2017 was a record-setting year for FDA approvals in oncology

The US Food and Drug Administration (FDA) had a record number of approvals in the field of hematology/oncology in 2017. The approvals included new drugs, expanded indications, new devices, and diagnostic tests.

Immunotherapy was well represented. New indications were announced for checkpoint inhibitors, including for pretreated metastatic cancers with high levels of microsatellite instability and cancers with limited treatment options, such as gastric cancer, hepatocellular cancer, and Merkel cell carcinoma. 

Two biosimilar monoclonal antibodies also arrived in the United States, fanning hopes that they will reduce costs associated with treatment.

Highlights of last year’s approvals include:

Breast cancer

• Pertuzumab in combination with trastuzumab and chemotherapy as an adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
• Abemaciclib in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
• Neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
• Ribociclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

Ovarian cancer

• Olaparib tablets and niraparib for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Gastrointestinal cancer

• Pembrolizumab for recurrent locally advanced or metastatic, gastric, or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test.

Melanoma

• Nivolumab for the adjuvant treatment of melanoma with involvement of lymph nodes or for patients with metastatic disease who have undergone complete resection.

Renal cell carcinoma (RCC)

• Sunitinib malate for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
• Cabozantinib for treatment of advanced RCC.

Chronic myelogenous leukemia (CML)

• Bosutinib was granted accelerated approval for treatment of newly diagnosed chronic phase Philadelphia chromosome positive (Ph+) CML.
• Dasatinib for the treatment of pediatric patients with Ph+ CML in the chronic phase.

Merkel cell carcinoma (MCC)

• Avelumab for the treatment of patients 12 years and older with metastatic MCC. Avelumab is a programmed death-ligand 1 blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.

Hepatocellular carcinoma (HCC)

• Nivolumab for the treatment of HCC in patients who have been previously treated with sorafenib.

Lung cancer

• Alectinib for treatment of anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, as detected by an FDA-approved test.

Biosimilars

• Bevacizumab-awwb, the first biosimilar approved in the United States for the treatment of cancer.
• Trastuzumab-dkst for the treatment of HER2-overexpressing breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).