Web Exclusives

Web Exclusives — May 7, 2019
On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
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Web Exclusives — April 16, 2019
  • Keytruda Receives Expanded Indication for First-Line Treatment of Non–Small-Cell Lung Cancer
  • FDA Changes Recommended Contraception Period Following Soltamox Therapy
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Web Exclusives — April 5, 2019
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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Web Exclusives — April 1, 2019
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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Web Exclusives — March 15, 2019
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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Web Exclusives — March 8, 2019
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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Web Exclusives — February 27, 2019
A dizzying array of new chimeric antigen receptor (CAR) T-cell therapies targeting the B-cell maturation antigen (BCMA) designed specifically for the treatment of multiple myeloma was presented at the 2018 American Society of Hematology (ASH) annual meeting. BCMA-targeted CAR T-cell therapies are designed to improve T-cell persistence, depth of response, and tolerability. Response rates reported at ASH 2018 range from 70% to 100%, depending on the patient population and the use of previous regimens.
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