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Showing 901 - 950Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression in Extensive-Stage Small Cell Lung Cancer
On February 12, 2021, the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor trilaciclib was approved for use to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide–containing regimen or topotecan-containing regimen for...
Pralsetinib in Advanced RET Fusion–Positive NSCLC: ARROW Trial
As reported in The Lancet Oncology by Justin F. Gainor, MD, and colleagues, an interim analysis of the phase I/II ARROW trial has shown that the oral RET inhibitor pralsetinib produced high response rates in previously treated and treatment-naive patients with advanced RET fusion–positive non–small ...
Expert Point of View: Mansoor Raza Mirza, MD
The invited discussant of EMPOWER-Cervical 1 was Mansoor Raza Mirza, MD, Chief Oncologist at Copenhagen University Hospital and Chairman of the European Network of Gynaecological Oncology Trials group (ENGOT). Dr. Mirza called the findings “amazing” and predicted they will “usher in a new era” in...
Immunotherapy With Cemiplimab-rwlc Yields Survival Benefit in Advanced Cervical Cancer
The PD-L1 inhibitor cemiplimab-rwlc has become the first immunotherapy to yield a statistically significant and clinically meaningful survival benefit in recurrent or metastatic cervical cancer progressing after first-line platinum-containing chemotherapy. Patients were enrolled irrespective of...
FDA Approves New Pediatric Indication for Technetium Tc 99m Tilmanocept Injection
The Lymphoseek (technetium Tc 99m tilmanocept) injection—a radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies—has been approved for pediatric use by the U.S. Food and Drug Administration (FDA). "This new indication opens the door...
Dual Immune Checkpoint Blockade With Nivolumab and Ipilimumab for Treatment of Malignant Pleural Mesothelioma
In recent years, immune checkpoint inhibitors in the treatment of mesothelioma have been a keen area of investigation for this immunogenic solid tumor. With recent publications, principally findings from CheckMate 743 by Baas et al1 (reviewed in this issue of The ASCO Post), combination immune...
Is High Tumor Mutational Burden Predictive of Immune Checkpoint Blockade Efficacy Across All Cancer Types?
In a letter recently published in The New England Journal of Medicine and reviewed in this issue of The ASCO Post, Rousseau and colleagues reported data on the spectrum of benefit from immune checkpoint blockade in hypermutated tumors.1 Indeed, the U.S. Food and Drug Administration (FDA) recently...
Is Tumor Mutational Burden Predictive of Survival Outcomes in Solid Tumors Treated With Immune Checkpoint Inhibitors?
In a letter to the editor in The New England Journal of Medicine, Benoit Rousseau, MD, PhD, and Michael B. Foote, MD, of Memorial Sloan Kettering Cancer Center (MSK), and colleagues presented evidence that a high tumor mutational burden (TMB) threshold of 10 alone may not be sufficient to predict...
Atezolizumab Reduces Risk of Disease Progression in Patients With PD-L1–Expressing Early-Stage NSCLC
Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...
100th Episode: Reports From the 2021 ASCO Annual Meeting in Breast, Prostate, and Lung Cancers
This week marks our 100th episode of the podcast! We launched at the start of the 2019 ASCO Annual Meeting, and this week, we’re reporting major findings from the 2021 Annual Meeting, including adjuvant therapy for patients with BRCA-mutated breast cancer, LuPSMA for metastatic prostate cancer, and ...
Toripalimab Plus Gemcitabine/Cisplatin Extends Progression-Free Survival in Recurrent or Metastatic Nasopharyngeal Carcinoma: JUPITER-02
According to the results from the phase III JUPITER-02 study, the addition of toripalimab, a humanized IgG4K anti–PD-1 monoclonal antibody, to standard gemcitabine/cisplatin chemotherapy as first-line treatment for patients with advanced nasopharyngeal carcinoma provided superior progression-free...
Community-Based Engagement Initiative Improves Accrual of Black Participants in Clinical Trials
A 5-year community outreach and engagement effort by the Abramson Cancer Center at the University of Pennsylvania to increase enrollment of Black patients into cancer clinical trials more than doubled the percentage of participants, improving access and treatment for a group of patients with...
A Junior High School Teacher Sparks a Love for Science
Peter Marks, MD, PhD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER), was born in Brooklyn, New York, near Sheepshead Bay—an area named for the Sheepshead, a fish that can no longer be found in the waters that frame the neighborhood....
