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Showing 551 - 600FoundationOne Liquid CDx Receives FDA Approval as a Companion Diagnostic for Entrectinib
On January 4, the U.S. Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to be used as a companion diagnostic to identify patients with ROS1-positive non–small cell lung cancer (NSCLC) or NTRK fusion–positive solid tumors who do not have a tissue sample available and may be...
FDA Approves Mosunetuzumab-axgb, a First-in-Class Bispecific Antibody, in Relapsed or Refractory Follicular Lymphoma
On December 22, the U.S. Food and Drug Administration (FDA) approved mosunetuzumab-axgb (Lunsumio) for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Mosunetuzumab-axgb is a CD20/CD3 T-cell–engaging bispecific antibody and...
AACR and ASCO Release Joint Policy Statement on Electronic Nicotine Delivery Systems
The American Association for Cancer Research (AACR) and ASCO recently 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...
Sotorasib Shows Clinically Meaningful Activity Among Patients With KRAS G12C–Mutated Advanced Pancreatic Cancer
The KRAS G12C inhibitor sotorasib demonstrated clinically meaningful anticancer activity with an acceptable safety profile in heavily pretreated patients with KRAS G12C–mutated metastatic pancreatic cancer, accordi�ng to a novel study published by Strickler et al in The New England Journal of...
Mirvetuximab Soravtansine for FRɑ-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted mirvetuximab soravtansine-gynx accelerated approval for patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three...
From the Clinic to the Lab: Overcoming Resistance to Immune Checkpoint Therapy
As a result of breakthroughs in immune checkpoint inhibitors over the past decade, immunotherapy has joined surgery, radiation therapy, and chemotherapy as one of the pillars of cancer treatment. However, nearly half of patients still do not benefit from immune checkpoint blockade. During the 2022...
FDA Approves FoundationOne Liquid CDx as a Companion Diagnostic for a Certain Group of Tyrosine Kinase Inhibitors
On December 21, Foundation Medicine, Inc, announced that the U.S. Food and Drug Administration (FDA) approved its FoundationOne Liquid CDx as a companion diagnostic to identify patients with non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R substitutions...
FDA Approves Pafolacianine to Aid Lung Cancer Surgery
The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in lung cancer surgery. This injectable diagnostic binds to cancerous tissue and glows when stimulated by near-infrared light, making it easier for surgeons to remove tumors...
Understanding the Health Provisions in the Inflation Reduction Act and Their Implications for Oncology Care
The Inflation Reduction Act of 2022, signed into law on August 16, 2022, contains several important provisions regarding health care and drug pricing.1 In this article, I provide an overview of the legislation’s implications for oncology care, focusing on its provisions concerning drug price...
FDA Approves First Gene Therapy for High-Risk Non–Muscle-Invasive Bladder Cancer
On December 16, the U.S. Food and Drug Administration (FDA) approved nadofaragene firadenovec-vncg (Adstiladrin), a nonreplicating adenoviral vector–based gene therapy indicated for the treatment of adult patients with high-risk bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive...
FDA Approves Updated Drug Labeling for Capecitabine Tablets Under Project Renewal
On December 14, the U.S. Food and Drug Administration (FDA) approved updated labeling for capecitabine tablets (Xeloda) under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically...
Zanubrutinib Found Superior to Ibrutinib for CLL and SLL
Zanubrutinib showed superior efficacy to ibrutinib—with fewer side effects—in the first head-to-head comparison between the Bruton’s tyrosine kinase (BTK) inhibitors among patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), according to data presented by Jennifer...
Blinatumomab Further Improves Survival Among Patients With B-Lineage ALL and a Good Prognosis
The bispecific T-cell engager molecule blinatumomab was found to improve overall survival for patients with no measurable residual disease (MRD) after initial treatment for B-lineage acute lymphoblastic leukemia (ALL), according to the phase III ECOG-ACRIN E1910 trial presented by Litzow et al at...
Three-Drug Combination Therapy May Be Effective in Patients With High-Risk CLL
A three-drug combination that showed success at sending patients with chronic lymphocytic leukemia (CLL) into deep remissions in a clinical trial may be effective at treating patients with high-risk types of the disease, according to new findings presented by Ryan et al at the 2022 American Society ...
FDA Grants Accelerated Approval to Adagrasib for KRAS G12C–Mutated NSCLC
On December 12, the U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati), a RAS GTPase family inhibitor, for adult patients with KRAS G12C–mutated, locally advanced or metastatic non–small cell lung cancer (NSCLC), as determined by an FDA-approved test, who...
Jiye Liu, PhD, on Multiple Myeloma: Genome-Wide CRISPR-Cas9 Screening Identifies KDM6A as a Modulator of Daratumumab Sensitivity
Jiye Liu, PhD, of Dana-Farber Cancer Institute, discusses study findings that demonstrate KDM6A regulates CD38 and CD48 expression in multiple myeloma. Dr. Liu’s team validated combination treatment with an FDA-approved EZH2 inhibitor plus daratumumab, which can overcome daratumumab resistance in...
FDA Grants Approval to Atezolizumab in Treatment of Alveolar Soft-Part Sarcoma
On December 9, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft-part sarcoma (ASPS). Study ML39345 Efficacy was evaluated in Study ML39345...
How Low-Dose Oral Minoxidil Is Providing Hope for Patients With Later-Stage Alopecia
Chemotherapy-induced hair loss affects 65% of patients with cancer,1 and the psychosocial impact on these patients can be profound; it may include anxiety, depression, a negative body image, lowered self-esteem, and a reduced sense of well-being.2 In some instances, the fear of hair loss from...
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,...
Neoadjuvant T-DXd Shows Clinical Activity in Patients With HER2-Low Breast Cancer
Patients with localized, hormone receptor (HR)-positive, HER2-low breast cancer treated with fam-trastuzumab deruxtecan-nxki (T-DXd) in the neoadjuvant setting had an overall response rate of 75% without combining the agent with anastrozole and 63% in combination with anastrozole, according to...
Lu-177 Vipivotide Tetraxetan Shows Benefit in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
On December 5, Novartis announced the pivotal phase III PSMAfore study of lutetium (Lu-177) vipivotide tetraxetan, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint. The therapy demonstrated a statistically significant and clinically meaningful...
FDA Approvals: November 2022
On this episode, we’re reviewing U.S. Food and Drug Administration (FDA) approvals in oncology and hematology that occurred during the month of November.
FDA Approves Olutasidenib for Relapsed or Refractory AML With a Susceptible IDH1 Mutation
On December 1, the U.S. Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. The FDA also approved the Abbott RealTime IDH1...
FDA Grants Accelerated Approval to Teclistamab-cqyv for Resistant Myeloma
On October 25, 2022, 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 adults with relapsed or refractory multiple myeloma who have received at least four...
ASCO Publishes Rapid Guideline Update on PARP Inhibitors in Ovarian Cancer
An ASCO guideline rapid update is revising guidance for the use of poly (ADP-ribose) polymerase (PARP) inhibitor therapy for the management of ovarian cancer to include updated considerations for the use of several different PARP inhibitor therapies based on recent phase III clinical trial data.1...
FDA 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...
