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Showing 951 - 1000Increase in Breast Cancer Diagnoses After Pandemic-Related Screening Interruptions
More than a year into the COVID-19 pandemic, researchers are beginning to examine the effects of the virus in the larger health-care sphere. This week, we review a report on an observed increase in breast cancer diagnoses in Italy after pandemic-related screening interruptions. We also discuss two...
Repurposing Available Drugs for COVID-19: An Ongoing Initiative
As of this writing, no drugs have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19, although several have received emergency use authorization and many others are being used off-label during the pandemic. In addition to searching for novel therapies, David...
FDA Approves Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma
On March 10, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. TIVO-3 Efficacy was evaluated in TIVO-3 (ClinicalTrials.gov...
ASCO and Friends of Cancer Research Recommend Expanding Patient Access to Cancer Clinical Trials by Further Broadening Eligibility Criteria
ASCO and Friends of Cancer Research (Friends) jointly issued new recommendations to further efforts to broaden eligibility criteria in cancer clinical trials with the goal of making clinical trials more accessible to patients.1 The joint recommendations are detailed in a series of articles...
Kratom
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Yen Nien Hou, PharmD, DipIOM, LAc, and Jyothirmai Gubili, MS, focus on...
Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive Anaplastic Large Cell Lymphoma
On January 14, 2021, crizotinib was approved for treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.1,2 The safety and efficacy of crizotinib have not been established in older...
Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations
On February 3, 2021, tepotinib was granted accelerated approval for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.1,2 Supporting Efficacy Data Approval was supported by findings from the...
Atezolizumab’s Indication in Previously Treated Metastatic Bladder Cancer Is Withdrawn
Genentech, a member of the Roche Group, announced on March 8 that the company is voluntarily withdrawing the U.S. indication for atezolizumab (Tecentriq) in patients with prior platinum-treated metastatic urothelial carcinoma. This decision was made in consultation with the U.S. Food and Drug...
FDA Grants Accelerated Approval to Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma
On March 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (Yescarta) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. ZUMA-5 Approval in follicular lymphoma was based on a...
Recent Regulatory Decisions in Multiple Myeloma and Lung Cancer
This week, we’re discussing recent regulatory decisions, ranging from FDA approvals in multiple myeloma and non–small cell lung cancer to the withdrawal of a widely used drug’s indication for small cell lung cancer.
FDA Pipeline: Designations in Ovarian, Head/Neck, and Thyroid Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a novel immunotherapy for the treatment of ovarian cancer as well as Breakthrough Therapy designation to treatments for HRAS-mutant head and neck squamous cell carcinoma and previously treated thyroid cancer....
FDA Approves Lorlatinib for Metastatic ALK-Positive NSCLC
On March 3, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. The FDA also approved the...
Pembrolizumab's Indication in Small Cell Lung Cancer Is Withdrawn
On March 1, Merck announced the company is voluntarily withdrawing the U.S. indication for pembrolizumab (Keytruda) for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The ...
ASCO’s Road to Recovery Report Outlines Lessons Learned From the COVID-19 Pandemic to Improve Oncology Care
In 2020, ASCO established the Steering Group on Cancer Care Delivery and Research in a Post-Pandemic Environment to evaluate the changes made in oncology care delivery, clinical research, and regulatory oversight in response to the COVID-19 pandemic as well as to make recommendations on how to...
FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
On February 27, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of COVID-19. The EUA allows the Janssen COVID-19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older. The FDA...
FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
On February 26, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is...
EMPOWER-Lung 1: First-Line Cemiplimab-rwlc vs Platinum-Doublet Chemotherapy in Advanced NSCLC With PD-L1 Expression ≥ 50%
As reported in The Lancet by Sezer et al, 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 cancer (NSCLC) with PD-L1 expression on ≥ 50% of tumor cells...
New Report Reviews Methods for Reducing Waste, Improving Efficiency With Expensive Injectable Medications
Every year, significant amounts of drugs left over and unused from single-dose vials are discarded, but because of the way drugs are priced and paid for in the United States, the cost of the discarded amount cannot be recouped, according to a new congressionally mandated report from the National...