A Junior High School Teacher Sparks a Love for Science
Peter Marks, MD, PhD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER), was born in Brooklyn, New York, near Sheepshead Bay—an area named for the Sheepshead, a fish that can no longer be found in the waters that frame the neighborhood....
New FDA-Approved Oncology Drugs and Label Updates Between May 8, 2020, and May 8, 2021
Over the past year (May 2020–May 2021), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below. PEMBROLIZUMAB (KEYTRUDA) in...
FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma With an FGFR2 Fusion or Rearrangement
On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor infigratinib (Truseltiq) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or ...
FDA Approves Sotorasib for KRAS G12C–Mutated NSCLC
On May 28, the U.S. Food and Drug Administration (FDA) approved sotorasib (Lumakras) as the first treatment for adult patients with non–small cell lung cancer (NSCLC) whose tumors have a KRAS G12C genetic mutation and who have received at least one prior systemic therapy. This is the first approved ...
Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphoma
On February 5, 2021, lisocabtagene maraleucel was approved 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 otherwise specified (including DLBCL arising from...
FDA Approves Piflufolastat F-18 Injection, a PSMA PET Imaging Agent, for the Detection of Metastatic or Recurrent Prostate Cancer
On May 27, the U.S. Food and Drug Administration (FDA) approved piflufolastat F-18 injection (Pylarify), an F-18–labeled prostate-specific membrane antigen (PSMA)-targeted positron-emission tomography (PET) imaging agent, to identify suspected metastasis or recurrence of prostate cancer. This is...
Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma
On March 26, 2021, idecabtagene vicleucel was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.1,2 Idecabtagene vicleucel is...
Fam-trastuzumab Deruxtecan-nxki for Trastuzumab-Pretreated Advanced HER2-Positive Gastric Adenocarcinoma
On January 15, 2021, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki was approved for treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.1,2 Supporting Efficacy Data...
EMPOWER-Lung 1 Trial: New Options, No New Answers
The EMPOWER-Lung 1 trial, recently reported in The Lancet and reviewed in this issue of The ASCO Post, showed an improvement in progression-free and overall survival with cemiplimab-rwlc in patients with advanced non–small cell lung cancer (NSCLC) and high PD-L1 expression (tumor proportion score...
First-Line Cemiplimab-rwlc Improves Outcomes vs Platinum-Doublet Chemotherapy in Advanced NSCLC With PD-L1 Expression ≥ 50%
As reported in The Lancet by Ahmet Sezer, MD, of Başkent University, Adana, Turkey, and colleagues, 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...
FDA ODAC Meeting Focuses on ‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies
In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...
Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
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 February 26, 2021, the peptide-conjugated alkylating...
Douglas R. Lowy, MD, FAACR, Honored With 2021 AACR–Margaret Foti Award
The American Association for Cancer Research (AACR) presented Douglas R. Lowy, MD, FAACR, with the 2021 AACR–Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research during the virtual AACR Annual Meeting 2021. Dr. Lowy is Chief of the Laboratory of Cellular Oncology,...
FDA Grants Accelerated Approval to Amivantamab-vmjw for Metastatic EGFR Exon 20 Insertion–Mutated NSCLC
On May 21, the U.S. Food and Drug Administration (FDA) granted accelerated approval to amivantamab-vmjw (Rybrevant), a bispecific antibody directed against epidermal growth factor and MET receptors, for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) and...
FDA Pipeline: Applications Accepted for Marginal Zone Lymphoma and Lung Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to zanubrutinib in pretreated patients with marginal zone lymphoma, and accepted a biologics license application for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line...
FDA Approves Nivolumab for Resected Esophageal or Gastroesophageal Junction Cancer
On May 20, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. CheckMate 577 Efficacy was evaluated in CheckMate ...
FDA Pipeline: Priority Reviews in Kidney and Endometrial Cancers, Cholangiocarcinoma
Recently, the U.S. Food and Drug Administration (FDA) has granted Priority Review to the combination of pembrolizumab and lenvatinib for the treatment of both advanced renal cell carcinoma (RCC) and endometrial carcinoma. The FDA also granted Priority Review to ivosidenib for the treatment of...
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents
On May 10, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents aged 12 through 15. The FDA...
