On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved a lower dose of cabazitaxel (20 mg/m² every 3 weeks) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.  Cabazitaxel (25 mg/m² every 3 weeks) was approved for this indication in 2010.

On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved Mvasi (bevacizumab-awwb, Amgen Inc.) as a biosimilar to Avastin (bevacizumab, Genentech Inc.). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients.

On August 31, 2017, based on data from two recently halted clinical trials, the U.S. Food and Drug Administration (FDA) is issuing a statement to inform the public, healthcare professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.

On August 30, 2017, the U.S. Food and Drug Administration granted regular approval to tisagenlecleucel for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.

In June 2017, the U.S. Food and Drug Administration (FDA) approved Rituxan Hycela, a combination of rituximab and hyaluronidase, for subcutaneous administration in the treatment of follicular lymphoma and diffuse large B-cell lymphoma as well as chronic lymphocytic leukemia (CLL). This agent affords the same clinical benefit as IV rituximab, but in much less time. With this approval comes many questions about which patients are appropriate and administration considerations for subcutaneous rituximab and hyaluronidase.

On August 17, 2017, the U.S. Food and Drug Administration granted regular approval to olaparib tablets 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.

On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

A new bill passed in the U.S. Senate last week will provide measures to ensure that drug companies are developing treatments for children with cancer. The RACE for Children Act is part of the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017, which aims to speed up the approval process for new treatments and medical devices and is expected to be signed into law by President Trump.

On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos™, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.

On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica^®, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.

High-ventilation (light) cigarettes have no health benefits to smokers and have likely contributed to increased incidence of adenocarcinoma deep in the lungs, according to the results of a new study published in the Journal of the National Cancer Institute.

On August 1, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

On July 31, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for the treatment of patients 12 years and older with mismatch repair deficient and microsatellite instability high metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

On July 17, 2017, the U.S. Food and Drug Administration approved neratinib (Nerlynx™, Puma Biotechnology, Inc.) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

On July 7, 2017, the U.S. Food and Drug Administration (FDA) approved L-glutamine oral powder for oral administration to reduce the acute complications of sickle cell disease in adult and pediatric patients five years and older.

On June 29, 2017, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel (Illumina, Inc.), a next generation sequencing (NGS) test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer (mCRC). The test is used to aid in the identification of patients who may be eligible for treatment with panitumumab (Vectibix^®, Amgen, Inc.).

On June 22, 2017, Republican senators unveiled their version of the bill repeal and replacement bill for the Affordable Care Act, known to most as Obamacare. The Senate bill looks similar to the House-backed healthcare bill passed in May 2017. Central to the Senate’s bill are proposed cuts to Medicaid expansion, along with eliminating a net investment income tax that impacts higher earners. The proposed bill provides more tax subsidies for lower-income individuals than its sister bill from the House of Representatives, but it’s still expected to raise costs for poorer Americans.

On June 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

On June 22, 2017, the U.S. Food and Drug Administration granted (FDA) regular approvals to dabrafenib and trametinib (Taflinar^® and Mekinist^®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.

On June 22, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

Oncology clinicians can expect to continue to see new targeted and immunotherapy drugs emerge as clinically approved agents in the fight against cancer. Five cancer-related U.S. Food and Drug Administration (FDA) approvals occurred in the first quarter of 2017; following are their indications for treatment and associated clinical implications. You’ll recognize that some of the agents were already FDA approved for other uses, but as clinical trials continue and new data emerge, clinical use is expanding to other disease sites and indications.

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.

On March 14, 2017, The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA^®, Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.