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FDAFDA Approves First Drug for Cancers with a High Tumor Mutational Burden
The US Food and Drug Administration (FDA) has expanded the approval of the immunotherapy drug pembrolizumab (Keytruda) to include any cancer with a high tumor mutational burden (TMB-H).
FDA Approves Trodelvy (Sacituzumab govitecan-hziy) for Triple Negative Breast Cancer
The US Food and Drug Administration (FDA) approved a new type of therapy for triple-negative breast cancer that has spread to other parts of the body and hasn’t responded to other treatments.
FDA Approves Pemazyre (Pemigatinib) for Bile Duct Cancer
The US Food and Drug Administration (FDA) approved the first targeted therapy for bile duct cancer. Pemazyre (pemigatinib) is for adults whose cancer has grown after at least one previous chemotherapy treatment and whose tumors have a mutation in the FGFR2 gene.
FDA Approves Jelmyto (Mitomycin gel) for Urothelial Cancer
The US Food and Drug Administration (FDA) approved Jelmyto (mitomycin gel) for a type of urothelial cancer, which is a cancer of the lining of the urinary system.
FDA Approves Tazverik (Tazemetostat) for Epithelioid Sarcoma
The US Food and Drug Administration (FDA) has approved Tazverik (tazemetostat) to treat adults and children 16 and older with epithelioid sarcoma, a rare cancer which accounts for less than 1% of all soft tissue sarcomas.
FDA Approves Ayvakit (Avapritinib) for GIST
The US Food and Drug Administration (FDA) has approved Ayvakit (avapritinib) to treat people with advanced cases of gastrointestinal stromal tumor (GIST) that have a certain genetic mutation.
FDA Approves Padcev (Enfortumab vedotin-ejfv) for Bladder Cancer
The US Food and Drug Administration (FDA) has approved a new type of drug for certain people with bladder cancer.
2019 in Review: New Cancer Drug Approvals
In 2019, the FDA approved several new drug treatments for different cancer types. Here are the stories that made headlines on cancer.org this year.