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Showing 2051 - 2100FDA Approves Abiraterone Acetate in Combination With Prednisone for High-Risk Metastatic Castration-Sensitive Prostate Cancer
On February 7, 2018, the U.S. Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer. The FDA initially approved abiraterone acetate with prednisone in 2011 for patients with...
ASCO Offers Oncology Perspective on 2018 Federal Agency Activities and Rulemaking
AS 2017 came to a close, ASCO offered the oncology community’s perspective to federal agencies—including the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA)—in response to open comment periods before rules and plans for 2018 and 2019 programs and ...
ASCO Names Adoptive Cell Immunotherapy as Cancer Advance of the Year
In Clinical Cancer Advances 2018: ASCO’s Annual Report on Progress Against Cancer, which highlights the most impactful cancer research progress and the importance of federally funded research, ASCO recognized a type of adoptive cell immunotherapy—chimeric antigen receptor (CAR) T-cell therapy—as...
Changing Negative Perceptions on the Impact of Clinical Trials in Brazil
CLINICAL TRIALS are an essential research tool to advance medical knowledge and patient care. Traditionally, the majority of pharmaceutical-sponsored clinical trials have been implemented in Western Europe and North America. More recently, however, large pharmaceutical companies have increased...
EXPERT POINT OF VIEW: Zsofia Kinga Stadler, MD
DISCUSSANT ZSOFIA KINGA STADLER, MD, of Memorial Sloan Kettering Cancer Center, found the nivolumab (Opdivo)/ipilimumab (Yervoy) combination results very encouraging but was also impressed with the monotherapy arm. Both approaches are significant advances in treatment, she said. “The treatment of ...
FDA Approves Radiopharmaceutical for Rare Gastrointestinal Cancers
On January 26, 2018, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The drug is indicated for adult patients with somatostatin receptor–positive GEP-NETs. GEP-NETs can be...
Up-to-Date Labels for Older Drugs Essential for Appropriate Use
Oncology drug labels, especially those that have been on the market for more than 15 years, may not always be up-to-date. Critical data about safety, efficacy, or prescribing information may be missing. Modernizing the labeling process can correct inaccurate information, add data for indications ...
Pembrolizumab in MSI-H or dMMR Solid Tumors: ‘First Tissue/Site-Agnostic’ Approval by FDA
On May 23, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors progressing following prior treatment and who have no...
Enasidenib in IDH2-Mutant Relapsed or Refractory Acute Myeloid Leukemia
On August 1, 2017, the IDH2 inhibitor enasidenib (Idhifa) was granted regular approval for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved...
FDA Takes Steps to Improve Transparency in Clinical Trial Information Related to New Drugs
As part of the U.S. Food and Drug Administration’s (FDA) efforts to enhance transparency around its drug-approval decisions, the FDA is exploring new ways to build on its obligation to share information about product approvals, as announced by FDA Commissioner Scott Gottlieb, MD. The FDA is...
Clinical Hold on BPX-501 Trials in the United States Announced
On January 30, Bellicum Pharmaceuticals announced it has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501—an agent being studied to improve outcomes for patients undergoing stem cell transplant who lack a matched donor—have been placed...
Patients With Melanoma Treated With Anti–PD-1 Antibodies Beyond RECIST Progression
A pooled analysis by the U.S. Food and Drug Administration (FDA) has shown a benefit of treatment beyond progression, as defined by RECIST criteria, in many patients receiving anti–programmed cell death protein 1 (PD-1) antibodies for unresectable or metastatic melanoma. The analysis was ...
CAR T-Cell Immunotherapy Named Advance of the Year in ASCO’s Clinical Cancer Advances 2018
A new and unique new way to treat cancer—chimeric antigen receptor (CAR) T-cell therapy—is poised to transform the outlook for children and adults with certain otherwise incurable cancers. ASCO named this type of adoptive-cell immunotherapy the Advance of the Year in its annual...
FDA Approves Lutetium Lu-177 Dotatate for Treatment of Gastroenteropancreatic Neuroendocrine Tumors
On January 26, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radiopharmaceutical has been approved for the treatment of GEP-NETs. Lu-177 dotatate is...
FDA Grants Priority Review for Daratumumab in Front-Line Multiple Myeloma Setting
On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...
Against All Odds
The days leading up to our daughter Emily’s diagnosis of acute lymphoblastic leukemia (ALL) on May 28, 2010, when she was just 5, offered few clues about the terrifying, life-and-death months and years we were about to experience. She was happy and seemingly healthy, literally until the day before...
FDA Approves Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia
ON JANUARY 15, 2018, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly diagnosed low-risk acute promyelocytic leukemia whose disease is characterized by the presence of the...
FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who...
FDA Approves Afatinib for Previously Untreated, Metastatic NSCLC With Other Nonresistant EGFR Mutations
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations ...
Ceritinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer
On May 26, 2017, ceritinib (Zykadia) was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a U.S. Food and Drug Administration–approved test.1,2 In 2014, the drug received ...
ASCO Calls for Streamlining of Adverse Events Reporting for Cancer Clinical Trials
ASCO HAS released recommendations to streamline serious adverse events reporting for cancer clinical trials. The ASCO research statement, published last month in the Journal of Clinical Oncology (JCO), discusses strategies to address the high volume of uninformative adverse events reports submitted ...
