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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Important New FDA Approvals in May for Patients With Cancer

Combo Dabrafenib/Trametinib for BRAF-Mutated Thyroid Cancer. The United States Food and Drug Administration (FDA) expanded the indication of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib (Tafinlar® and Mekinist®, Novartis) in combination to include use in patients with BRAFV600E-mutated anaplastic thyroid cancer. This approval was based on results from a multicohort, nonrandomized, phase II […]

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EMA Positive Opinions to Expand Oncology Treatment Options in Europe

In March and April 2018, the European Medicines Agency (EMA) issued several positive opinions that recommended approval or expanded indications for oncology/hematology agents. All but one of these agents has been previously approved by the US Food and Drug Administration (FDA) for similar indications. Osimertinib for First-Line EGFR-Mutant NSCLC. The EMA granted a positive opinion […]

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Five FDA Approvals for Oncology Agents in April

Adjuvant Dabrafenib/Trametinib for BRAF-Positive Melanoma. The combination of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib (Tafinlar® and Mekinist®, Novartis Pharmaceuticals) was approved for use as adjuvant therapy in patients with BRAF V600E or V600K-positive stage III melanoma following complete resection. This decision was based on results from the phase III COMBI-AD study, which […]

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FDA Approves Three Agents for Hematologic Malignancies in March

Blinatumomab Received Accelerated Approval for Minimal Residual Disease–Positive ALL. On 29 March the United States Food and Drug Administration (FDA) expanded the indication of the CD19/CD3 bispecific T-cell engager blinatumomab (Blincyto®, Amgen) to include adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission (CR) with minimal residual […]

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