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Showing 851 - 900Study 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...
Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression in Extensive-Stage Small Cell Lung Cancer
On February 12, 2021, the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor trilaciclib was approved for use to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide–containing regimen or topotecan-containing regimen for...
Pralsetinib in Advanced RET Fusion–Positive NSCLC: ARROW Trial
As reported in The Lancet Oncology by Justin F. Gainor, MD, and colleagues, an interim analysis of the phase I/II ARROW trial has shown that the oral RET inhibitor pralsetinib produced high response rates in previously treated and treatment-naive patients with advanced RET fusion–positive non–small ...
Expert Point of View: Mansoor Raza Mirza, MD
The invited discussant of EMPOWER-Cervical 1 was Mansoor Raza Mirza, MD, Chief Oncologist at Copenhagen University Hospital and Chairman of the European Network of Gynaecological Oncology Trials group (ENGOT). Dr. Mirza called the findings “amazing” and predicted they will “usher in a new era” in...
Immunotherapy With Cemiplimab-rwlc Yields Survival Benefit in Advanced Cervical Cancer
The PD-L1 inhibitor cemiplimab-rwlc has become the first immunotherapy to yield a statistically significant and clinically meaningful survival benefit in recurrent or metastatic cervical cancer progressing after first-line platinum-containing chemotherapy. Patients were enrolled irrespective of...
FDA Approves New Pediatric Indication for Technetium Tc 99m Tilmanocept Injection
The Lymphoseek (technetium Tc 99m tilmanocept) injection—a radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies—has been approved for pediatric use by the U.S. Food and Drug Administration (FDA). "This new indication opens the door...
Dual Immune Checkpoint Blockade With Nivolumab and Ipilimumab for Treatment of Malignant Pleural Mesothelioma
In recent years, immune checkpoint inhibitors in the treatment of mesothelioma have been a keen area of investigation for this immunogenic solid tumor. With recent publications, principally findings from CheckMate 743 by Baas et al1 (reviewed in this issue of The ASCO Post), combination immune...
Is High Tumor Mutational Burden Predictive of Immune Checkpoint Blockade Efficacy Across All Cancer Types?
In a letter recently published in The New England Journal of Medicine and reviewed in this issue of The ASCO Post, Rousseau and colleagues reported data on the spectrum of benefit from immune checkpoint blockade in hypermutated tumors.1 Indeed, the U.S. Food and Drug Administration (FDA) recently...
Is Tumor Mutational Burden Predictive of Survival Outcomes in Solid Tumors Treated With Immune Checkpoint Inhibitors?
In a letter to the editor in The New England Journal of Medicine, Benoit Rousseau, MD, PhD, and Michael B. Foote, MD, of Memorial Sloan Kettering Cancer Center (MSK), and colleagues presented evidence that a high tumor mutational burden (TMB) threshold of 10 alone may not be sufficient to predict...
Atezolizumab Reduces Risk of Disease Progression in Patients With PD-L1–Expressing Early-Stage NSCLC
Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...
100th Episode: Reports From the 2021 ASCO Annual Meeting in Breast, Prostate, and Lung Cancers
This week marks our 100th episode of the podcast! We launched at the start of the 2019 ASCO Annual Meeting, and this week, we’re reporting major findings from the 2021 Annual Meeting, including adjuvant therapy for patients with BRCA-mutated breast cancer, LuPSMA for metastatic prostate cancer, and ...
Toripalimab Plus Gemcitabine/Cisplatin Extends Progression-Free Survival in Recurrent or Metastatic Nasopharyngeal Carcinoma: JUPITER-02
According to the results from the phase III JUPITER-02 study, the addition of toripalimab, a humanized IgG4K anti–PD-1 monoclonal antibody, to standard gemcitabine/cisplatin chemotherapy as first-line treatment for patients with advanced nasopharyngeal carcinoma provided superior progression-free...
Community-Based Engagement Initiative Improves Accrual of Black Participants in Clinical Trials
A 5-year community outreach and engagement effort by the Abramson Cancer Center at the University of Pennsylvania to increase enrollment of Black patients into cancer clinical trials more than doubled the percentage of participants, improving access and treatment for a group of patients with...
A Junior High School Teacher Sparks a Love for Science
Peter Marks, MD, PhD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER), was born in Brooklyn, New York, near Sheepshead Bay—an area named for the Sheepshead, a fish that can no longer be found in the waters that frame the neighborhood....
A Junior High School Teacher Sparks a Love for Science
Peter Marks, MD, PhD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER), was born in Brooklyn, New York, near Sheepshead Bay—an area named for the Sheepshead, a fish that can no longer be found in the waters that frame the neighborhood....
New FDA-Approved Oncology Drugs and Label Updates Between May 8, 2020, and May 8, 2021
Over the past year (May 2020–May 2021), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below. PEMBROLIZUMAB (KEYTRUDA) in...
FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma With an FGFR2 Fusion or Rearrangement
On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor infigratinib (Truseltiq) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or ...
FDA Approves Sotorasib for KRAS G12C–Mutated NSCLC
On May 28, the U.S. Food and Drug Administration (FDA) approved sotorasib (Lumakras) as the first treatment for adult patients with non–small cell lung cancer (NSCLC) whose tumors have a KRAS G12C genetic mutation and who have received at least one prior systemic therapy. This is the first approved ...
Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphoma
On February 5, 2021, lisocabtagene maraleucel was approved for the 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 lymphoma (DLBCL) not otherwise specified (including DLBCL arising from...
FDA Approves Piflufolastat F-18 Injection, a PSMA PET Imaging Agent, for the Detection of Metastatic or Recurrent Prostate Cancer
On May 27, the U.S. Food and Drug Administration (FDA) approved piflufolastat F-18 injection (Pylarify), an F-18–labeled prostate-specific membrane antigen (PSMA)-targeted positron-emission tomography (PET) imaging agent, to identify suspected metastasis or recurrence of prostate cancer. This is...
Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma
On March 26, 2021, idecabtagene vicleucel was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.1,2 Idecabtagene vicleucel is...
Fam-trastuzumab Deruxtecan-nxki for Trastuzumab-Pretreated Advanced HER2-Positive Gastric Adenocarcinoma
On January 15, 2021, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki was approved for treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.1,2 Supporting Efficacy Data...
EMPOWER-Lung 1 Trial: New Options, No New Answers
The EMPOWER-Lung 1 trial, recently reported in The Lancet and reviewed in this issue of The ASCO Post, showed an improvement in progression-free and overall survival with cemiplimab-rwlc in patients with advanced non–small cell lung cancer (NSCLC) and high PD-L1 expression (tumor proportion score...
First-Line Cemiplimab-rwlc Improves Outcomes vs Platinum-Doublet Chemotherapy in Advanced NSCLC With PD-L1 Expression ≥ 50%
As reported in The Lancet by Ahmet Sezer, MD, of Başkent University, Adana, Turkey, and colleagues, the phase III EMPOWER-Lung 1 trial has shown improved overall and progression-free survival with cemiplimab-rwlc vs platinum doublet chemotherapy among patients with advanced non–small cell lung...
FDA ODAC Meeting Focuses on ‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies
In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...
Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
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 February 26, 2021, the peptide-conjugated alkylating...