In Case You Missed It: Brief Highlights From ASH 2020
In case you missed these while attending the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, below is a sampler of highlights that were not included in our first round of meeting coverage. Many of these reports are on early-phase clinical trials of agents that may raise...
Novel Approaches in Chronic Lymphocytic Leukemia
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 therapeutic approaches in chronic lymphocytic leukemia (CLL). For full...
B-Cell and T-Cell 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 the assessment and treatment of patients with B-cell and T-cell non-Hodgkin...
How the COVID-19 Pandemic Can Help Improve Cancer Research
The ripple effects of the coronavirus pandemic have been felt in every area of health care. In our medical specialty, oncology, clinical trials of new treatments were upended by COVID-19. In the early months of the pandemic, widespread interruptions in trial enrollment prevented some patients...
Phase II CodeBreak 100 Validates Benefit of KRAS Inhibitor Sotorasib in Advanced Lung Cancer
The registrational phase II CodeBreak 100 trial has validated the power of KRAS inhibition with sotorasib (AMG 510) in advanced non–small cell lung cancer (NSCLC).1 In a follow-up to the groundbreaking findings of the phase I trial, the phase II cohort has now shown a durable response rate of...
FDA Approves Cemiplimab-rwlc for Patients With NSCLC and High PD-L1 Expression
On February 22, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] > 50%) as determined by an FDA-approved...
New Recommendations Aim to Eliminate Racial Disparities in Multiple Myeloma Therapies and Trials
Recommendations designed to address the underrepresentation of Black patients in clinical trials for multiple myeloma were recently released. Details about the initiative, published by Gormley et al in Blood Cancer Discovery, form a road map for designing multiple myeloma clinical trials to...
Novel Therapies and New Indications for Use in Treatment of Hematologic Malignancies
Selinexor: On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Venetoclax: On October 16,...
FDA Pipeline: Priority Reviews in KRAS G12C–Mutated NSCLC, Non–Muscle-Invasive Bladder Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for KRAS G12C–mutated non–small cell lung cancer (NSCLC) and high-risk, bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer. A new drug application for a therapy for Waldenström’s...
FDA Approves Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression in Adults Being Treated for SCLC
On February 12, the U.S. Food and Drug Administration (FDA) approved trilaciclib (Cosela) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (SCLC)....
FDA Pipeline: Breakthrough Designations in CML and for Cachexia, EUA for COVID-19
Recently, the U.S. Food and Drug Administration (FDA) issued a Breakthrough Therapy designation to asciminib for chronic myeloid leukemia (CML); a Breakthrough Device designation to an assay designed to help select patients with cachexia for treatment with an investigational therapeutic; and an...
Nivolumab Plus Cabozantinib Shows Sustained Benefits as First-Line Treatment for Advanced RCC
New analyses from the phase III CheckMate 9ER trial are being presented at the 2021 Genitourinary Cancers Symposium. These new findings demonstrate clinically meaningful, sustained efficacy benefits as well as quality-of-life improvements with the combination of nivolumab and cabozantinib compared...
FDA Approves Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
On February 9, the U.S. Food and Drug Administration (FDA) granted regular approval to cemiplimab-rwlc (Libtayo) for patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. The FDA also granted...
Looking Back on the 40-Year Career of Richard L. Schilsky, MD, FACP, FSCT, FASCO
The medical career of Richard L. Schilsky, MD, FACP, FSCT, FASCO, spans more than 4 decades and includes a roster of nearly unprecedented accomplishments in patient care, research, and mentoring. He has held leadership positions in academia, first at the University of Chicago, where he spent the...
Janet Woodcock, MD, Named Acting FDA Commissioner
Janet Woodcock, MD, current Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), has been named acting FDA Commissioner, according to a report published in The New York Times.1Stephen M. Hahn, MD, who had been FDA Commissioner since December 17,...
Lisocabtagene Maraleucel Approved by FDA for Patients With Relapsed or Refractory Large B-Cell Lymphoma
On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi) 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...
