. It is used when the cancer has come back after two or more previous treatments including a type of cancer medicine called a Bruton’s tyrosine kinase (BTK) inhibitor. Mantle cell lymphoma is rare, and Tecartus was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 13 November 2019. The active substance in Tecartus consists of genetically modified white blood cells (called autologous anti-CD19-transduced CD3+ cells).

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Pembrolizumab Approaches EU Approval for Expanded Indication in Relapsed/Refract...

The European Medicines Agency’s Committee of Medicinal Products for Human Use has recommended a label expansion for pembrolizumab for use as a single agent in adult and pediatric patients aged 3 years and older with relapsed/refractory classical Hodgkin lymphoma for whom autologous stem cell transplant has failed or following at least 2 previous therapies when ASCT is not an option.

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FDA Grants Orphan Drug Designation to BCMA-Targeted TriTAC HPN217 for Myeloma

  Jan 13 2021 Tagged MM, anti-BCMA

The FDA has granted an orphan drug designation to the BCMA-targeted trispecific T-cell activating recombinant protein construct (TriTAC) as treatment for patients with multiple myeloma, according to an announcement from Harpoon Therapeutics, Inc.

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Liso-Cel BLA for Relapsed/Refractory LBCL Remains Under FDA Review

The biologics license application for the CAR T-cell product lisocabtagene maraleucel in adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies continues to be under regulatory review by the FDA, and a decision on the application has not yet been reached.

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The EMA Review of Belantamab Mafodotin (Blenrep) for the Treatment of Adult Pati...

  Nov 11 2020 Tagged mAbs, MM

This is the first monoclonal antibody to target this antigen in multiple myeloma, which represents a true novelty from a pharmacological point of view.

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Evolving use of real-world evidence in the regulatory process: a focus on immuno...

This article reviews current literature on the use of RWE for regulatory submissions, with a focus on novel anticancer immunotherapies, and discusses the utility and current limitations of RWE in the context of drug development and regulatory approvals.

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