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Showing 2001 - 2050Selected Abstracts From the San Antonio Breast Cancer Symposium
EACH YEAR, The ASCO Post asks Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, to give his picks for the most important research presented at the San Antonio Breast Cancer...
Lutetium Lu-177 Dotatate in Gastroenteropancreatic Neuroendocrine Tumors
On January 26, 2018, the radiolabeled somatostatin analog lutetium Lu-177 dotatate (Lutathera) was approved for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.1,2 Supporting...
Apalutamide, Enzalutamide Improve Metastasis-Free Survival in Nonmetastatic Castrate-Resistant Prostate Cancer
IN TWO SEPARATE TRIALS presented at the 2018 Genitourinary Cancers Symposium, apalutamide and enzalutamide (Xtandi), respectively, reduced the risk of metastasis and prolonged metastasis-free survival in men with high-risk nonmetastatic castrate-resistant prostate cancer. In the SPARTAN trial,1,2...
FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications
On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will ...
FDA Authorizes Direct-to-Consumer Test That Reports Three Mutations in the BRCA1/BRCA2 Breast Cancer Genes
Today, the U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in...
Multitargeted Tyrosine Kinase Inhibitor Shows Activity in Small Cell Carcinoma of the Ovary
An multitargeted tyrosine kinase inhibitor used to treat leukemia has shown promise against a rare and aggressive type of ovarian cancer—small cell carcinoma of the ovary hypercalcemic type (SCCOHT)—that strikes young women and girls, according to a study led by the Translational...
ASCO, NCCN Provide Guidance on Understanding and Managing Immunotherapy Side Effects
Immunotherapy with immune checkpoint inhibitors is the first of a new generation of immunotherapy treatments, revolutionizing treatment for many different types of cancer. By unleashing the body’s immune system to attack cancer, these treatments can send even the most hard-to-treat cancers into...
Alex Huang, MD, PhD, Receives $450,000 From Pediatric Cancer Research Foundation
Cancer researcher Alex Huang MD, PhD, has received a $450,000 Basic Science grant from the Pediatric Cancer Research Foundation to study targeted approaches for effectively eliminating metastatic osteosarcoma. Dr. Huang is Professor of Pediatrics at Case Western Reserve University School of...
Why Right-to-Try Laws Are Dangerous
Why wouldn’t you support a patient with a terminal illness the “right to try” any therapy that may save his or her life? The answer to this question—one engulfed in a political debate in Congress—seems simple. It is not. [Editor’s Note: On May 30, 2018, the President signed into law the Trickett...
FDA Grants Fast Track Designation to Pamrevlumab in Locally Advanced Unresectable Pancreatic Cancer
On March 1, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the anti–connective tissue growth factor (CTGF) antibody pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the phase II clinical...
GC4419 Receives FDA Breakthrough Therapy Designation for the Reduction of Severe Oral Mucositis
On February 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419, a highly selective and potent small molecule dismutase mimetic, for the reduction of the duration, incidence, and severity of severe oral mucositis induced by radiation therapy with...
FDA Accepts BLA for Calaspargase Pegol in Acute Lymphoblastic Leukemia
On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent chemotherapeutic regimen...
FDA Approves Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
On February 26, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced...
FDA Grants Orphan Drug Designation to YS-ON-001 for the Treatment of Pancreatic Cancer
On February 26, Yisheng Biopharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its lead immuno-oncology candidate, YS-ON-001, for the treatment of pancreatic cancer. YS-ON-001 is a clinical-stage immuno-oncology biologic product...
FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
FDA Approves Abiraterone Acetate Plus 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...
Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients With Advanced NSCLC
On February 15, updated results were made available from the phase III JAVELIN Lung 200 trial comparing avelumab (Bavencio) to docetaxel in patients with unresectable, recurrent, or metastatic non–small cell lung cancer (NSCLC) whose disease progressed after treatment with a...
FDA’s Oncologic Drugs Advisory Committee to Review Potential New Use of Blinatumomab
On February 14, Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the supplemental biologics license application (sBLA) for blinatumomab (Blincyto) for the treatment of patients with minimal residual disease...
FDA Expands Approval of Durvalumab to Reduce the Risk of NSCLC Progression
On February 16, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for the treatment of patients with stage III unresectable non–small cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. “This is the first treatment...
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 on a clinical hold ...
ASCO and NCCN Provide Guidelines for Managing Immunotherapy Side Effects
Immunotherapy with immune checkpoint inhibitors is the first of a new generation of immunotherapy treatments, revolutionizing treatment for many different types of cancer. By unleashing the body's immune system to attack cancer, these treatments can send even the most hard-to-treat cancers into...
FDA Approves Apalutamide for Nonmetastatic, Castration-Resistant Prostate Cancer
The U.S. Food and Drug Administration (FDA) today approved apalutamide (Erleada) for the treatment of patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy. This is the first FDA-approved treatment for nonmetastatic,...
FDA Grants Priority Review to Lorlatinib in ALK-Positive NSCLC
On February 12, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to Pfizer’s new drug application for lorlatinib. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2018. Lorlatinib is an investigational, anaplastic lymphoma...
FDA Grants Premarket Approval to New HPV Assay
On February 14, Becton, Dickinson and Company (BD) announced it had received premarket approval from the U.S. Food and Drug Administration (FDA) for the BD Onclarity human papillomavirus (HPV) assay. The test detects 14 types of high-risk HPV from specimens collected for cervical cancer screening...
2018 GU CANCERS SYMPOSIUM: Combination Therapy Shows Antitumor Activity in Advanced Renal Cell Carcinoma
Combining the antiangiogenic agent axitinib (Inlyta) with the immunotherapy pembrolizumab (Keytruda) was found to have promising antitumor activity and no unexpected side effects in an early-phase clinical trial in patients with advanced kidney cancer who had not been previously treated. The full...
FDA 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...
