The Lynx Group

FDA Approvals, News & Updates

On March 1, 2019, the FDA accelerated the approval of atezolizumab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC.
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On March 18, 2019, atezolizumab (Tecentriq; Genentech) received a new indication for use with carboplatin and etoposide chemotherapy as first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC).
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On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin.
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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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  • 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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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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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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