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PD-L1–Positive Non–Small Cell Lung Cancer
In this video, Drs. Justin F. Gainor, Ibiayi Dagogo-Jack, and Jyoti D. Patel discuss current therapy options for PD-L1–positive non–small cell lung cancer (NSCLC). Dr. Gainor presents the case of a 65-year-old man with 55-year smoking history who was diagnosed with stage II NSCLC. The faculty...
NTRK Fusion–Positive Non–Small Cell Lung Cancer
In this video, Drs. Justin F. Gainor, Ibiayi Dagogo-Jack, and Jyoti D. Patel discuss the management of NTRK fusion–positive non–small cell lung cancer (NSCLC). Dr. Gainor presents the case of a 44-year-old man with a 5 pack-year history of tobacco exposure who was diagnosed with metastatic NSCLC;...
FDA Grants Approval to the Pfizer-BioNTech COVID-19 Vaccine
On August 23, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals aged 16 years and older. The vaccine also...
Caution With Robotically Assisted Surgical Devices for Mastectomy: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is reminding patients and health-care providers that the safety and effectiveness of robotically assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA...
FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma
On August 19, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant...
FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors
On August 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli), an anti–PD-1 antibody, for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, who have had disease...
FDA Approves Belzutifan for Cancers Associated With von Hippel-Lindau Disease
On August 13, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg), a hypoxia-inducible factor inhibitor, for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or...
FDA Pipeline: Reviews for Agents in Lung Cancer, Thyroid Cancer, Kidney Cancer, and More
Recently, the U.S. Food and Drug Administration (FDA) accepted applications for agents aiming to treat non–small cell lung cancer (NSCLC), differentiated thyroid cancer, renal cell carcinoma (RCC), hypersensitive acute lymphoblastic leukemia (ALL), mucosal melanoma, and endometrial carcinoma....
FDA Approves Lenvatinib/Pembrolizumab for Advanced Renal Cell Carcinoma
On August 10, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). CLEAR Trial The efficacy of this combination was investigated in CLEAR...
Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
On June 30, 2021, asparaginase erwinia chrysanthemi (recombinant)-rywn was approved as a component of a multiagent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed...
CAR T-Cell Gene Therapy in Non-Hodgkin Lymphomas
To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel gene therapies for resistant non-Hodgkin lymphomas (NHL), including...
A New Era of Hope for Patients With Triple-Negative Breast Cancer
Triple-negative breast cancer is a particularly devastating subtype of breast cancer, as it is often diagnosed in young women and is associated with an exceptionally poor prognosis. The “triple-negative” designation indicates that the three key features driving most breast cancers (estrogen...
KEYNOTE-522: Neoadjuvant Pembrolizumab Improves Event-Free Survival in Triple-Negative Breast Cancer
The latest analysis of the pivotal phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III...
FDA Alert: Clinical Trial Results Show an Increased Risk of Death Associated With Melphalan Flufenamide
The U.S. Food and Drug Administration (FDA) is alerting patients and health-care professionals that a clinical trial (OCEAN, Study OP-103; ClinicalTrials.gov identifier: NCT03151811) evaluating melphalan flufenamide with dexamethasone to treat patients with multiple myeloma showed an increased risk ...
FDA Approves Pembrolizumab in Combination for High-Risk, Early-Stage Triple-Negative Breast Cancer
On July 26, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. The FDA also...
Lorlatinib for Metastatic ALK-Positive NSCLC
On March 3, 2021, lorlatinib was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) with ALK-positive tumors as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA simultaneously approved the Ventana ALK (D5F3) CDx Assay ...
Pembrolizumab Combined With Chemotherapy for Advanced Esophageal or Gastroesophageal Junction Carcinoma
On March 22, 2021, pembrolizumab was approved for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1 to 5 cm above the gastroesophageal junction) carcinoma who...
Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma
On March 10, 2021, the VEGF tyrosine kinase inhibitor tivozanib was approved for treatment of adults with relapsed or refractory advanced renal cell carcinoma following at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on findings in the open-label, phase III...
Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Endometrial Cancer
On April 22, 2021, the PD-1 inhibitor dostarlimab-gxly was granted accelerated approval for treatment of adults with mismatch repair–deficient recurrent or advanced endometrial cancer, as determined by a U.S. Food and Drug Administration (FDA)-approved test, that has progressed on or following a...
Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma
On March 5, 2021, the CD19-directed genetically modified autologous T-cell immunotherapy axicabtagene ciloleucel was granted accelerated approval for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1,2 Axicabtagene ciloleucel is...