Margetuximab-cmkb: A Novel Agent Overshadowed by an Abundance of Options in HER2-Positive Breast Cancer
It is incredible to reflect upon the scientific advances in the treatment of HER2-positive breast cancer over the past 23 years. Once considered the worst subtype of breast cancer, HER2-positive disease is now associated with the best long-term outcomes in this age of targeted treatments. With a...
Cemiplimab-rwlc for First-Line Treatment of NSCLC With High PD-L1 Expression
On February 22, 2021, cemiplimab-rwlc was approved for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC; locally advanced who are not candidates for surgical resection or definitive chemoradiation therapy or metastatic) whose tumors have high PD-L1 expression (tumor...
FDA Approves Nivolumab in Combination With Chemotherapy for Metastatic Gastric Cancer and Esophageal Adenocarcinoma
On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. CheckMate 649 The...
Cannabis
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 article, Nirupa Raghunathan, MD, and Jyothirmai Gubili, MS, focus on the increasing use...
Early Triple-Negative Breast Cancer: Are Checkpoint Inhibitors Ready for Neoadjuvant or Adjuvant Use?
Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at PER’s Miami Breast Cancer Conference, held virtually this year, by Adam M....
FDA Grants Accelerated Approval to Pembrolizumab Combination for HER2-Positive Gastric Cancer
On May 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic...
Expanding Role of Liquid Biopsies in Cancer Detection and Therapeutics: Now and in the Near Future
“It is possible that within the next several years, perhaps 75% of cancers can be detected by screening,” Bert Vogelstein, MD, PhD, projected at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 “I anticipate that perhaps 50% of cancers can be detected...
FDA Pipeline: Priority Reviews of Treatments for Bladder and Lung Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to treatments for surgically resected, high-risk, muscle-invasive urothelial carcinoma and epidermal growth factor receptor exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC)....
More From the FDA ODAC: Votes on Agents for Pretreated Hepatocellular Carcinoma and Gastric Cancer
More news has emerged from this week’s meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC). The group voted 8 to 0 in favor of continuing the accelerated approval for pembrolizumab in sorafenib-pretreated patients with hepatocellular carcinoma; 6 to 2...
FDA ODAC Votes in Favor of Retaining Accelerated Approval for Bladder Cancer Treatments
Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...
Updated Information on Sotorasib Dose-Comparison Study
Amgen has announced that it agreed with the U.S. Food and Drug Administration's proposed postmarketing requirement to conduct, as part of the ongoing development program, a multicenter randomized clinical trial to compare the safety and efficacy of sotorasib at 960 mg once daily vs a lower daily...
New Research Finds Few Young Adult Men Have Received the HPV Vaccine
Using data from the 2010–2018 National Health Interview Surveys, Chen et al found that just 16% of men who were 18 to 21 years old had received at least one dose of the human papillomavirus (HPV) vaccine at any age. In comparison, 42% of women in the same age bracket had gotten at least one shot of ...
FDA ODAC Votes in Favor of Maintaining Accelerated Approval of Atezolizumab/Nab-paclitaxel for PD-L1–Positive, Metastatic Triple-Negative Breast Cancer
Roche announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted seven to two in favor of maintaining accelerated approval of atezolizumab in combination with chemotherapy (nanoparticle albumin-bound paclitaxel, or nab-paclitaxel) for the treatment of ...
FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for Large B-Cell Lymphoma
On April 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, ...
Umbralisib for Previously Treated Relapsed or Refractory Marginal Zone Lymphoma and Follicular Lymphoma
On February 5, 2021, umbralisib was granted accelerated approval for the following indications: adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti–CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have...
Ethical Considerations Before Launching a Clinical Cancer Trial
Randomized clinical trials are highly regulated initiatives that must comply with multiple requirements while maintaining high epistemic standards, a balance that becomes increasingly difficult as the research questions surrounding immunotherapy and targeted agents become more complex. To shed...
A Physician-Scientist’s Mother, Who Nursed Those With Chronic Diseases, Fueled His Passion for Biomedical Research
For this installment of the Living a Full Life series, guest editor Jame Abraham, MD, spoke with Griffin P. Rodgers, MD, MACP, Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH). Dr. Rodgers, a physician-scientist,...
Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for...
‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies to Be Discussed at FDA Oncologic Drugs Advisory Committee Meeting
In a Perspective article in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCD), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie,...
