Budgets are political documents. When we look at a spreadsheet, for many of us the numbers are jumbles and the lines begin to blur. But reviewed closely, budgets are the prioritization of federal policy.

On June 6, 2017, the U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan, NX Development Corp.) as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

Since the campaign trail prior to the presidential election, Donald Trump has been drawing focus to the issue of high drug prices in the United States. In an effort combat the pricing issues, Trump appointed U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, who recently announced the creation of the “drug competition action plan.” The plan would reduce the high cost of drugs in U.S. healthcare market by increasing the efficiency of approving generic medications of name-brand drugs.

On May 26, 2017, the U.S. Food and Drug Administration granted regular approval to ceritinib (Zykadia^®, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda^®, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

As legislation to repeal the Affordable Care Act works its way into the Senate, a new working group is attempting tackle the issue through tax breaks that would potentially ease healthcare costs. However, when the working group was formed, some Republican Senators were left out of the discussion—namely women senators in the GOP. After receiving flack for the decision, the working group officially opened its doors to anyone in the Republican convention.

Disparities continue to create a wide gap in health in the United States. Many factors can contribute to a person’s health, and we still have much to learn about the issue. The U.S. Food and Drug Administration (FDA) has announced it will be dedicating research funding to find out more about how lifestyle impacts health.

On May 18, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (Keytruda^®, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

On May 10, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer.

On May 9, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

After former President Obama’s surgeon general was asked to resign by the Trump administration, the White House appointed Rear Admiral Sylvia Trent-Adams, PhD, RN, FAAN, as acting surgeon general.

On May 1, 2017, the U.S. Food and Drug Administration granted accelerated approval to durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.  

On April 28, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.

On April 27, 2017, the U.S. Food and Drug Administration (FDA) expanded the indications of regorafenib to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

On April 25, 2017, the U.S. Food and Drug Administration (FDA) issued warning letters to 14 companies that were selling fraudulently marketed products claiming to prevent, diagnose, treat, or cure cancer. In total, the companies produced more than 65 products that have been sold in the United States without FDA approval.

As the first 100 days of the Trump administration ends, the White House is still pressing Congress to revisit healthcare legislation—one of Trump’s main campaign promises.

The U.S. Food and Drug Administration (FDA) has permitted marketing of the Philips IntelliSite Pathology Solution (PIPS, Philips Medical Systems Nederland B.V.), as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue.

On April 13, 2017, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy.

The U.S. Food and Drug Administration has granted marketing authorization to ipsogen JAK2 RGQ PCR Kit, manufactured by Qiagen GmbH., to detect mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV).

On March 31, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to palbociclib for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women.

On March 30, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to osimertinib for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

The end of 2016 proved to be a busy and exciting time for cancer breakthroughs, seeing eight new U.S. Food and Drug Administration (FDA) approvals for immunotherapy and biotherapy. Following is a summary of cancer-related FDA approvals in the last quarter of 2016, indications for treatment, and associated clinical implications.

On March 27, 2017, the U.S. Food and Drug Administration (FDA) approved niraparib, a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

On March 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.

The U.S. Food and Drug Administration (FDA) recently announced, through the Office of Health and Constituent Affairs, that it has established the Oncology Center of Excellence (OCE). Longtime FDA official, Richard Pazdur, MD, has been named to lead the division as its first director. The OCE will make oncology “the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers,” according to the FDA.

On February 22, 2017, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid^®, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.