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Showing 1751 - 1800ASCO 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...
FDA Authorizes First Next-Generation Sequencing–Based Test to Detect Minimal Residual Disease in B-Cell ALL or Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently permitted marketing of the ClonoSEQ assay, a next-generation sequencing–based test for minimal residual disease in patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma. “At the FDA, we’re continuing to...
Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome
On August 8, 2018, the CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody mogamulizumab-kpkc (Poteligeo) was approved for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.1,2 Supporting Efficacy Data The current...
Targeting CCR4 in Cutaneous T-Cell Lymphoma: The MAVORIC Trial
The C-C chemokine receptor 4 (CCR4) is predominantly expressed in type 2 helper T (Th2) cells and regulatory T (Treg) cells.1 Under physiologic conditions and in response to its ligands, CCL17 (TARC) and CCL22 (MDC), CCR4 promotes T-cell migration to the skin.2 Of note, CCR4 is highly expressed in...
Mogamulizumab Improves Progression-Free Survival vs Vorinostat in Cutaneous T-Cell Lymphoma
As reported by Youn H. Kim, MD, of Stanford Cancer Institute, Stanford University School of Medicine, and colleagues in The Lancet Oncology, the phase III MAVORIC trial showed that the anti-C-C chemokine receptor 4 (CCR4) monoclonal antibody mogamulizumab (Poteligeo) significantly improved...
Osimertinib in First-Line Treatment of EGFR-Mutant Metastatic NSCLC
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. In April 2018, osimertinib (Tagrisso) was approved for...
AACR Releases Annual Cancer Progress Report
The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report,1 highlighting how federally funded research discoveries are fueling the development of new and even more effective ways to prevent, detect, diagnose, and treat cancer. Key advances outlined in the...
Neuroendocrine Tumors: New Data, New Options
Because neuroendocrine tumors are not one disease but a continuum of diseases, ranging from well-differentiated tumors to poorly differentiated and small cell tumors, treatment approaches can vary greatly. At the 2018 Debates and Didactics in Hematology and Oncology conference, held on Sea Island,...
FDA Approves Once-Weekly Carfilzomib in Combination With Dexamethasone for Relapsed or Refractory Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) to expand the prescribing information for carfilzomib (Kyprolis) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or...
FDA Approves Cemiplimab-rwlc for Metastatic Cutaneous Squamous Cell Carcinoma
On September 28, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (SCC) or locally advanced cutaneous SCC who are not candidates for curative surgery or...
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 CLL, SLL, and Follicular Lymphoma
On September 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib (Copiktra) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib...
FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia
ON SEPTEMBER 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies,...
Pertuzumab in Adjuvant Treatment of HER2-Positive Breast Cancer
AT THE END OF 2017, pertuzumab (Perjeta) was granted regular approval 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.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
Abiraterone Acetate Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
IN EARLY 2018, abiraterone acetate tablets (Yonsa, Zytiga) in combination with prednisone was approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS BASED on findings from the phase III LATITUDE trial, in which 1,199...
FDA Grants Rare Pediatric Disease Designation to CLR 131 in Treatment of Osteosarcoma
The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to CLR 131 for the treatment of osteosarcoma. CLR 131 has received Rare Pediatric Disease designation in four pediatric cancers: neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, and now...
FDA Accepts sBLA for Pembrolizumab Monotherapy in First-Line Treatment of Locally Advanced or Metastatic PD-L1–Expressing NSCLC
The U.S. Food and Drug Administration (FDA) granted Priority Review to a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non–small cell lung...
ASCO and Friends of Cancer Research Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation
On August 8, ASCO and Friends of Cancer Research (Friends) submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration...
Are E-Cigarettes a Dangerous Alternative to Traditional Cigarettes?
Several studies published earlier this year present preliminary but compelling evidence that electronic cigarettes, also known as e-cigarettes, which deliver nicotine through aerosols without burning tobacco, may pose serious health consequences to users, including cardiovascular disease and...
CAR T-Cell Therapy for CLL
A pair of new studies from researchers at the Abramson Cancer Center of the University of Pennsylvania are shedding light on why patients with advanced chronic lymphocytic leukemia (CLL) respond or do not respond to chimeric antigen receptor (CAR) T-cell therapy. Although CAR T-cell therapy is...
Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy
In June 2018, pembrolizumab (Keytruda) was approved for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1; combined positive score [CPS] ≥ 1), as determined by a U.S....
Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma
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 June 13, 2018, pembrolizumab (Keytruda) was granted...
Update on Clinical Trials of Novel Therapies
Long-term follow-up data on axicabtagene ciloleucel (Yescarta) in lymphoma, potential partners for nivolumab (Opdivo) in solid tumors, and a targeted agent for RET-altered cancers were featured during the developmental therapeutics program at the 2018 ASCO Annual Meeting. At the Best of ASCO...
FDA Takes New Steps to Address Youth E-Cigarette Use
The U.S. Food and Drug Administration (FDA) has announced a series of critical and historic enforcement actions related to the sale and marketing of e-cigarettes to children. In the largest coordinated enforcement effort in the its history, the agency issued more than 1,300 warning...
New Recommendations for Cabozantinib Tablets in Updated NCCN Clinical Practice Guidelines
Recently, the National Comprehensive Cancer Network® (NCCN®) updated its Clinical Practice Guidelines to include new recommendations for cabozantinib (Cabometyx) tablets. With the updates, cabozantinib is recommended by the NCCN for the treatment of advanced renal cell carcinoma regardless...
FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia
The U.S. Food and Drug Administration (FDA) today approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with...
