FDA Approves First Use for an Anticancer Therapeutic Based on Tumor Biomarker, Not Tumor Origin

Tuesday marked a milestone for the oncology community: The U.S. Food and Drug Administration (FDA) announced its first approval of an anticancer therapeutic for use based on whether a patient has a tumor with certain biomarkers and not where in the body the tumor originated.

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FDA Approves Fourth Immune Checkpoint Inhibitor for Bladder Cancer

This time last year there were no immune checkpoint inhibitors approved by the U.S. Food and Drug Administration (FDA) for treating the most common form of bladder cancer—urothelial carcinoma. The approval of avelumab (Bavencio) earlier this week means there are now four of these revolutionary immunotherapeutics in the armamentarium.

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FDA Approves Fourth ALK Inhibitor for Lung Cancer

Last week, a flurry of U.S. Food and Drug Administration (FDA) oncology approvals concluded with the approval of the molecularly targeted therapeutic brigatinib (Alunbrig) for treating certain patients with metastatic non–small cell lung cancer (NSCLC).

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New Immune Checkpoint Inhibitor Approved for Bladder Cancer

Earlier this week, the U.S. Food and Drug Administration (FDA) announced that it had approved a new immune checkpoint inhibitor, durvalumab (Imfinzi), for the treatment of certain patients with the most common form of bladder cancer—urothelial carcinoma.

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AACR Annual Meeting 2017: Most Merkel Cell Carcinoma Responses to the Newly FDA-Approved Avelumab Expected to Last More than a Year

T cells and antibodies

On March 23, the U.S. Food and Drug Administration announced the first-ever approval of a treatment for patients with a rare, aggressive form of skin cancer called Merkel cell carcinoma. The treatment, the immunotherapeutic avelumab (Bavencio), was approved based on data from the JAVELIN Merkel 200 phase II clinical trial.

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FDA Approves New PARP Inhibitor for Ovarian Cancer

Earlier this week, the U.S. Food and Drug Administration (FDA) approved the molecularly targeted therapeutic niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers that are responding to platinum-based chemotherapy.

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