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FDA Takes Action Against 14 Companies for Selling Illegal Cancer Treatments

The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.

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ASCO in Action: FDA Removes Risk Evaluation Management Strategies (REMS) for ESAs

On April 13, the U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy.

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Osimertinib (Tagrisso)

On March 30, 2017, the U.S. Food and Drug Administration granted regular approval to osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals, LP) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor […]

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Avelumab (Bavencio)

U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type […]

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Osimertinib (Tagrisso)

The U.S. Food and Drug Administration granted regular approval to osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals, LP) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

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Pembrolizumab (KEYTRUDA) for Classical Hodgkin Lymphoma

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA), Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.

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Ribociclib (KISQALI)

FDA approved ribociclib (KISQALI, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

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Xermelo (Telotristat Ethyl)

The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.

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Lenalidomide (Revlimid)

FDA approved lenalidomide (Revlimid, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.

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ASCO Policy Brief: FDA’s Regulation of Electronic Nicotine Delivery Systems and Tobacco Products

US Food and Drug Administration, US Department of Health and Human Services: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act: Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Final Rule. […]

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