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Showing 1051 - 1100Emerging Data on PARP Inhibition in Prostate Cancer
Prostate cancer has lagged behind other solid tumors with regard to molecularly targeted therapy and precision medicine, with no targeted therapies approved specifically in prostate cancer, but that has changed with the recent approval in 2020 of a PARP (poly [ADP-ribose] polymerase) inhibitor for...
FDA and AACR Launch Project Livin’ Label
The American Association for Cancer Research (AACR) and the U.S. Food and Drug Administration (FDA) will collaborate on Project Livin’ Label, a new educational initiative that aims to foster broad understanding of specific oncology product labels and increase awareness of recent oncology drug FDA...
FDA Pipeline: Agents in DLBCL, SCLC, AML, and More
Recently, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions for agents to treat diffuse large B-cell lymphoma (DLBCL), small cell lung cancer (SCLC), acute myeloid leukemia (AML), biliary tract cancer, and graft-vs-host disease. Priority Review for Loncastuximab Tesirine...
FDA Approves Pralsetinib for RET-Altered Thyroid Cancers
On December 1, the U.S. Food and Drug Administration (FDA) approved pralsetinib (Gavreto) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, or for patients with RET fusion–positive thyroid cancer...
FDA Approves Gallium-68 PSMA-11 for PSMA-Targeted PET Imaging in Prostate Cancer
On December 1, the U.S. Food and Drug Administration (FDA) approved gallium-68 PSMA-11—the first drug for positron-emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Gallium-68 PSMA-11 is indicated for patients with suspected ...
FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate
The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for December 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. “In keeping with the FDA’s commitment ...
FDA Grants Accelerated Approval to Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow
On November 25, the U.S. Food and Drug Administration (FDA) granted accelerated approval to naxitamab (Danyelza) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients aged 1 year and older and adult patients with relapsed or refractory high-risk...
FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
Stephen M. Hahn, MD, Commissioner at the U.S. Food and Drug Administration (FDA), recently issued a statement regarding an important step that researchers and medical product sponsors can take to make sure clinical trials for medical products are more inclusive of multiple populations. “We have...
Venetoclax in Combination Therapy for Untreated Acute Myeloid Leukemia
On October 16, 2020, venetoclax was granted regular approval for use in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or those with comorbidities precluding intensive induction...
This Year’s FDA-ASCO Workshop Focused on Collection of Patient-Reported Tolerability Data From Clinical Trials
OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Vishal Bhatnagar, MD, Associate Director for Patient Outcomes, Bellinda King-Kallimanis, PhD, Senior Staff...
Support Builds for Anti-BCMA CAR T-Cell Therapy in Multiple Myeloma
Based on early results in clinical trials, interest in the use of chimeric antigen receptor (CAR) T-cell therapy in multiple myeloma has been high, especially for products targeting B-cell maturation antigen (BCMA). During the ASCO20 Virtual Scientific Program, further support for CAR T-cell...
Pembrolizumab in Adult and Pediatric Classical Hodgkin 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 October 14, 2020, the approval of pembrolizumab was...
Hairy Cell Leukemia Foundation and Leukemia & Lymphoma Society Join Forces
The Hairy Cell Leukemia Foundation (HCLF) and The Leukemia & Lymphoma Society (LLS) recently announced they are teaming up to support a research grants program of up to $10 million over 5 years. Their goal is to build a more comprehensive understanding of hairy cell leukemia, develop better...
Expert Point of View: Deborah B. Doroshow, MD, PhD
Invited study discussant, Deborah B. Doroshow, MD, PhD, Assistant Professor of Medicine at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, in New York, noted that the current first-line treatment paradigm for patients with advanced NSCLC and no driver mutation is based on...
Nivolumab Plus Ipilimumab in First-Line NSCLC: Two New Indications, Many More Questions
In May 2020, the combination of nivolumab and ipilimumab was approved by the U.S. Food and Drug Administration (FDA) for two separate indications in the first-line setting of advanced non–small cell lung cancer (NSCLC). One was in metastatic NSCLC with tumors that have PD-L1 expression ≥ 1% with...
Fluciclovine PET Imaging Benefits Radiotherapy Treatment Planning Compared With Conventional Imaging in Prostate Cancer
The addition of the radiotracer fluciclovine to positron-emission tomography (PET) imaging for radiotherapy treatment planning led to superior failure-free survival compared with conventional imaging in men with prostate cancer who had undergone radical prostatectomy and were experiencing biologic ...
FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for December 10, 2020, to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. “The...
Emergency Use Authorization Request to Be Submitted to FDA Today for COVID-19 Vaccine
Pfizer Inc and BioNTech SE announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the United...
