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Showing 551 - 600FDA Approves New Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn
On November 18, the U.S. Food and Drug Administration (FDA) approved a new Monday/Wednesday/Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings and 50 mg/m2...
Selpercatinib Approved for Advanced RET Fusion–Positive Solid Tumors and Advanced RET Fusion–Positive NSCLC
On September 21, 2022, selpercatinib was granted accelerated approval for adults with locally advanced or metastatic solid tumors with RET gene fusion whose disease has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.1 On the same day,...
FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
On November 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received...
FDA Approves Tremelimumab in Combination With Durvalumab and Platinum-Based Chemotherapy for Metastatic NSCLC
On November 10, the U.S. Food and Drug Administration (FDA) approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) and platinum-based chemotherapy for adult patients with metastatic non–small cell lung cancer (NSCLC) with no EGFR mutations or ALK genomic tumor aberrations. ...
FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma
On November 10, the U.S. Food and Drug Administration (FDA) approved the CD30-directed antibody-drug conjugate brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged 2 years and older with previously...
Study Sheds Light on Need for Optimal Dosing Standards for Patients With Metastatic Cancer
A new study, published recently in JCO Oncology Practice, found that oncologists have different perspectives on how to select starting doses for patients with metastatic cancer.1 The study shared findings from a 2021 international survey of 367 medical oncologists who treat patients with metastatic ...
ASCO Treatment Guidance for Metastatic Castration-Resistant Prostate Cancer Updated to Include LuPSMA
An updated ASCO guideline recommends lutetium-177–labeled PSMA-617 (LuPSMA), a targeted radioligand therapy, for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with one prior line of androgen receptor pathway...
I’ve Had Two Primary Lung Cancers, and They Haven’t Defeated Me
I don’t know why I am so susceptible to developing lung cancer. Since 2014, I have been diagnosed with both non–small cell lung cancer (NSCLC) and small cell lung cancer, each occurring in my right lung. I have also been diagnosed with precancerous colon polyps, which necessitated invasive surgery. ...
The Evolving Role of PI3K Inhibitors in Double-Refractory CLL
The treatment paradigm for chronic lymphocytic leukemia (CLL) continues to evolve in the first-line setting and beyond, with the availability of Bruton’s tyrosine kinase (BTK) inhibitors, the BCL2 inhibitor venetoclax, and novel combinations of these agents with anti-CD20 monoclonal antibodies....
Sotorasib: A New Standard of Care for Second- or Third-Line Treatment of KRAS G12C–Mutated NSCLC?
The KRAS G12C inhibitor sotorasib doubled the rate of progression-free survival at 12 months and reduced the risk of disease progression or death by 34% compared with standard second-line docetaxel for patients with previously treated non–small cell lung cancer (NSCLC) and KRAS G12C mutations....
‘TRANSFORMING’ Our Thinking About Second-Line Therapy for High-Risk Large B-Cell Lymphoma: Bring in the CARs
As reported in The Lancet by Kamdar et al,1 and summarized in this issue of The ASCO Post, the international phase III TRANSFORM trial was completed in 184 patients with primary refractory or early (≤ 12 months) relapsed large B-cell lymphoma (LBCL). Patients were randomly assigned to receive...
FDA Approves Cemiplimab-rwlc in Combination With Platinum-Based Chemotherapy for NSCLC
On November 8, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adult patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. Study 16113 Efficacy was...
Preliminary Results From ARROS-1 Phase I Clinical Trial Suggest That NVL-520 May Be Well Tolerated and Active in NSCLC
Preliminary data from a phase I clinical trial of the ROS1 inhibitor NVL-520 to treat patients with non–small cell lung cancer (NSCLC) and other solid tumors suggested that it may have the potential to both halt tumor growth by inhibiting a cancer-causing gene change and reach cancer cells within...
Expert Point of View: Robin Kate Kelley, MD
Robin Kate Kelley, MD, Professor of Clinical Medicine at the University of California, San Francisco, was invited to discuss the results of LEAP-002.1 She said the main take-away is that lenvatinib monotherapy is active as a preferred first-line agent for fit patients who have contraindications to ...
FDA Approves Oral MEK Inhibitor Cobimetinib for Histiocytic Neoplasms
The U.S. Food and Drug Administration (FDA) has approved cobimetinib (Cotellic), an oral inhibitor of MEK1 and MEK2, for the treatment of adult patients with the family of blood diseases known as histiocytic neoplasms. These diseases include Erdheim-Chester disease, Rosai-Dorfman disease, and...
Sotorasib: A New Standard of Care for Second- or Third-Line Treatment of KRAS G12C–Mutated NSCLC?
The KRAS G12C inhibitor sotorasib doubled the rate of progression-free survival at 12 months and reduced the risk of disease progression or death by 34% compared with standard second-line docetaxel for patients with previously treated non–small cell lung cancer (NSCLC) and KRAS G12C mutations....
