FDA Approves New Lung Cancer Treatment and First Next-Gen Companion Diagnostic

Hot on the heels of the FDA’s landmark approval of an anticancer therapeutic for use based on whether a patient has a tumor with certain biomarkers, rather than a tumor originating at a certain anatomic site, the agency approved the first companion diagnostic that can detect mutations in multiple genes in a single test.

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AACR In the News

The American Association for Cancer Research (AACR) has appeared in numerous publications lately, showcasing the breadth of our mission to prevent and cure all cancer. News stories have featured scientific research, interviews with AACR leadership, and a first-person account of cancer’s financial toll.

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A Targeted Therapy Next in Line for Biomarker-based Cancer Drug Approval?

recent data suggest that there is another potential contender for a biomarker-based FDA approval: a targeted therapeutic called larotrectinib (LOXO-101), which showed promising results in adults and children with a variety of cancer types, all of which had one thing in common – fusions involving the gene TRK.

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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 Guidelines Suggest Individualized Approach to Prostate Cancer Screening

The U.S. Preventive Services Task Force (USPSTF) released draft recommendations April 11 suggesting that doctors inform men ages 55 to 69 of the potential benefits and harms of prostate-specific antigen (PSA) blood testing to screen for prostate cancer. The draft says the decision to be screened is an individual one that should be made after consulting with a physician.

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