FDA Immunotherapy Approvals in 2022

As drug development in cancer immunotherapy has accelerated, the U.S. Food and Drug Administration has approved several new drugs, treatment regimens, combination therapies, and diagnostic tests for this new pillar of cancer treatment. Here is a running list of approvals for immunotherapy drugs and related tests in 2022: 

On January 26, it approved the bispecific fusion protein tebentafusp-tebn (KIMMTRAK) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

On February 21, it approved the companion diagnostic test FoundationOne CDx to identify patients with microsatellite instability high (MSI-H) solid tumors who may be candidates for immunotherapy.

On February 28, it approved the BCMA-targeted CAR T cell therapy ciltacabtagene autoleucel (Carvykti) for the treatment of a subset of patients with multiple myeloma.

On March 4, it approved the PD-1 checkpoint inhibitor nivolumab (Opdivo) plus chemotherapy pre-surgery for a subset of lung cancer patients.

On March 18, it approved a new combination of nivolumab and the LAG-3 checkpoint inhibitor relatlimab (Opdualag) for a subset of patients with melanoma. This is the first approval of a LAG-3 checkpoint inhibitor and the first approval of a new checkpoint inhibitor since 2014.

On March 21, it approved the PD-1 checkpoint inhibitor pembrolizumab (Keytruda) for a subset of patients with endometrial carcinoma that is microsatellite instability high or mismatch repair deficient.

On April 1, it approved axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. 

On April 18, it approved the third biosimilar for the monoclonal antibody bevacizumab—bevacizumab-maly (Alymsys)—for the treatment of subsets of patients with colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian cancer.

On May 27, it approved two immunotherapy-based regimens for first-line treatment of advanced esophageal squamous cell carcinoma: nivolumab plus chemotherapy and nivolumab plus ipilimumab (Yervoy). 

On May 28, it granted accelerated approval to tisagenlecleucel (Kymriah) for a subset of patients with relapsed or refractory follicular lymphoma. 

We will update this article as new approvals are made this year. 

Check our timeline of approvals for active immunotherapies 

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