Search Results
Your search for ,Fda matches 3753 pages
Showing 1751 - 1800First Rituximab Biosimilar for Non-Hodgkin Lymphoma Approved by FDA
Today, the U.S. Food and Drug Administration (FDA) approved rituximab-abbs (Truxima) as the first biosimilar to rituximab (Rituxan) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma to be used as a single agent or in combination with chemotherapy. Rituximab-abbs is ...
FDA Approves Venetoclax Combination for Adults With AML
On November 21, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to venetoclax (Venclexta) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or...
FDA Approves Larotrectinib for Solid Tumors With NTRK Gene Fusions
On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib (Vitrakvi) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, whose...
FDA Approves Pembrolizumab for Hepatocellular Carcinoma Previously Treated With a Kinase Inhibitor
ON NOVEMBER 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib (Nexavar). KEYNOTE-224 APPROVAL WAS based on KEYNOTE-224, a...
Nivolumab for Third-Line Treatment of Metastatic Small Cell Lung Cancer
ON AUGUST 16, 2018, nivolumab (Opdivo) was granted accelerated approval for treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression after platinum-based chemotherapy and at least one other line of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
ON NOVEMBER 16, 2018, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic...
Iobenguane I-131 for Advanced Pheochromocytoma or Paraganglioma
ON JULY 30, 2018, the radiotherapeutic agent iobenguane I-131 (Azedra) was approved for the treatment of adult and pediatric patients (aged ≥ 12 years) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
ON NOVEMBER 6, 2018, following Priority Review, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at...
FDA Approves Glasdegib for Patients With Newly Diagnosed AML Who Cannot Undergo Intensive Chemotherapy
Today, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo) tablets to be used in combination with low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or with comorbidities that may preclude the use of ...
Cemiplimab-rwlc for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
On September 28, 2018, cemiplimab-rwlc (Libtayo) was approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.1 Supporting Efficacy Data Approval...
Duvelisib in Resistant Chronic Lymphocytic Leukemia: Expanding the Treatment Armamentarium
The phase III DUO trial, reported by Flinn et al and reviewed in this issue of The ASCO Post, has led to the U.S. Food and Drug Administration (FDA) approval of a novel B-cell receptor (BCR) kinase inhibitor, duvelisib (Copiktra), which targets phosphoinositide 3-kinase (PI3K)-δ/γ in patients...
Dacomitinib for Metastatic EGFR-Mutant NSCLC
On September 27, 2018, dacomitinib (Vizimpro) received approval for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by a test approved by the...
FDA Approves Lorlatinib for Second- or Third-Line Treatment of ALK-Positive Metastatic NSCLC
On November 2, 2018, the U.S. Food and Drug Administration granted accelerated approval to lorlatinib (Lorbrena) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK ...
Steven A. Rosenberg, MD, PhD, Works to Unmask Cancer’s Achilles Heel
Steven A. Rosenberg, MD, PhD, knew from the start of his medical career that if treatments for cancer were to become curative, research in new therapies would have to move away from the mainstay one-size-fits-all approach of systemic chemotherapy to an innovative, personalized strategy that...
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
Today, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic large cell...
FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...
FDA Approves Pembrolizumab for Hepatocellular Carcinoma Previously Treated With a Kinase Inhibitor
On November 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib. KEYNOTE-224 Approval was based on KEYNOTE-224, a single-arm,...
Venetoclax for CLL or SLL With or Without 17p Deletion After Prior Therapy
On June 8, 2018, venetoclax (Venclexta) was granted regular approval for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on ...
Progression-Free Survival and Health-Related Quality of Life in Randomized Clinical Trials
A review and analysis of randomized clinical trials published by Kovic et al in JAMA Internal Medicine questioned whether interventions that prolong progression-free survival (PFS) in patients with cancer improve their health-related quality of life (HRQoL). The systematic review and quantitative...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies,...
