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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EMA Positive Opinions in July For New Anticancer Therapies in Europe

On 26 July, the European Medicines Agency (EMA) issued several positive opinions recommending the approval of new agents for anticancer indications in Europe. Durvalumab, First Immunotherapy for Locally Advanced NSCLC. The immune checkpoint inhibitor durvalumab (Imfinzi®, AstraZeneca) received a positive opinion for treatment of PD-L1-positive (>1%) patients with locally advanced unresectable non-small cell lung cancer […]

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New FDA-Approved Cancer Treatments in July

• Nivolumab and Ipilimumab Combo Approved for MSI-High Colorectal Cancer. The United States Food and Drug Administration (FDA) expanded the indication of ipilimumab (Yervoy®, Bristol-Myers Squibb) to include use in combination with nivolumab in patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) who have progressed following treatment with […]

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Multiple Oncology/Hematology Indications Recommended by EMA in June

On 28 June 2018, the European Medicines Agency (EMA) issued positive opinions for approval of several new anticancer therapies in Europe.   Neratinib for Extended Adjuvant Therapy in HER2-Positive, HR-Positive Early Breast Cancer. The EMA granted a positive opinion to pan-HER targeted tyrosine kinase inhibitor neratinib (Nerlynx®, Puma) for use as an extended adjuvant therapy […]

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FDA Expands Arsenal of Oncology/Hematology Medicines in June

New BRAF/MEK Inhibitor Combo in Melanoma. The Food and Drug Administration (FDA) approved the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib (Braftovi® and Mektovi®, Array BioPharma Inc) for the treatment of patients with metastatic melanoma with a BRAF V600E or V600K mutation. This approval was based on results from the phase […]

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