Support Builds for Anti-BCMA CAR T-Cell Therapy in Multiple Myeloma
Based on early results in clinical trials, interest in the use of chimeric antigen receptor (CAR) T-cell therapy in multiple myeloma has been high, especially for products targeting B-cell maturation antigen (BCMA). During the ASCO20 Virtual Scientific Program, further support for CAR T-cell...
Novel Therapies and New Indications for Use in Treatment of Hematologic Malignancies
Daratumumab and hyaluronidase-fihj: On May 1, 2020, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. Ibrutinib: On April 21, 2020, the FDA expanded the indication of ibrutinib (Imbruvica) to include...
Novel Treatment Approaches on the Horizon in Multiple Myeloma
Clinicians who treat multiple myeloma can anticipate a host of new treatments: melflufen, cereblon E3 ligase modulators (CELMoDs), antibody-drug conjugates, bispecific antibodies, and chimeric antigen receptor (CAR) T-cell therapies. Kenneth C. Anderson, MD, FASCO, Director of the Jerome Lipper...
Novel Therapies and New Indications for Use in Treatment of Hematologic Malignancies
Venetoclax: On October 16, 2020, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older. See page 32 for more on this approval....
Hematologic Oncology Highlights 2019–2020 Almanac
The past year has seen remarkable advances in the treatment of leukemia, lymphoma, and multiple myeloma, which combined account for 9.9% of the estimated 1,806,590 new cases of cancer diagnosed in the United States and an estimated 56,840 cancer-related deaths.1 Novel therapies are providing...
Bispecific Antibodies Poised to Impact Treatment of Lymphoma and Other Blood Cancers
Studies of second-generation bispecific antibodies were among the highlights of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition. The bispecific T-cell engager blinatumomab was the first such agent to be approved by the U.S. Food and Drug Administration (FDA) in...
Chemotherapy-Free Approaches in Follicular and Mantle Cell Lymphomas
As chemotherapy and chemoimmunotherapy regimens reach their maximal impact in follicular lymphoma and mantle cell lymphoma, clinicians are turning to chemotherapy-free approaches to achieve better control, less toxicity, and (hopefully) a cure. During the ASCO20 Virtual Education Program, Sonali...
Venetoclax Combination in Newly Diagnosed AML
On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or who have comorbidities precluding...
FDA Issues Emergency Use Authorization for First COVID-19 Test for Self-Testing at Home
On November 17, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home. The Lucira COVID-19 All-In-One Test Kit, which provides rapid results, is a molecular (real-time loop mediated amplification...
FDA Pipeline: Fast Track Designations in Liver and Pancreatic Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designations to novel agents in the treatment of liver and pancreatic cancers. Fast Track Designation for SRF388 in Liver Cancer The FDA granted Fast Track designation to SRF388 for the treatment of patients with...
FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer
On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1...
Project N95 Partnership Provided ASCO Members With Access to Personal Protective Equipment
The COVID-19 pandemic has made 2020 a challenging year for everyone, including cancer care providers, many of whom have had difficulty obtaining personal protective equipment (PPE) for their patients and staff during the pandemic. To help ease this burden on its members, ASCO partnered with Project ...
Inaugural Class of FDA-AACR Oncology Educational Fellows Announced
The American Association for Cancer Research (AACR) has announced the 2020–2021 class of U.S. Food and Drug Administration (FDA)-AACR Oncology Educational Fellows. This is the first year of the fellowship, a joint initiative of the Oncology Center of Excellence at the FDA and the AACR. The...
Combination of Nivolumab and Ipilimumab for Unresectable Malignant Pleural Mesothelioma
On October 2, 2020, the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) was approved for first-line treatment of adult patients with unresectable malignant pleural mesothelioma.1-3 Supporting Efficacy Data Approval was based on findings in the open-label phase III CheckMate 743 trial...
Front-Line Avelumab Maintenance Improved Survival Across Subgroups With Advanced Urothelial Carcinoma
A strategy of front-line maintenance treatment with the PD-L1 inhibitor avelumab combined with best supportive care improved both progression-free and overall survival vs best supportive care alone across prespecified subgroups of patients with advanced or metastatic urothelial carcinoma that had...
Companion Diagnostic to Identify NTRK Fusions in Patients With Solid Tumors Eligible for Larotrectinib Treatment Approved by FDA
On October 23, 2020, the U.S. Food and Drug Administration (FDA) approved the next-generation sequencing–based FoundationOne CDx test as a companion diagnostic to identify fusions in the neurotrophic receptor tyrosine kinase (NTRK) genes NTRK1, NTRK2, and NTRK3 in DNA isolated from tumor tissue...
Committed to Excellence: Oncology Drug Development Marches on Amid a Pandemic
Instituted as part of the 21st Century Cures Act, the Oncology Center of Excellence (OCE) fosters a unified interaction between three U.S. Food and Drug Administration (FDA) centers: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and...
