FDA approval of the first cellular therapy for a solid (non-hematologic) cancer

The first US Food and Drug Administration-approved cellular therapy for treating a solid (non-hematologic) malignancy was granted accelerated approval on February 16, 2024. 1 FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma. 2024https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma Google Scholar The therapy, lifileucel (Amtagvi), is manufactured by Iovance Biotherapeutics. 1 FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma. 2024https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma Google Scholar Approval was for adult patients with unresectable or metastatic melanoma that was previously treated with standard therapies, and approval was based on results showing an overall response rate of 31.5% (95% confidence interval: 21.1%, 43.4%). 1 FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma. 2024https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma Google Scholar The median duration of responses was not reached. 1 FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma. 2024https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma Google Scholar ,2 Chesney J. Lewis K.D. Kluger H. Hamid O. Whitman E. Thomas S. Wermke M. Cusnir M. Domingo-Musibay E. Phan G.Q. et al. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: Pooled analysis of consecutive cohorts of the C-144-01 study. J. Immunother. Cancer. 2022; 10e005755https://doi.org/10.1136/jitc-2022-005755 Crossref Scopus (24) Google Scholar Lifileucel is manufactured by in vitro culture of tumor-infiltrating lymphocytes (TILs) from surgically resected autologous tumor fragments. 3 Sarnaik A.A. Hamid O. Khushalani N.I. Lewis K.D. Medina T. Kluger H.M. Thomas S.S. Domingo-Musibay E. Pavlick A.C. Whitman E.D. et al. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. J. Clin. Oncol. 2021; 39: 2656-2666https://doi.org/10.1200/JCO.21.00612 Crossref PubMed Scopus (108) Google Scholar The therapy includes lymphocyte-depleting chemotherapy followed by lifileucel infusion and a course of interleukin-(IL)-2. 1 FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma. 2024https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma Google Scholar ,2 Chesney J. Lewis K.D. Kluger H. Hamid O. Whitman E. Thomas S. Wermke M. Cusnir M. Domingo-Musibay E. Phan G.Q. et al. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: Pooled analysis of consecutive cohorts of the C-144-01 study. J. Immunother. Cancer. 2022; 10e005755https://doi.org/10.1136/jitc-2022-005755 Crossref Scopus (24) Google Scholar