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Showing 1001 - 1050Novel 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...
FDA Grants Accelerated Approval to Daratumumab Plus Hyaluronidase-fihj for Newly Diagnosed Light Chain Amyloidosis
On January 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to daratumumab plus hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis. ANDROMEDA Trial Efficacy was evaluated in ...
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Previously Treated Patients With HER2-Positive Gastric Cancers
On January 15, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen....
FDA Pipeline: Two Fast Track Designations for Cavrotolimod in Nonmelanoma Skin Cancers
The U.S. Food and Drug Administration (FDA) has granted two Fast Track designations to cavrotolimod (AST-008). The designations include cavrotolimod in combination with anti–PD-1 therapy for the treatment of patients with locally advanced or metastatic Merkel cell carcinoma refractory to prior...
FDA Approves Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive ALCL
On January 14, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori) for pediatric patients aged 1 year and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been ...
Sean Khozin, MD, MPH, Named New Chief Executive Officer of ASCO’s CancerLinQ
Sean Khozin, MD, MPH, has been named Chief Executive Officer of CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO. A board-certified oncologist, physician-scientist, and data science expert, Dr. Khozin is a proven leader and visionary in deploying cutting-edge data science and technology...
FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health-Care Providers and Clinical Laboratory Staff
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health-care providers that it is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests....
FDA Pipeline: Two Reviews in NSCLC, Plus Prescribing Information Update for Darolutamide
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to lorlatinib in ALK-positive non–small cell lung cancer (NSCLC) and Breakthrough Therapy designation to the combination of tiragolumab plus atezolizumab in NSCLC with high PD-L1 expression. The FDA also updated the...
Facebook Posts and the Spread of Incorrect Information About Perceived Risks of HPV Vaccination
The human papillomavirus (HPV) is the most common sexually transmitted infection in the United States, according to the Centers for Disease Control and Prevention (CDC). HPV is associated with health problems—including cancers—but a vaccine for the virus has been available since 2006. The CDC...
Subcutaneous Fixed-Dose vs Intravenous Pertuzumab/Trastuzumab for HER2-Positive Early Breast Cancer
As reported in The Lancet Oncology by Tan et al, the phase III FeDeriCa trial showed comparable pharmacokinetics and pathologic complete response rates with a subcutaneous (SC) fixed-dose combination of pertuzumab and trastuzumab vs the same combination administered intravenously (IV)—both given...
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
On January 4, U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, MD, and Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks, MD, PhD, issued the following statement on FDA-authorized dosing schedules for each COVID-19 vaccine. Two different mRNA...
Nivolumab Indication in Small Cell Lung Cancer Withdrawn in U.S. Market
On December 29, Bristol Myers Squibb issued the following statement on nivolumab’s small cell lung cancer (SCLC) indication in the United States. In 2018, nivolumab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of patients with SCLC whose disease...
FDA Issues Emergency Use Authorization for Second COVID-19 Vaccine
On December 18, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the second vaccine for the prevention of COVID-19 caused by SARS-CoV-2. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the United States for use in...
Pembrolizumab Plus Chemotherapy for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer
On November 13, 2020, pembrolizumab (Keytruda) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer with tumors expressing PD-L1 (Combined ...
FDA Approves Adjuvant Osimertinib for EGFR-Mutated NSCLC
On December 18, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as...
Intratumoral Injections May Boost Neoadjuvant Response in Resectable Melanoma
Studies reported at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting, which was held virtually, showed promise for the use of intratumoral injections of novel immunotherapies in treating advanced, resectable melanoma. In the 3-year interim analysis of a global phase II randomized...
Pralsetinib for RET-Altered Thyroid Cancers
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 December 1, 2020, pralsetinib (Gavreto) was granted...
Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow
On November 25, 2020, naxitamab-gqgk (Danyelza) was granted accelerated approval for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone...
2020 FDA Approvals of Drugs for Cancer Treatment
Over the past year (January to December 2020), the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for older therapeutic agents used in oncology and hematology. A brief review of new approvals appears here. For complete prescribing information for ...
FDA Approves Selinexor for Refractory or Relapsed Multiple Myeloma
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. The FDA granted selinexor accelerated...
FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer
Today, the U.S. Food and Drug Administration (FDA) approved relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer. “Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require...
FDA Approves Rituximab-arrx, a Biosimilar to Rituximab
On December 17, the U.S. Food and Drug Administration (FDA) approved rituximab-arrx (Riabni), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener's granulomatosis), and...
FDA Approves Margetuximab-cmkb Plus Chemotherapy for Previously Treated Patients With Metastatic HER2-Positive Breast Cancer
On December 16, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb (Margenza) 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...
FDA Authorizes Antigen Test as First Over-the-Counter, Fully At-Home Diagnostic Test for COVID-19
On December 15, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter, fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral-flow antigen test, a type of test that runs a liquid sample along a...
FDA Issues Emergency Use Authorization for First COVID-19 Vaccine
On December 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of COVID-19 caused by SARS-CoV-2 in individuals aged 16 and older. The EUA allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United...
Project Orbis: Partnering With International Regulatory Agencies to Bring Earlier Global Access to Novel Cancer Treatments
OCE Insights is an occasional department 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, Preeti Narayan, MD, a medical oncologist and clinical reviewer on the Breast and Gynecologic Disease Team,...