Thomas J. Dougherty, PhD, Father of Photodynamic Therapy, Dies at Age 85
Thomas J. Dougherty, PhD, the developer of modern photodynamic therapy and Chief Emeritus of Roswell Park’s Photodynamic Therapy Center, died October 2, 2018, in Buffalo, New York. “He was undoubtedly the major influence in bringing [photodynamic therapy] into the realm of cancer therapy,” said...
Without Genomic Sequencing, I Would Not Be Alive Today
The extreme fatigue I experienced during the winter of my fourth year in medical school, in 2003, was easily attributable to the rigors of my medical training and the lack of sleep that comes from trying to keep up with an intensely busy schedule. I was looking forward to resting and recuperating...
FDA Releases Draft Guidance for Clinical Trial Design
The U.S. Food and Drug Administration (FDA) announced the availability of the Draft Guidance Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics. Master protocol trial designs are complex due to the concurrent evaluation of multiple...
Nilotinib for Pediatric Patients With Philadelphia Chromosome–Positive CML in Chronic Phase
Earlier in 2018, nilotinib (Tasigna) was approved for the treatment of pediatric patients aged ≥ 1 year with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (CML-CP) or Philadelphia chromosome–positive CML-CP resistant or intolerant to prior tyrosine...
FDA Approves Levoleucovorin for Treatment in Osteosarcoma, Colorectal Cancer
The U.S. Food and Drug Administration (FDA) recently approved levoleucovorin (Khapzory) injection, a folate analog, for three indications: rescue after high-dose methotrexate therapy in patients with osteosarcoma; diminishing the toxicity associated with overdosing on folic acid antagonists or...
ASCO Submits Comment Letters to the FDA on Modernizing Clinical Trials
ASCO recently submitted two comment letters from ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, to the U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, related to the modernization of clinical trials. The first letter provided the FDA with comments on...
Health-Policy Forum Focuses on New Care-Delivery Paradigms
What was an MBA doing at the podium of a clinical oncology meeting? Ten years ago or so, that might have been surprising. But in an era of rapid change—in therapies, costs, payment models, and practice—it only makes sense. Amy Porter-Tacoronte, MBA, Health System Chief Administrative Officer at the ...
FDA Approves Lorlatinib for Second- or Third-Line Treatment of ALK-Positive Metastatic NSCLC
On November 2, 2018, the U.S. Food and Drug Administration granted accelerated approval to lorlatinib (Lorbrena) for patients with anaplastic lymphoma kinase (ALK)–positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least...
FDA Grants Breakthrough Therapy Designation to LOXO-292 for RET Fusion–Positive Thyroid Cancer
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion–positive thyroid cancer who require systemic therapy, have had disease progression following...
ESMO 2018: CheckMate-142 Reports New Data on First-Line Nivolumab Plus Low-Dose Ipilimumab in MSI-H/dMMR Metastatic Colorectal Cancer
The combination of nivolumab (Opdivo) and low-dose ipilimumab (Yervoy) could become a new first-line treatment in patients with microsatellite instability–high (MSI-H), mismatch repair–deficient (dMMR) metastatic colorectal cancer, following results from the CheckMate-142 trial reported ...
FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC
On October 30, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with carboplatin and either paclitaxel or nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) as first-line treatment of metastatic squamous non–small cell lung...
FDA Approves Levoleucovorin for Treatment in Osteosarcoma, Colorectal Cancer
The U.S. Food and Drug Administration (FDA) recently approved levoleucovorin (Khapzory) injection, a folate analog, for three indications: rescue after high-dose methotrexate therapy in patients with osteosarcoma; diminishing the toxicity associated with overdosage of folic acid...
Has the Promise of Precision Medicine Been Oversold?
Recently, the term “personalized medicine” in oncology care has been overtaken by the more contemporary concept of “precision medicine.” According to the National Research Council of the National Academies of Science, Engineering, and Medicine, the newer terminology shifts the focus to improving...
Everolimus Tablets for Oral Suspension for Tuberous Sclerosis Complex–Associated Partial-Onset Seizures
On April 10, 2018, the U.S. Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz) for the adjunctive treatment of adult and pediatric patients aged ≥ 2 years with tuberous sclerosis complex–associated partial-onset seizures.1,2 Tuberous sclerosis complex is ...