FDA Approvals in Hepatocellular Carcinoma and Multiple Myeloma
On this episode, we’re covering two recent approvals from the U.S. Food and Drug Administration (FDA): one in unresectable hepatocellular carcinoma, and one in relapsed or refractory multiple myeloma.
AACR and ASCO Release Joint Policy Statement on Electronic Nicotine Delivery Systems
The American Association for Cancer Research (AACR) and ASCO have released a joint policy statement outlining the latest research on the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) and recommendations for regulating these products to protect public health. The...
FDA Approves Teclistamab-cqyv for Relapsed or Refractory Multiple Myeloma
On October 25, the U.S. Food and Drug Administration (FDA) granted accelerated approval to teclistamab-cqyv (Tecvayli), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four...
FDA Approves Tremelimumab Plus Durvalumab for Adult Patients With Unresectable HCC
On October 21, the U.S. Food and Drug Administration (FDA) approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The novel dose and schedule of the...
Breast Cancer 2021–2022 Almanac
The past year has seen an unprecedented number of practice-changing advances across all three major breast cancer subtypes. For patients with early-stage triple-negative breast cancer, neoadjuvant chemotherapy plus pembrolizumab firmly entered the standard of care based on improvements in...
Long-Term Follow-up of monarchE: Benefit of Abemaciclib Plus Endocrine Therapy Maintained in Early High-Risk Breast Cancer
Longer-term follow-up of the global phase III monarchE trial showed an increasing benefit for adding abemaciclib to endocrine therapy in the adjuvant treatment of early high-risk hormone receptor–positive, HER2-negative breast cancer, regardless of Ki67 index. The latest findings were reported at a ...
Recent FDA Approvals in Breast Cancer
In the past year, the U.S. Food and Drug Administration (FDA) approved four treatment options for patients with breast cancer, which are summarized herein. T-DXd for HER2-Low Breast Cancer On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu; T-DXd) for adult patients with...
Highlights From the IASLC 2022 World Conference on Lung Cancer
Over the past few years, we have seen rapid and dramatic transformation in the therapeutic landscape of non–small cell lung cancer (NSCLC). We have had multiple new targeted therapies for newer targets (previously undruggable targets) and better diagnostic strategies to workup patients to realize...
Extended-Interval vs Standard-Interval Dosing of Single-Agent Pembrolizumab
In a retrospective cohort study performed in U.S. veterans reported in JAMA Oncology, Strohbehn et al found that a minority of patients receiving singe-agent pembrolizumab for cancer received the extended-interval dosing of 400 mg every 6 weeks. Analysis of efficacy measured as the time to...
FDA Grants Accelerated Approval to Futibatinib for Previously Treated Patients With FGFR2-Mutated Cholangiocarcinoma
On September 30, the U.S. Food and Drug Administration (FDA) granted accelerated approval to futibatinib (Lytgobi) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or...
FDA Approves Biosimilar Bevacizumab-adcd for the Treatment of Six Types of Cancer
On September 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-adcd (Vegzelma), a biosimilar to bevacizumab (Avastin), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC); recurrent...
Patients With Multiple Myeloma May Face CAR T-Cell Shortages
From microchips to automobiles, people in the United States are experiencing shortages of all kinds of products, and oncology treatments are no exception. In particular, shortages related to chimeric antigen receptor (CAR) T-cell therapy have been reported, most acutely, for B-cell maturation...
Trastuzumab Deruxtecan for Advanced HER2-Mutant NSCLC
On August 11, 2022, fam-trastuzumab deruxtecan-nxki was granted accelerated approval for unresectable or metastatic non–small cell lung cancer (NSCLC) with tumors that have activating HER2 mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test and who have received a...
AACR Cancer Progress Report 2022 Shows Cancer Mortality Rates Continue to Decline, but Challenges Remain
Advances in more effective treatment and early detection diagnostics, coupled with reductions in smoking rates, have resulted in a 32% decline in cancer mortality in the United States since 1991, translating into nearly 3.5 million lives saved, according to the newly released American Association...
Selpercatinib Approved for Locally Advanced or Metastatic RET Fusion–Positive Solid Tumors
On September 21, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion and disease progression on or following prior systemic...
FDA Approves Selpercatinib for Locally Advanced or Metastatic RET Fusion–Positive NSCLC
On September 21, the U.S. Food and Drug Administration (FDA) granted regular approval to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a RET gene fusion (as detected by an FDA-approved test). The FDA also approved the Oncomine ...
Neoadjuvant Atezolizumab May Be Safe, Effective Option for Localized Non–Small Cell Lung Cancer
New data show that the immuno-oncology drug atezolizumab may be a safe and effective treatment for patients with stage IB to IIIB non–small cell lung cancer (NSCLC) prior to surgery, according to a study led by researchers with The Ohio State University Comprehensive Cancer Center–Arthur G. James...
