As oncology diagnoses increase across the globe, immuno-oncology therapies have emerged as a novel treatment category, outside of chemotherapy and radiotherapy, that can help combat aggressive forms of cancer. Against this backdrop, 2022 saw a record number of immuno-oncology approvals with 10 new innovative drugs being approved, finds GlobalData, a leading data and analytics company.

Quentin Horgan, Associate Director at GlobalData, comments: “The first officially recognized immuno-oncology therapy was Bristol-Myers Squibb’s Yervoy, a monoclonal antibody that functioned as an immune checkpoint inhibitor and was approved in 2011 by the FDA for metastatic melanoma. Since then, the number of approved innovator immuno-oncology therapies (immunotherapies) has been on the rise, with a 150% increase between 2014 and 2022.”

The steady rise in the number of approvals has been driven by the success of these therapies, with immuno-oncology therapy Keytruda forecast to become the highest-selling drug in 2023. Between 2020 and 2021, the number of approvals increased by over 300%. 2022 saw a further 11% increase giving it the record number of approvals.

Quentin continues: “This record-breaking cohort included therapies such as Carvykti by Johnson & Johnson, a gene-modified cell therapy that was approved for refractory multiple myeloma, and Hansizhuang by Shanghai Henlius Biotech, a monoclonal antibody approved for lung cancer and other solid tumors.”

The large increase in the number of immuno-oncology therapy approvals over the last two years highlights their significance, especially in light of the fact that the COVID-19 pandemic led to delays in the review and approval of multiple drugs.

Quentin concludes: “If this peak in the number of approvals continues, it may mean that we see a shift in the types of oncology therapies making it to the market, with immuno-oncology therapies making up a greater share. However, with only three therapies approved in the first half of 2023, it remains to be seen if 2022’s high number of approvals will be matched.”