On the Frontier of Breast Cancer Research With Joyce A. O’Shaughnessy, MD
Nationally regarded breast cancer researcher and clinician Joyce A. O’Shaughnessy, MD, was born in upstate New York, just outside of Albany, where she attended grade school before her family moved to Beverly, Massachusetts, a suburban town 26 miles from Boston, where her family’s roots were....
Talazoparib Approved for BRCA-Mutated, HER2-Negative Breast Cancer
On October 16, 2018, the U.S. Food and Drug Administration approved talazoparib (Talzenna), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Patients must be...
Labeling Act to Keep Drug Label Information Up-to-Date Introduced to Senate
Friends of Cancer Research (Friends) recognized Senators Orrin Hatch (R–UT) and Michael Bennet (D–CO) for responding to a recently identified public health issue and proposing a solution to an issue impacting patients and their physicians. Senators Hatch and Bennet jointly introduced the Making...
FDA Awards Research Grants in Development of Treatments of Rare Diseases, Cancers
The U.S. Food and Drug Administration (FDA) has announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next 4 years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal...
Cabozantinib in Advanced Hepatocellular Cancer: Call for Revision of Practice Standards
As reported in The New England Journal of Medicine by Ghassan K. Abou-Alfa, MD, and colleagues, and reviewed in this issue of The ASCO Post, the phase III CELESTIAL trial has demonstrated that cabozantinib (Cabometyx) improved the median overall survival to 10.2 months in comparison to 8 months...
Nivolumab Plus Ipilimumab in Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma
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 April 16, 2018, nivolumab (Opdivo) and ipilimumab...
Next-Generation Sequencing: New Technology That Requires Further Thought
Next-generation sequencing is used with increasing frequency to provide essential information about a patient’s diagnosis and treatment. In recent months, the U.S. Food and Drug Administration (FDA) has approved several new next-generation sequencing diagnostic tools, and the Centers for Medicare...
Current Treatment Landscape of Relapsed or Refractory Chronic Lymphocytic Leukemia
Novel agents such as ibrutinib (Imbruvica), idelalisib (Zydelig), and venetoclax (Venclexta) have transformed the treatment of chronic lymphocytic leukemia (CLL) and are increasingly used to treat the disease. The optimal sequencing of these agents is not clear in relapsed or refractory disease,...
How the Nobel Prize Could Spur More Cancer Advances
Even before James P. Allison, PhD, made an appearance at the Fourth International Cancer Immunotherapy Conference: Translating Science Into Survival in New York City, the excitement among attendees was palpable. Earlier that day, October 1, 2018, Dr. Allison and Tasuku Honjo, MD, PhD, of Kyoto...
FDA Approves Talazoparib for Deleterious Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the U.S. Food and Drug Administration (FDA) approved talazoparib (Talzenna), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer....
FDA Accepts New Drug Application, Grants Priority Review to Selinexor for Pentarefractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted a new drug application seeking accelerated approval for selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with pentarefractory multiple myeloma. The FDA...
Rucaparib for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
IN APRIL 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib (Rubraca) was granted approval for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2...
FDA Approves Dacomitinib for Metastatic Non–Small Cell Lung Cancer
ON SEPTEMBER 27, 2018, the U.S. Food and Drug Administration (FDA) approved dacomitinib tablets (Vizimpro) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution...
FDA Approves Duvelisib for Adult Patients With Relapsed or Refractory Hematologic Malignancies
ON SEPTEMBER 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib (Copiktra) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Duvelisib also received accelerated...
FDA Approves Expanded Use of Gardasil 9 to Include Individuals Aged 27 to 45
The U.S. Food and Drug Administration (FDA) has approved a supplemental application for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and...
FDA Grants Breakthrough Therapy Designation to Rucaparib in BRCA1/2-Mutated Metastatic Castration-Resistant Prostate Cancer
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to rucaparib (Rubraca) monotherapy for the treatment of adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer who have received at least one prior androgen...