Trastuzumab-dkst Approved as Biosimilar to Trastuzumab
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 1, 2017, trastuzumab-dkst (Ogivri) was...
Novel Antibody-Drug Conjugate Active in Refractory Triple-Negative Breast Cancer
In relapsed or refractory triple-negative breast cancer, the antibody-drug conjugate sacituzumab govitecan (IMMU-132) demonstrated significant clinical activity in an open-label study presented at the 2017 San Antonio Breast Cancer Symposium.1 “Metastatic triple-negative breast cancer is an...
Safety Information on Rolapitant Injectable Emulsion
The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing health-care providers about new safety information for rolapitant (Varubi) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and...
FDA Accepts sBLA, Grants Priority Review for Tisagenlecleucel in Adults With DLBCL
Today, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) for tisagenlecleucel (Kymriah) suspension for intravenous infusion (formerly CTL019) for the treatment of adult patients with relapsed or refractory diffuse large...
Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia Approved by the FDA
On January 15, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17)...
FDA Approves Afatinib for Previously Untreated, Metastatic NSCLC With Other Nonresistant EGFR Mutations
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR)...
FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been...
Lenvatinib and Pembrolizumab Combination Receives Breakthrough Therapy Designation for Advanced Renal Cell Carcinoma
On January 9, Eisai and Merck announced that they received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor lenvatinib (Lenvima) in combination with Merck's anti–programmed cell death protein 1...
FDA Approves Denosumab for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for denosumab (Xgeva) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients...
Ribociclib Receives FDA Breakthrough Therapy Designation in Premenopausal Women With Hormone Receptor–Positive, HER2-Negative Breast Cancer
On January 3, ribociclib (Kisqali) received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with...
FDA Accepts sBLA, Grants Priority Review for Brentuximab Vedotin in Advanced Hodgkin Lymphoma
On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also...
FDA Accepts sNDA, Grants Priority Review to Adjuvant Dabrafenib/Trametinib in BRAF V600E/K Mutation–Positive Melanoma
On December 22, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E...
FDA Grants Breakthrough Therapy Designation to Combination of Avelumab and Axitinib in Advanced Renal Cell Carcinoma
On December 21, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to avelumab (Bavencio) in combination with axitinib (Inlyta) for treatment-naive patients with advanced renal cell carcinoma. “A combination approach with an immunotherapy, whose activity may ...
FDA Updates Nilotinib Label With Information on Discontinuing Treatment in Certain Patients With Early-Phase CML After Sustained Response
On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...
FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer
On December 22, the U.S. Food and Drug Administration (FDA) cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With [this] clearance, patients will have access to a treatment option that provides greater accuracy in delivering...
Lower Dose of Cabazitaxel in Prostate Cancer
On September 14, 2017, the microtubule inhibitor cabazitaxel (Jevtana) was approved at the lower dose of 20 mg/m2 every 3 weeks in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.1,2...
Brentuximab Vedotin for Adult Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
On November 9, 2017, brentuximab vedotin (Adcetris) received regular approval for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy.1,2 Supporting Efficacy Data Approval was based on...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). Approval was based on data from an open-label,...
Gemtuzumab Ozogamicin in CD33-Positive Acute Myeloid Leukemia
On September 1, 2017, gemtuzumab ozogamicin (Mylotarg) was approved for treatment for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients aged ≥ 2 years.1,2 It may be used in combination...
Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer
Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...
FDA Helps Streamline Approval Process for Supplemental Drug Indications
As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...
Neratinib Is Approved: Should We Reject It Anyway?
The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Approval was...
Obinutuzumab in Previously Untreated Follicular Lymphoma
On November 16, 2017, obinutuzumab (Gazyva) was granted regular approval in combination with chemotherapy, followed by obinutuzumab monotherapy for patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular...
Broadening the Evidence Base for Older Patients: FDA-ASCO Workshop Explores Emerging Strategies
In the not-so-distant past, clinical trials were considered an option only for the young and fit. Enrolling older people “used to be thought unethical,” said Janet Woodcock, MD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), as she opened...
Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma
On November 16, 2017, sunitinib malate (Sutent) was approved for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.1,2 Supporting Efficacy Data Approval was based on the findings of the double-blind phase III S-TRAC trial in which 615...
Lung Cancer in Never Smokers: A Complex Clinical Phenomenon
Despite advances in prevention, early detection, and treatments, lung cancer remains the leading cause of cancer-related death in the United States. Although cigarette smoking is the main cause of lung cancer, about 10% of these patients are lifelong never smokers for whom the molecular...
FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular -approval to cabozantinib -(Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have...
Checkpoint Inhibition for Patients With Recurrent or Advanced Cervical Cancer: A Promising Strategy, but Which Patients Will Benefit the Most?
For nearly 20 years, chemoradiation using single-agent platinum therapy has been the standard of care for advanced or recurrent cervical cancer.1 More recently, the Gynecologic Oncology Group (GOG) 240 trial tested the addition of bevacizumab (Avastin) to platinum-based chemotherapy, which...
