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FDA Approvals, News & Updates
FDA Approves First Hormonal-Based Therapy for Men with Advanced or Metastatic Breast Cancer
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On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
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Proposed Landmark Policy Changes to Modernize Mammography and Raise Breast Density Awareness
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On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
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FDA Approves Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer
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For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq.
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FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
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On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form of breast cancer.
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March 08, 2019 - FDA Approvals, News & Updates
FDA Approvals, News & Updates
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Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.
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FDA Approves Pembrolizumab for Treatment of Advanced Melanoma
FDA Approvals, News & Updates
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On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first FDA approval in the adjuvant setting.
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FDA Approves Split-Dosing Regimen for Daratumumab in Patients with Multiple Myeloma
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Multiple Myeloma
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Hematologic Malignancies
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On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion.
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Conquer Cancer Foundation of ASCO & Swim Across America Team Up To Create Young Investigator Award
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Swim Across America is supporting the American Society of Clinical Oncology (ASCO) and ASCO’s Conquer Cancer Foundation with the creation of the Conquer Cancer Foundation of ASCO—Swim Across America Young Investigator Award (YIA).
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February 8, 2019 - FDA Approvals, News & Updates
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February 1, 2019 - FDA Approvals, News & Updates
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