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# 2018 Cancer Drug Approvals Reviewed
- URL: https://www.fdaweb.com/2018-cancer-drug-approvals-reviewed/
- Published: 2019-02-05T12:00:00.000Z
- Updated: 2026-09-15T01:00:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143303

FDA last year approved 19 new drug and biologic applications, 38 supplemental drug and biologic applications, and four biosimilar applications in oncology. “These advances in anticancer therapy included a landmark approval of the first histology-agnostic, biomarker-defined new molecular entity and approvals based on real-time data review and novel endpoints, such as minimal residual disease rate and metastasis-free survival,” [write](https://www.nature.com/articles/s41571-019-0170-z?ref=fdaweb.com) **Gideon Blumenthal** and **Richard Pazdur** from the FDA Oncology Center of Excellence in *Nature Review Clinical Oncology* (purchase or subscription required).

The 19 new drug and biologic applications were for treating various types of cancer, including advanced forms of leukemia, lymphoma, non-small cell lung cancer, breast cancer, cutaneous squamous cell carcinoma, neuroendocrine tumors, melanoma, and prostate cancer, the article says. In particular, it says, accelerated approval of the first histology-agnostic new molecular entity application will be viewed as an important milestone in oncology drug development.