FDA Approves Sodium Thiosulfate to Reduce the Risk of Ototoxicity Associated With Cisplatin
On September 20, the U.S. Food and Drug Administration (FDA) approved sodium thiosulfate (Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized (nonmetastatic) solid tumors. Efficacy was evaluated in two multicenter,...
Neoadjuvant Cemiplimab in Patients With Stage II to IV Cutaneous Squamous Cell Carcinoma
In an international, multicenter phase II clinical trial, 63.3% of patients with stage II to IV cutaneous squamous cell carcinoma saw their tumors nearly or completely eradicated when treated with the anti–PD-1 agent cemiplimab-rwlc before surgery. The results were presented by Gross et al at the...
TROPiCS-02 Update: Sacituzumab Govitecan Improves Overall Survival in Previously Treated Patients With Hormone Receptor–Positive, HER2-Negative Breast Cancer
An overall survival benefit has now emerged for sacituzumab govitecan-hziy in patients with previously treated hormone receptor–positive/HER2-negative locally recurrent inoperable or metastatic breast cancer, according to a planned second interim analysis of the phase III TROPiCS-02 trial. These...
FDA Approves Eflapegrastim-xnst Injection for Chemotherapy-Induced Neutropenia
On September 9, the U.S. Food and Drug Administration (FDA) approved eflapegrastim-xnst injection (Rolvedon)—a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation—to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with...
Bispecific Antibodies and the Dawn of a New Era in Treatment of Multiple Myeloma
“I think the biggest innovations of the 21st century will be at the intersection of biology and technology. A new era is beginning!” —Steve Jobs Relapsed and refractory multiple myeloma remains a treatment challenge. Promising responses have been demonstrated with bispecific antibodies, with a...
ASCO Updated Guideline of Biomarkers in Metastatic Breast Cancer Supports PIK3CA, BRCA1/2, PD-L1 Testing
ASCO has issued a new practice guideline update on the use of biomarkers in the management of metastatic breast cancer.1 The updated guideline revisits recommendations from the 2015 guideline and addresses topics that have emerged since then in the move toward personalized medicine in metastatic...
Companion Diagnostic to Identify Patients With Endometrial Cancer Eligible for Pembrolizumab Therapy Approved by the FDA
On August 11, 2022, Roche announced the U.S. Food and Drug Administration (FDA) approval of a label expansion for the Ventana MMR RxDx Panel. The Ventana MMR RxDx Panel is the first immunohistochemistry companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA ...
Wall Street Doesn’t Believe in This Target
March 2, 2009. Just published in the Journal of Clinical Investigation.1 And we even got the cover. Twists and turns of heat shock protein-90 (Hsp90), the chaperone, the evolutionary capacitor. Great name and important cancer target. People smiled when I talked about this at the Hsp90 conference....
Postmarketing Colitis Cases May Be Associated With Alpelisib Use
In a research letter in JAMA Oncology, Sullivan et al described details of postmarketing cases of noninfectious colitis in patients with breast cancer reported to the U.S. Food and Drug Administration that were considered possibly or probably related to alpelisib treatment. Key Findings A total of...
FDA Approves Durvalumab-Based Combination for Locally Advanced or Metastatic Biliary Tract Cancer
On September 2, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. TOPAZ-1 Efficacy was evaluated in TOPAZ-1 (ClinicalTrials.gov identifier:...
FDA Approval of Pemigatinib and Update From the STAMPEDE Trial
On this episode, we’re covering the U.S. Food and Drug Administration (FDA) approval of pemigatinib for patients with myeloid or lymphoid neoplasms and an FGFR1 rearrangement. We’ll also discuss a long-term update from the STAMPEDE trial of radiotherapy in prostate cancer.
FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer
On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth...
FDA Approves Pemigatinib for Patients With Myeloid/Lymphoid Neoplasms and FGFR1 Rearrangement
On August 26, the U.S. Food and Drug Administration (FDA) approved pemigatinib (Pemazyre), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. Myeloid/lymphoid neoplasms with...
MRI-Guided Ultrasound Focal Therapy May Delay or Avoid Prostatectomy or Radiotherapy in Patients With Intermediate-Risk Prostate Cancer
MRI-guided focused ultrasound focal therapy produced “a high degree of success” and “a low rate of genitourinary adverse events” when used to treat select patients with intermediate-grade prostate cancer, Behfar Ehdaie, MD, MPH, and colleagues reported in The Lancet Oncology.1 Dr. Ehdaie is...
FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-vs-Host Disease
On August 24, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for pediatric patients aged at least 1 year with chronic graft-vs-host disease after failure of one or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. iMAGINE Trial...
FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients With Beta-Thalassemia Who Require Regular Blood Transfusions
On August 17, the U.S. Food and Drug Administration (FDA) approved betibeglogene autotemcel (Zynteglo), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. “[This] approval is an important...
FDA Grants Accelerated Approval to Trastuzumab Deruxtecan for HER2-Mutant NSCLC
On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 mutations, as detected by an...