Richard Pazdur, MD, Awarded the Simon M. Shubitz Cancer Prize and Lectureship
For more than 4 decades, the University of Chicago Cancer Research Foundation’s Simon M. Shubitz Cancer Prize and Lectureship has honored an internationally renowned individual for his or her exceptional contributions to cancer research and clinical care. The recipient of this year’s award is...
FDA Expands Approval of Companion Diagnostic for Olaparib in Prostate Cancer
On November 9, the U.S. Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to be used as a companion diagnostic for olaparib. As a companion diagnostic, FoundationOne Liquid CDx will use a blood-based biopsy to identify patients with BRCA1, BRCA2, and/or ATM alterations and...
FDA Approves Companion Diagnostic for Three Targeted Therapies for Advanced Ovarian, Breast, and Non–Small Cell Lung Cancers
On October 27, 2020, the U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx test for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for alpelisib...
FDA Pipeline: Priority Reviews in NSCLC, Gastric Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a PD-1 inhibitor for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC), and also granted Priority Review to a HER2-directed antibody-drug conjugate for patients with...
Study Finds Further Efforts Needed for Inclusion of Underrepresented Populations in Radiotherapy Clinical Trials
A new study finds that the racial composition of clinical trials involving radiation therapy does not match that of the U.S. population. Examining trials from the past 23 years, researchers found that roughly 12% of trial participants were Black, which is less than the 13% population composition of ...
FDA Approves Companion Diagnostic for Three Targeted Therapies for Advanced Ovarian, Breast, and Non–Small Cell Lung Cancers
On October 27, the U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx test for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for alpelisib (Piqray) in ...
Fluciclovine PET Imaging vs Conventional Imaging in Prostate Cancer
The addition of the radiotracer fluciclovine to positron-emission tomography (PET) imaging for treatment planning led to superior failure-free survival compared with conventional imaging in men with prostate cancer who had undergone radical prostatectomy and were experiencing biologic recurrence of ...
Targeted Inhibitor of Mutant KRAS Gene Shows Activity in Early Trial
Adagrasib (MRTX849), a novel agent that targets a mutated form of the KRAS gene—the most commonly altered oncogene in human cancers, and one long considered “undruggable”—caused tumor shrinkage in most patients in a clinical trial, with manageable side effects, researchers reported at the 32nd...
Companion Diagnostic to Identify NTRK Fusions in Patients With Solid Tumors Eligible for Treatment With Larotrectinib Approved by the FDA
On October 23, the U.S. Food and Drug Administration (FDA) approved the next-generation sequencing–based FoundationOne CDx test as a companion diagnostic to identify fusions in the neurotrophic receptor tyrosine kinase (NTRK) genes NTRK1, NTRK2, and NTRK3 in DNA isolated from tumor tissue specimens ...
Emily Whitehead, Early Recipient of CAR T-Cell Therapy for ALL, Celebrates 8 Years Cancer-Free
Among the success stories in the treatment of acute lymphoblastic leukemia (ALL) in children and young adults is the development of chimeric antigen receptor (CAR) T-cell therapy. The field of cellular immunotherapy was still in its infancy in 2012 when Emily Whitehead, then 7, became the first...
Dana-Farber Announces Center for Salivary and Rare Head and Neck Cancers
Dana-Farber Cancer Institute has launched the Center for Salivary and Rare Head and Neck Cancers to treat patients with rare and occasionally aggressive cancers arising from the head and neck. The Center is among the first in the country specifically dedicated to the care and therapeutic research...
FDA Awards Six Grants to Fund New Clinical Trials of Medical Products for Treatment of Rare Diseases
The U.S. Food and Drug Administration (FDA) announced it has awarded six new clinical trial research grants to principal investigators from academia and industry, totaling more than $16 million over the next 4 years. These grants, awarded through the Congressionally funded Orphan Products Grants...
Thinking Out of the Box to Advance the Management of Chronic Graft-vs-Host Disease
Over the past decade, the field of allogeneic hematopoietic cell transplantation has made great strides, evolving into a curative procedure for blood cancers that once were almost always fatal. However, chronic graft-vs-host disease, whose biologic etiology remains unclear, continues to be the...
Olaparib Improves Outcomes in Metastatic Castration-Resistant Prostate Cancer With BRCA1/2 Alterations
The PARP inhibitor olaparib reduced the risk of death by 31% compared with a second hormonal treatment (enzalutamide or abiraterone) in men with metastatic castration-resistant prostate cancer characterized by BRCA1, BRCA2, or ATM mutations, in the final analysis of the phase III PROfound trial...
Co-Leader of Immunotherapy Trial Reflects on ‘Practice-Changing’ Results in Advanced Bladder and Other Urinary Tract Cancers
In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD,...