Avapritinib for Advanced Systemic Mastocytosis
On June 16, 2021, avapritinib was approved for the treatment of adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.1,2 Avapritinib is not recommended...
Role of PI3K Inhibition in Indolent Lymphomas
As reported by Fowler et al in the Journal of Clinical Oncology1—and summarized in this issue of The ASCO Post—the international phase IIb UNITY-NHL trial of 208 patients with marginal zone lymphoma (MZL; n = 69), follicular lymphoma (FL; n = 117), and small lymphocytic lymphoma (SLL; n = 22)...
Expert Point of View: Clifford Goodman, PhD
Moderator of the session at the National Comprehensive Cancer Network Virtual Oncology Policy Summit, Clifford Goodman, PhD, Senior Vice President at The Lewin Group, said he was struck by the diverse impacts that the COVID-19 pandemic had on cancer care. One area that remained relatively...
FDA Pipeline: Designations for Therapies in Myelodysplastic Syndromes and Triple-Negative Breast Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted special designation status to treatments for myelodysplastic syndromes and advanced triple-negative breast cancer. Breakthrough Therapy Designation for Venetoclax in Combination With Azacitidine for Myelodysplastic Syndromes Venetoclax...
Pembrolizumab/Lenvatinib Granted Regular Approval for Advanced Endometrial Carcinoma
On July 21, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR). These patients must have ...
Study Identifies MET Amplification as a Driver for Some Non–Small Cell Lung Cancers
A study published by D. Ross Camidge, MD, PhD, and colleagues in the Journal of Thoracic Oncology has helped to define MET amplification as a rare but potentially actionable driver for non–small cell lung cancer (NSCLC). Dr. Camidge said many of the major developments in the treatment of NSCLC have ...
FDA Approves Belumosudil for Chronic Graft-vs-Host Disease
On July 16, the U.S. Food and Drug Administration (FDA) approved belumosudil (Rezurock), a kinase inhibitor, for adult and pediatric patients aged 12 years and older with chronic graft-vs-host disease after failure of at least two prior lines of systemic therapy. KD025-213 Efficacy was evaluated in ...
FDA Approval in Urothelial Cancer, Plus Mechanisms of Acquired Resistance in KRAS G12C–Mutant Cancers
On this episode, we're reviewing the FDA full approval of a therapy for previously treated patients with advanced urothelial cancer. Then, we'll hear about a trial that investigated potential mechanisms of acquired resistance to KRAS G12C inhibitors in patients with KRAS G12C–mutant cancers.
VISION Trial: Novel PSMA-Targeted Radiotherapy Improves Outcomes in Metastatic Prostate Cancer
Lutetium-177–PSMA-617 (LuPSMA)—an investigational radiolabeled small molecule—significantly improved radiographic progression-free survival and overall survival when added to the standard of care compared with the standard of care alone for men with metastatic castration-resistant prostate cancer...
FDA Approves Daratumumab and Hyaluronidase-fihj With Pomalidomide and Dexamethasone for Pretreated Patients With Multiple Myeloma
On July 9, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a...
ASCO Releases New Recommendations on Systemic Therapy Dosing for Adults With Obesity and Cancer
ASCO has approved new recommendations for the appropriate dosing of systemic anticancer agents in adults with obesity and cancer.1 The guideline update was based on evidence collected from a systematic review of the literature published between November 1, 2010, and March 27, 2020, regarding dosing ...
Predicting Global Cancer Trends in 2021
Although we are just halfway through 2021, the outlook for improvements in global cancer trends looks grim. According to new estimates by the International Agency for Research on Cancer’s Global Cancer Observatory, the global cancer burden rose to 19.3 million cases and 10 million deaths in 2020...
Sacituzumab Govitecan-hziy: Welcome Addition to Advanced Urothelial Cancer Treatments, but Time to Figure Out Sequencing and Combinations
The results of Cohort 1 of the phase II trial TROPHY-U-01 (IMMU-132-06; ClinicalTrials.gov identifier NCT03547973), published in the Journal of Clinical Oncology by Tagawa et al and reviewed in this issue of The ASCO Post, led to the recent accelerated U.S. Food and Drug Administration (FDA)...
Enfortumab Vedotin Represents a Community of Work in Antibody-Drug Conjugates Targeting Cancer
The first known clinical trial report of an antibody-drug conjugate was a phase 0/I pharmacodynamic and safety study of a conjugate that targeted carcinoembryonic antigen and delivered a payload of vinca alkaloid in eight patients with ovarian or colorectal cancer.1 This work built on the work of...
Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer
On May 20, 2021, nivolumab was approved for adjuvant treatment of patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease after neoadjuvant chemoradiotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the...
5- vs 2-Year Course of Zoledronate for Patients With Early Breast Cancer
On this week's episode, we’re discussing the effect of a 5- vs 2-year course of zoledronate for patients with early breast cancer; a recent FDA approval in locally advanced cutaneous squamous cell carcinoma; and a study that examined how reduced time to completion of treatment in patients with...
Enfortumab Vedotin-ejfv Granted Regular Approval in Treatment of Locally Advanced or Metastatic Urothelial Cancer
On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and...
FDA Approves Expanded Indication for Pembrolizumab in Locally Advanced Cutaneous Squamous Cell Carcinoma
On July 6, the U.S. Food and Drug Administration (FDA) approved an expanded label for pembrolizumab, an anti–PD-1 agent, as monotherapy for patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation. This approval is based on data from the second...
FDA Pipeline: Recent Designations in NSCLC, Leukemia, and Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for non–small cell lung cancer (NSCLC), acute leukemia, and mantle cell lymphoma. Breakthrough Therapy Designation for Adagrasib in Advanced NSCLC With KRAS G12C Mutation On June 24, 2021, the...
FDA Approves Alternative to E coli–Derived Asparaginase for Leukemia and Lymphoma
On June 30, 2021, the U.S. Food and Drug Administration (FDA) approved asparaginase Erwinia chrysanthemi (recombinant)-rywn (Rylaze) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma in adult and pediatric...
Use of Germline Mutation Profiling in Patients With Advanced Cancers
In a study reported in the Journal of Clinical Oncology, Zsofia K. Stadler, MD, and colleagues found that germline mutation testing revealed therapeutically actionable variants in 8% of patients with recurrent or metastatic cancers, with 40% of them receiving directed treatment. As stated by the...
FDA Encourages Inclusion of Patients With Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies
On June 24, 2021, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, made the following statement: “Today, the FDA issued a draft...
Loncastuximab Tesirine-lpyl for Relapsed or Refractory Large B-Cell Lymphoma
On April 23, 2021, loncastuximab tesirine-lpyl, a CD19-directed antibody and alkylating agent conjugate, was granted accelerated approval for 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...
Innovator in Treatment of Infectious Diseases, Francisco Marty, MD, Dies at 53
The Brigham and Women’s hospital community mourns the loss of Francisco Marty, MD, of the Division of Infectious Diseases, who died April 8, 2021, after a tragic accident while hiking in the Dominican Republic. He was 53. A member of the Brigham community for more than 20 years, Dr. Marty is...
Sotorasib: Subgroup Analysis of Phase II Trial Shows Activity With Breakthrough KRAS Inhibitor in Lung Cancer
The breakthrough KRAS-specific inhibitor sotorasib achieved responses in patients with KRAS G12C–mutated non–small lung cancer (NSCLC) who had experienced disease progression on platinum-based chemotherapy, immunotherapy, or both treatments. The objective response rate was 37.1%, and responses...
OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
FDA Pipeline: Priority Reviews in Multiple Myeloma, Cervical Cancer, Neutropenia, and Myelofibrosis
Over the past month, the U.S. Food and Drug Administration (FDA) has granted Priority Review to therapies for multiple myeloma, cervical cancer, chemotherapy-induced neutropenia, and myelofibrosis. The FDA also granted a number of Breakthrough Therapy designations, including those for treatments in ...
FDA Oncology Center of Excellence Launches National Black Family Cancer Awareness Week
The U.S. Food and Drug Administration (FDA)'s Oncology Center of Excellence (OCE) has announced its inaugural National Black Family Cancer Awareness Week, which is taking place from June 17 through June 23, 2021. Throughout the week, the agency’s social media platforms will serve as the hub for...
Novel Monoclonal Antibody Emerges as Potential First-Line Standard in Nasopharyngeal Cancer
A new first-line standard of care may be emerging for recurrent or metastatic nasopharyngeal carcinoma, based on the findings of the global phase III JUPITER-02 trial presented at the 2021 ASCO Annual Meeting by investigators from China.1 In the study, toripalimab, an anti–PD-1 monoclonal antibody, ...
FDA Approves Avapritinib for Advanced Systemic Mastocytosis
On June 16, the U.S. Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor avapritinib (Ayvakit) for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and...
