fda-approvals-june-2019

New Cancer Treatments Approved in July

Selinexor, a New Treatment for Multiple Myeloma. The United States Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio®, Karyopharm Therapeutics) in combination with dexamethasone for patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies, including 2 proteasome inhibitors, 2 immunomodulatory agents, and a CD38-targeted monoclonal antibody. This approval […]

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fda-approvals-june-2019

FDA Issues Four Oncology/Hematology Approvals in June

Two New Indications for Pembrolizumab. The FDA extended the indication of the PD-1 inhibitor pembrolizumab (Keytruda®, Merck) to include its use as a first-line therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and for the treatment of patients with metastatic small cell lung cancer (SCLC) who have disease progression after at […]

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fda-approvals-june-2019

New Oncology and Hematology Indications Approved by FDA in May

PI3K Inhibitor Alpelisib for PIK3CA-mutated Advanced Breast Cancer. The phosphoinositide 3-kinase (PI3K) inhibitor alpelisib (Piqray®, Novartis Pharmaceuticals Corporation) was approved for use in combination with fulvestrant for treatment of postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer following progression on or after an endocrine containing regimen. To […]

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fda-approvals-june-2019

New FDA Cancer Indications Approved in March and April

Atezolizumab Becomes First Immunotherapy Approved for Breast Cancer. The United States Food and Drug Administration (FDA) granted accelerated approval to the combination of the PD-L1 inhibitor atezolizumab (Tecentriq®, Genentech) and nab-paclitaxel for treatment of patients with PD-L1-positive (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥1% of the tumor area) advanced triple-negative breast […]

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EMA Recommends Six New Oncology Indications in January and February

Since the beginning of the year, the European Medicines Agency (EMA) has issued six positive opinions recommending new indications for treatments in oncology, with a heavy focus on new treatments for lung cancer. These agents have previously been approved by the United States (US) Food and Drug Administration (FDA). Final approval in the European Union […]

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Four Oncology Indications Approved by FDA in January and February

Subcutaneous Trastuzumab Now Available in US for HER2- Positive Breast Cancer. The FDA approved trastuzumab and hyaluronidase-oysk injection (Herceptin Hylecta™, Genentech), a subcutaneous (SC) formulation of trastuzumab, for treatment of patients with HER2-positive breast cancer. Approval was based on results from the HannaH and SafeHER studies, which compared trastuzumab and hyaluronidase-oysk to standard intravenous (IV) […]

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FDA Wraps Up 2018 With Approval of Six New Anticancer Indications

2018 was another banner year for approvals by the United States Food and Drug Administration (FDA), with more than 50 new indications being awarded to immunotherapy, targeted therapies, chemotherapies, biosimilar antibodies, and diagnostic tests. Once again, immunotherapy took center stage with new indications for PD-1 and PD-L1 inhibitors across different tumor types. The most notable […]

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FDA Approved 11 New Cancer Treatments in October and November

Three New Therapies for Acute Myeloid Leukemia. The United States Food and Drug Administration (FDA) granted approval for three new agents for acute myeloid leukemia (AML) in November. Gilteritinib (Xospata®, Astellas), a FLT3-targeting tyrosine kinase inhibitor (TKI), was approved for use in adults with relapsed or refractory AML who have an FLT3 mutation, as detected […]

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FDA Approves Four New Oncology/Hematology Indications in September

New PD-1 Inhibitor for Cutaneous Squamous Cell Carcinoma. The United States Food and Drug Administration (FDA) approved a novel PD-1 inhibitor, cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals), for the treatment of patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiation. Approval was based on results from […]

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New FDA Approved Indications for Oncology and Hematology in August

First Chemotherapy-Free Treatment for Waldenströms Macroglobulinemia. The combination of the Bruton tyrosine kinase inhibitor ibrutinib (Ibruvica®, Abbvie) and the anti-CD20 monoclonal antibody rituximab (Rituxan®, Genentech) was approved by the United States Food and Drug Administration (FDA) for treatment of patients with Waldenströms macroglobulinemia (WM). Approval of this regimen was based on results from the phase […]

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