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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EMA Recommendations for Oncology/Hematology Approval in February

On 22 February, the European Medicines Agency (EMA) issued positive opinions for granting marketing authorization for four agents in oncology and hematology. All of these agents have previously been approved for similar indications by the US Food and Drug Administration (FDA). Gemtuzumab Ozogamicin as First-Line Therapy for AML. A CD-33-targeting antibody-drug conjugate, gemtuzuamb ozogamicin (Mylotarg™, […]

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Four Oncology Agents Approved in the United States in February

Abemaciclib Indication Expanded to Include Previously Untreated Metastatic Breast Cancer. Abemaciclib (Verzenio®, Eli Lilly and Company), a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, was approved for use in combination with an aromatase inhibitor (AI) for first-line treatment of postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer. This Food […]

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FDA Approved Three New Oncology Indications in January

Olaparib Given Greenlight in BRCA-Mutated Breast Cancer. The poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza®, AstraZeneca) was approved for use in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy and, if appropriate, a hormonal therapy. This approval was based on results from the phase III OlympiAD trial, in […]

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A Record Number of Anticancer Indications Approved by the FDA in 2017

2017 was an extremely busy year for the US Food and Drug Administration (FDA) in the field of oncology and hematology. Including new drug approvals, expanded indications, new devices, and diagnostic tests, there were more than 50 approvals in 2017. Immunotherapy once again was the shining star, with a number of new indications for immune […]

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FDA Extends Five Indications of Anticancer Agents in November

In November 2017, the United States Food and Drug Administration (FDA) issued new indications for five previously approved anticancer agents. Adjuvant Sunitinib Approved in Renal Cell Carcinoma. The FDA expanded the indication of sunitinib (Sutent®, Pfizer) in renal cell carcinoma (RCC) to include use as adjuvant therapy following nephrectomy in patients at high risk for […]

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EMA Gives Green Light to Three Oncology Agents in October

On 12 October 2017, the European Medicines Agency (EMA) issued positive opinions supporting approval of expanded indications for three oncology treatments. Alectinib for First-Line Therapy of ALK-Rearranged Lung Adenocarcinoma. The anaplastic lymphoma kinase (ALK) inhibitor alectinib (Alecensa®, Roche) was previously approved only for ALK-positive patients who had progressed on crizotinib. The EMA recommendation to extend […]

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