How the FDA Provides New Approaches to Old Problems
Every quadrennial presidential cycle, as the newly elected leader moves into the Oval Office, he selects a core group of advisors who are philosophically aligned and eager to make changes in the federal government’s process. However, this is often not as simple as the new administration believes.
FDA Approves Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma
On November 16, 2017, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent, Pfizer Inc.) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.
FDA Approves Obinutuzumab for Previously Untreated Follicular Lymphoma
On November 16, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to obinutuzumab (Gazyva®, Genentech, Inc.) in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL).
FDA Approves Emicizumab-Kxwh for Bleeding in Patients With Hemophilia A With Factor VIII Inhibitors
On November 16, 2017, the U.S. Food and Drug Administration (FDA) approved emicizumab-kxwh (Hemlibra®, Genentech, Inc.) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
FDA Approves Dasatinib for Pediatric Patients With CML
On November 9, 2017, U.S. the Food and Drug Administration (FDA) granted regular approval to dasatinib (Sprycel®, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.
FDA Approves Brentuximab Vedotin for Primary Cutaneous Anaplastic Large Cell Lymphoma, CD30-Expressing Mycosis Fungoides
On November 9, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adetris®, Seattle Genetics, Inc.) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
FDA Funds Research Into Health Disparities
A wide gap in health disparities continues to exist in the United States, affecting countless underserved and underrepresented Americans. Despite some focus on education, assistance, and outreach, pockets of U.S. citizens are still facing healthcare challenges because of their race, socioeconomic status, location, or other disparities. Because many different factors can contribute to a person’s health, the U.S. Food and Drug Administration (FDA) is dedicating research funding to learn more about how people’s life situations have an impact on their overall health.
FDA Approves Alectinib for ALK-Positive, Advanced, Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
FDA Approves Vemurafenib for Erdheim-Chester Disease
On November 6, 2017, the U.S. Food and Drug Administration granted regular approval to vemurafenib (Zelboraf®) for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.
Commissioner Gottlieb Comments on Nicotine Regulation
In May 2017, Scott Gottlieb, MD, was named as the newest U.S. Food and Drug Administration (FDA) commissioner. He’s since shown a commitment to regulating tobacco and nicotine delivery systems—such as e-cigarettes—especially when it comes to children. In one of his public forums, Gottlieb spoke about the FDA’s commitment to continued oversight and regulation of these products and their distribution, a stance that’s drawn support from the medical community.
FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma
On October 31, 2017, the Food and Drug Administration (FDA) granted accelerated approval to acalabrutinib (Calquence™, AstraZeneca Pharmaceuticals, Inc.) for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
FDA Approves Rolapitant IV for CINV
On October 25, 2017, the U.S. Food and Drug Administration (FDA) approved the use of rolapitant (Varubi®) IV in combination with other antiemetic agents for adults experiencing delayed chemotherapy therapy-induced nausea and vomiting (CINV). Rolapitant through oral administration had been approved through the FDA in September 2015. The new IV administration route is expected to offer the same results at a lower cost to patients with CINV.
What Oncology Nurses Need to Know About Subcutaneous Rituxan Hycela
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.
FDA Update on Nerlynx™ (Neratinib) Tablets
On July 17, 2017, the U.S. Food and Drug Administration (FDA) approved Nerlynx™ (neratinib) tablets, an oral kinase inhibitor, for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2-positive (HER2+) breast cancer, following adjuvant trastuzumab-based therapy.
FDA Approves Axicabtagene Ciloleucel for Large B-cell Lymphoma
On October 18, 2017, the Food and Drug Administration (FDA) granted regular approval to axicabtagene ciloleucel (Yescarta™) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
FDA Simplifies IRB Requirements for Individual Patient Expanded Access
On October 3, 2017, the U.S. Food and Drug Administration (FDA) announced updates to three final guidance documents, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB) review requirements for physicians seeking to treat an individual patient with an investigational drug under expanded access. The updates allow for a waiver of the requirement for review and approval at a convened IRB meeting if the physician instead obtains concurrence by the IRB chairperson (or a designated IRB member) before treatment use begins.
FDA Approves Abemaciclib For HR-Positive, HER2-Negative Breast Cancer
On September 28, 2017, the U.S. Food and Drug Administration approved abemaciclib in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
Recent Drug Approvals Offer New Options for Non-Small Cell Lung Cancer, Genitourinary Cancers, and More
Cancer treatment options continue to multiply as 2017 continues, with the U.S. Food and Drug Administration (FDA) granting multiple new drug approvals and broadening indications for others. Oncology clinicians and nurses are challenged with staying abreast of treatment option expansions and navigating the dynamic field of cancer treatment to effectively navigate their patients through the treatment trajectory, educating on vital points relative to treatment, minimizing morbidity and mortality, and optimizing quality of life. Following is an overview of the latest approvals for the second quarter of 2017.
FDA Grants Accelerated Approval to Nivolumab for HCC
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
On September 22, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Ketruda®) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.
FDA Approves Lower Dose of Cabazitaxel for Prostate Cancer
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.
FDA Grants Accelerated Approval to Copanlisib for Relapsed Follicular Lymphoma
On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.
FDA Approves First Biosimilar for Cancer Treatment
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.
FDA Approves Gemtuzumab Ozogamicin for CD33-Positive AML
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.
FDA Halts Two Clinical Trials Evaluating Pembrolizumab in Patients With Multiple Myeloma
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.
FDA Approves Tisagenlecleucel for B-cell ALL, Tocilizumab for Cytokine Release Syndrome
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.
FDA Approves Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
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.
FDA Approves Inotuzumab Ozogamicin for Relapsed, Refractory B-Cell Precursor ALL
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.
Senate Passes Bill to Focus on Childhood Cancer Treatments
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.
FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Patients With AML
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.
FDA Expands Ibrutinib Indications to Chronic GVHD
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.
“Light” Cigarettes to Blame for Rise in Lung Adenocarcinoma
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.
FDA Approves Enasidenib for Adults With Relapsed or Refractory AML With an IDH2 Mutation
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.
FDA Grants Nivolumab Accelerated Approval for Colorectal Cancer
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.
FDA Approves Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
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.
FDA Approves L-Glutamine Powder for the Treatment of Sickle Cell Disease
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.
FDA Approves First Single NGS Test to Detect Multiple RAS Mutations
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.).
Senate Republicans Unveil Replacement Healthcare Bill; Single-Payer Healthcare System Would Have High Price Tag; FDA Commissioner Comments on 2016 Youth Tobacco Survey Results
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.
FDA Approves Betrixaban for Extended Duration Prophylaxis of Venous Thromboembolism
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.
FDA Approves Dabrafenib and Trametinib Combination for Metastatic NSCLC with BRAF V600E Mutation
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.
FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of FL, DLBCL, and CLL
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.
Recent FDA Approvals Continue to Focus on Targeted and Immunotherapy
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.
FDA Approves ALA Optical Imaging Agent for Gliomas
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.
FDA Commissioner Aims to Address Drug Pricing Issues; House Republicans Propose 12-Bill Appropriations Omnibus; Adults Don’t Recognize Harm of Vaping Around Kids
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.
FDA Broadens Ceritinib Indication to Previously Untreated ALK-Positive Metastatic NSCLC
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.
FDA Grants Accelerated Approval to Pembrolizumab for First Tissue/Site Agnostic Indication
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.
Senate Obamacare Working Group Expands; Gottlieb, MD, Named FDA Commissioner; Bipartisan Commitment to Healthcare Delivery System Reform
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.
FDA Funds Research Into Health Disparities
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.