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Showing 1001 - 1050FDA 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,...
Emerging 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...
