Approved cell and gene therapies.

Alliance for Cancer Gene Therapy drives breakthroughs to advance cell and gene therapy research that leverage the immune system to defeat all cancers. There are 10 cell and gene therapies approved by the U.S. Food and Drug Administration for cancer.

Disclaimer: Alliance for Cancer Gene Therapy is not selling or providing direct patient access to cell and gene therapy products or procedures. Any links provided to clinical trial or pharmaceutical product websites are done for informational purposes only. We are not responsible for the privacy and security practices of any other website or the nature of the content contained therein.

The approved cell and gene therapies for cancer are:

  • Abecma
  • Adstiladrin
  • Amtagvi
  • Breyanzi
  • Carvykti
  • Imlygic
  • Kymriah
  • Provenge
  • Tecartus
  • Yescarta

Approved CAR T-cell therapies for cancer.

CAR T-cell therapies help the immune system detect cancer by adding chimeric antigen receptors (CARs) to a patient’s existing T cells. Once inside T cells, CARs find and bind to specific protein molecules that exist in blood cancer cells. After they’re bound together, the genetically engineered T cells can destroy the cancer cells in the same way that they destroy other disease-causing cells.

There are six approved CAR T-cell therapies, listed below in the order of when they were approved. They are all approved for specific types of blood cancer. For patients interested in learning more about CAR T-cell therapy availability, please visit this resource for a directory of medical institutions offering at least one FDA-approved CAR T-cell therapy.

Kymriah

Kymriah (tisagenlecleucel) is a prescription cancer treatment used in patients up to 25 years of age who have acute lymphoblastic leukemia that is either relapsing (went into remission, then came back) or is refractory (did not go into remission after receiving other leukemia treatments). It is also used in patients with large B-cell lymphoma or follicular lymphoma, two types of non-Hodgkin lymphoma, that have relapsed or are refractory after having at least two other kinds of treatment.

Yescarta

YESCARTA (axicabtagene ciloleucel) is a prescription medicine used to treat two types of non-Hodgkin lymphoma:

  • Large B-cell lymphoma when your first treatment did not work or your cancer returned within a year of first treatment, or when at least two kinds of treatment have failed to control your cancer
  • Follicular lymphoma when at least two kinds of treatment have failed to control your cancer

Tecartus

TECARTUS (brexucabtagene autoleucel) is a treatment for adults with mantle cell lymphoma or acute lymphoblastic leukemia. It is used following disease progression while on or after other treatment. TECARTUS is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.

Breyanzi

BREYANZI (lisocabtagene maraleucel) is a prescription medicine used to treat three types of non-Hodgkin lymphoma:

  • Large B-cell lymphoma when your first treatment has not worked or your cancer returned within a year of your first treatment; your first treatment has not worked or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age; or two or more kinds of treatment have not worked or stopped working
  • Chronic lymphocytic leukemia or small lymphocytic lymphoma when two or more kinds of treatment have not worked or stopped working
  • Follicular lymphoma when two or more kinds of treatment have not worked or stopped working

Abecma

ABECMA (idecabtagene vicleucel) is a prescription medicine for the treatment of multiple myeloma in patients who have received at least two kinds of treatment regimens that have not worked or have stopped working. ABECMA is a medicine made from your own white blood cells; the cells are genetically modified to recognize and attack your multiple myeloma cells.

Carvykti

CARVYKTI (ciltacabtagene autoleucel) is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. It is used when at least one other treatment has not worked or has stopped working.

Other approved cell and gene therapies for cancer.

There are four other approved cell and gene therapies for cancer: a personalized vaccine; an oncolytic virus; a gene therapy; and a tumor-infiltrating lymphocytes therapy. They are approved for certain types of solid tumors.

Personalized vaccines target cancer-specific proteins to activate a patient’s immune cells. Oncolytic viruses are engineered to only infect cancer cells and activate an immune response. Gene therapy delivers a gene that helps the immune system target cancer cells. Tumor-infiltrating lymphocyte therapy multiplies immune cells that are attacking the tumor.

Provenge

PROVENGE (sipuleucel-T) is a prescription medicine used to treat certain men with advanced prostate cancer. PROVENGE is an established cellular immunotherapy and is customized to each individual by using his own immune cells.

Imlygic

IMLYGIC, (talimogene laherparepvec), is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands.

Adstiladrin

ADSTILADRIN (nadofaragene firadenovec-vncg) is a treatment for adults who have all the following:

  • High-risk, non–muscle-invasive bladder cancer that is no longer responding to Bacillus Calmette-Guérin (BCG) therapy
  • Cancer that started in the bladder and has not spread (this is called carcinoma in situ or CIS)
  • Cancer with or without slender, finger-like tumor growths (papillary tumors) growing into the bladder space, away from the bladder wall

Amtagvi

AMTAGVI (lifileucel) is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma. AMTAGVI is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation-positive, a BRAF-inhibitor drug with or without a MEK inhibitor drug that has also stopped working.