Cell-Based Immunotherapy Products
A chimeric antigen receptor (CAR) T-cell therapy for adults with relapsed or refractory multiple myeloma. Approved by the US FDA in March 2021. Approved by Health Canada in May 2021. Approved by the EMA in August 2021. Approved for use in Japan in February 2022.
APCeden is an autologous monocyte-derived mature dendritic cell vaccine. It was approved in India in 2017 for the treatment of prostate cancer, ovarian cancer, colorectal cancer, and Non Small Cell Lung carcinoma.
BRISTOL MYERS SQUIBB
Breyanzi is a CAR T-cell therapy for adults with relapsed or refractory large B-cell lymphoma. It is approved by the US FDA for adult patients with relapsed or refractory diffuse large B-cell lymphoma (February 2021), and again for r/r large B-cell lymphoma as second line treatment (June 2022). It is approved by the European Commission for use in adult patients with r/r large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B (April 2022).
Carteyva is an autologous anti-CD19 CAR-T cell immunotherapy drug. It was approved by China’s NMPA in 2021 to treat adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
LEGEND BIOTECH & JANSSEN
Carvykti is a CAR-T cell therapy used for adult patients who have cancer of the bone marrow called multiple myeloma. It was approved in the U.S. in February of 2022 to treat relapsed or refractory multiple myeloma after four or more prior lines of therapy. It was also approved in the European Union in May of 2022 to treat relapsed or refractory multiple myeloma for adult patients who received at least three prior therapies.
A dendritic cell based vaccine intended to treat metastatic renal cell carcinoma for which nephrectomy can be performed. Approved in S. Korea in S. Korea in 2007.
A medicine for anticancer cell immunotherapy, made with T-lymphocyte incubated and activated after extraction from the blood of a patient. Conditionally approved in S. Korea in June 2007.
Kymriah is a CAR T-cell therapy product approved in the US for the treatment of acute lymphoblastic leukemia (ALL), chronic lymphoid leukemia and diffuse large B-cell lymphoma in patients up to 25 years of age, (US FDA, August 2017) the treatment of adult patients with relapse/refractory (r/r) large B-cell lymphoma, (US FDA, May 2018) and the treatment of adult patients with (r/r) follicular lymphoma. (US FDA, May 2022)
It also received EU marketing authorisation for these indications by the European Commission in August 2018, and by Health Canada in September 2018.
It was approved in Japan for the treatment of ALL in February 2019 and in Singapore in 2021.
Autologous Cellular Immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. BLA approved by the FDA in 2010.
KITE, A GILEAD COMPANY
Tecartus is a CAR-T therapy designed to treat mantle cell lymphoma. It was approved in the US in July 2020 and in the EU in December 2020.
KITE, A GILEAD COMPANY
Yescarta is a CAR T-cell therapy product indicated for the treatment of B cell malignancies such as non-Hodgkin lymphoma, acute lymphoblastic leukemia, mantle cell lymphoma, chronic lymphoid leukemia and diffuse large B-Cell lymphoma. Approved by U.S. FDA in October 2017. Approved by the EC in August 2018. Approved by Health Canada in February 2019. Approved in Japan in January 2021, and in China in June 2021.
Yescarta was approved for additional indications to treat follicular lymphoma (US FDA, March 2021) and r/r large B-cell lymphoma (US FDA, April 2022). It was also approved for additional indications to treat r/r follicular lymphoma (EU, June 2022) in the European Union.