2016 Oncology Pharmacy Guide to New FDA Approvals

The Journal of Hematology Oncology Pharmacy has published its first annual Oncology Pharmacy Guide to New FDA Approvals with the goal of providing pharmacists and other healthcare stakeholders with a comprehensive review of pharmaceuticals that were newly approved, or that received important new indications, by the US Food and Drug Administration (FDA) in the previous year. The current 2016 edition represents the first year of publication of this Guide by the Journal of Hematology Oncology Pharmacy.
The number of oncology trials seeking new indications for new and known agents is continuing to grow at a fevered pitch. The fruition of this work is now being realized; in the past 12 months, there have been 36 hematology/oncology drug approvals, 18 of which involved new drug entities.
The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories.
Lung cancer is the second most common cancer in the United States. In 2015, an estimated 221,200 new cases of lung cancer were diagnosed, representing 13.3% of all new cancer cases. Furthermore, lung cancer is the leading cause of cancer mortality in men and women, responsible for 27% of all cancer deaths, and claiming more lives than breast, colon, prostate, and ovarian cancers combined.
Chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (NHL) are common hematologic malignancies that represent a significant burden to patients and to the healthcare system. In light of the morbidity, mortality, and quality-of-life challenges associated with CLL and NHL, there is a marked need for additional therapeutic options for patients with these malignancies.
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to the disease.
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to the disease.
Waldenström’s macroglobulinemia (WM), also known as lymphoplasmacytic lymphoma, is an indolent subtype of B-cell non-Hodgkin lymphoma. WM is characterized by malignant B-cells that overproduce the abnormal monoclonal protein known as immunoglobulin (Ig) M or macroglobulin.
Melanoma represents the most dangerous form of skin cancer. According to recent data, the 5-year relative survival rate for Americans with distant melanoma is only 17%. The National Cancer Institute estimated that in 2015 there were 73,870 new cases of skin melanoma and more than 9900 patients died from this disease. In the United States, the total estimated national expenditures for the treatment of melanoma reached $2.8 billion in 2015.
Lung cancer is the leading cause of cancer-related mortality in the United States among men and women. The most common type of the disease, non–small-cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases. NSCLC comprises several disease histologies, including adenocarcinoma, squamous-cell carcinoma, nonsquamous carcinoma, large-cell anaplastic carcinoma, and adenosquamous carcinoma.
Considering its high financial and personal costs, colorectal cancer continues to be a major public health problem in the United States and around the world. Colorectal cancer is the second leading cause of cancer death in the United States when data are combined for men and women.
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to the disease.
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to the disease.
Lung cancer is the second most common cancer in the United States. In 2015, an estimated 221,200 new cases of lung cancer were diagnosed, representing 13.3% of all new cancer cases.
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to multiple myeloma in the same year.
A critical part of care planning for patients with cancer is the prevention and management of chemotherapy-induced nausea and vomiting (CINV), one of the most feared side effects of chemotherapy. Overall, 70% to 80% of patients with cancer experience CINV in the absence of appropriate CINV prophylaxis.
Colony-stimulating factors (CSFs) are endogenous glycoproteins that regulate the production and the functioning of infection-protective granulocytes and macrophages. Overall, 2 types of recombinant CSF drugs—granulocyte CSF (filgrastim, pegfilgrastim) and granulocyte-macrophage CSF (sargramostim)—have been prescribed for more than 20 years to stimulate neutrophils and macrophages, primarily in patients with cancer who are undergoing treatment with cytotoxic chemotherapy.
The year 2015 marked a noteworthy 12-month period for oncology drugs approved by the US Food and Drug Administration (FDA). The Center for Drug Evaluation and Research, which reviews the approval of antibodies and small molecules, approved a total of 45 new drugs in 2015; 15 of which are indicated for the treatment of cancer.

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