FDA Grants Accelerated Approval to Umbralisib for Treatment of Marginal Zone and Follicular Lymphomas
On February 5, the U.S. Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq), a kinase inhibitor including PI3K-delta and CK1-epsilon, for the following indications: Adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior...
FDA Update: Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate, Statement on Product Development to Address Virus Variants
On February 4, the U.S. Food and Drug Administration (FDA) announced the scheduling of a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the request for emergency use authorization for a COVID-19 vaccine from Janssen Biotech Inc. Additionally, Acting...
FDA Grants Accelerated Approval to Tepotinib for Patients With Metastatic NSCLC and MET Exon 14–Skipping Alterations
On February 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations. VISION Trial Efficacy was...
Prevalence of KRAS G12C Mutations Across Different Populations
This week, we'll discuss the findings of a study that examined the prevalence of KRAS G12C mutations across different populations. Then, we'll hear recent news about FDA oncology drug approvals in the month of January.
‘State of Tobacco Control’ 2021 Report Says Ending Tobacco Use Is Critical, Especially During the COVID-19 Pandemic
Even amid the COVID-19 pandemic, tobacco use remains a serious public health threat. In addition to tobacco-related death and disease, smoking also increases the risk of the most severe impacts of COVID-19. The American Lung Association has released its 19th annual “State of Tobacco Control”...
FDA Pipeline: Priority Reviews for Immunotherapies in Gastric Cancers, Anal Cancer
The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...
Osimertinib in Adjuvant Therapy for NSCLC With EGFR Mutations
On December 18, 2020, osimertinib was approved for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) with tumors with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Supporting...
Expert Point of View: Yuan Yuan, MD, PhD, and Elizabeth Mittendorf, MD, PhD
Yuan Yuan, MD, PhD, a medical oncologist at City of Hope, Duarte, California, weighed in on the KEYNOTE-355 findings. “The study presented by Dr. Rugo on KEYNOTE-355 reconfirms the utility of adding immune checkpoint inhibitorsto chemotherapy as front-line treatment for metastatic triple-negative...
KEYNOTE-355: Pembrolizumab Plus Chemotherapy Improves Progression-Free Survival in PD-L1–Enriched Advanced Triple-Negative Breast Cancer
Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...
Relugolix for Advanced Prostate Cancer
On December 18, 2020, relugolix was approved for the treatment of adult patients with advanced prostate cancer. Relugolix is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist to be approved in this setting.1,2 Supporting Efficacy Data Approval was based on findings in the...
Selinexor in Relapsed or Refractory Multiple Myeloma
On December 18, 2020, selinexor was approved for use in combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma who have received at least one prior therapy.1,2 Selinexor received accelerated approval in 2019 for use in combination with dexamethasone for...
Chronic Graft-vs-Host Disease: Future Directions in Treatment
Hematopoietic stem cell transplantation (HSCT) has improved survival rates for several hematologic malignancies, but as the number of transplants continues to rise, community oncologists are evaluating more posttransplant complications in the clinics. The ASCO Post spoke with two of the principals...
Margetuximab-cmkb for Previously Treated Metastatic HER2-Positive Breast Cancer
On December 16, 2020, margetuximab-cmkb (margetuximab) was approved for use in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.1,2...
FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma
On January 22, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) and cabozantinib (Cabometyx) as first-line treatment for patients with advanced renal cell carcinoma. CheckMate 9ER Efficacy was evaluated in CheckMate 9ER, a randomized, open-label trial in...
Janet Woodcock, MD, Named Acting FDA Commissioner
Janet Woodcock, MD, current Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), has been named acting FDA Commissioner, according to a report published in The New York Times. Stephen M. Hahn, MD, who had been FDA Commissioner since December 17,...
Empowering the FDA to Require Dose Optimization of All New Oncology Drugs
The vast majority of drugs used outside of oncology are evaluated in randomized dose-ranging trials to optimize the therapeutic index prior to the pivotal phase III trial. No one would think of dosing a statin or an antibiotic at the highest dose patients could tolerate, especially if that dose...
