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Showing 501 - 550FDA Expands Early Breast Cancer Indication for Abemaciclib Plus Endocrine Therapy
On March 3, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) plus endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive early breast cancer at high risk of...
Grateful to Be Alive
Although there is no history of cancer in my family, I guess it isn’t surprising that I would develop an aggressive form of melanoma on my scalp after years of ultraviolet radiation from sun exposure. Still, getting the diagnosis was devastating. I first noticed a small lump on the top of my head ...
Yale Study Indicates Older Patients Are Excluded From Progress Against Lung Cancer
The widespread use of immune checkpoint inhibitors has led to significant benefits in younger patients with advanced lung cancer; however, older patients have not experienced similar survival benefits, according to research from Yale Cancer Center. The study was published in JAMA Oncology.1 “There ...
TALAPRO-2: Talazoparib Plus Enzalutamide Improves Progression-Free Survival in Metastatic Castration-Resistant Prostate Cancer
The TALAPRO-2 phase III clinical trial found that combining the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib with the androgen receptor inhibitor enzalutamide resulted in significantly better progression-free survival vs the current standard of care for patients with metastatic...
MAGNOLIA Trial: Zanubrutinib Yields High Response Rates With Low Rate of Cardiac Events in Marginal Zone Lymphoma
Zanubrutinib—a next-generation Bruton’s tyrosine kinase (BTK) inhibitor—achieved high response rates and durable disease control with a low incidence of cardiac effects in patients with relapsed or refractory marginal zone lymphoma, according to updated findings from the final analysis of the phase ...
Is Zanubrutinib Poised to Become a New Standard of Care in Relapsed or Refractory CLL and SLL?
The next-generation Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib demonstrated superior progression-free survival compared with ibrutinib, with an improved cardiac safety profile, in the first head-to-head comparison between these two BTK inhibitors in relapsed or refractory chronic...
Blinatumomab Improves Survival in MRD-Negative, B-Cell ALL
The standard of care could be changing for adults with newly diagnosed BCR-ABL–negative B-lineage acute lymphoblastic leukemia (ALL) who achieve measurable residual disease (MRD) negativity after induction chemotherapy. In the phase III E1910 trial by the ECOG-ACRIN Cancer Research Group, an...
Highlights From the 2022 ASH Annual Meeting and Exposition
The 2022 American Society of Hematology (ASH) Annual Meeting and Exposition took place in the vibrant city of New Orleans. The meeting brought together tens of thousands of participants from across the world to present and discuss the results of studies that ranged from hypothesis-generating to...
Recent FDA Approvals for Patients With Breast Cancer
On this episode, we’re reviewing two recent U.S. Food and Drug Administration (FDA) approvals for patients with breast cancer: the February 3 approval of sacituzumab govitecan-hziy, and the January 27 approval of elacestrant.
FDA Grants Regular Approval to Dostarlimab-gxly for dMMR Endometrial Cancer
On February 9, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient (dMMR), recurrent or advanced endometrial cancer, as determined by an FDA-approved test, whose disease has progressed on or...
Influence of the ‘Mark Cuban Effect’ on Cancer Drug Prices in the United States: Focus on CML
The advent of the BCR::ABL1 tyrosine kinase inhibitors for the treatment of Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) was a therapeutic miracle that changed the management paradigm of CML. The first of them, imatinib, was developed in the late 1990s.1,2 Within a few...
Carl H. June, MD, Honored With 2023 AACR Award for Lifetime Achievement in Cancer Research
The American Association for Cancer Research (AACR) will award Carl H. June, MD, with the 2023 AACR Award for Lifetime Achievement in Cancer Research during the AACR Annual Meeting 2023, taking place from April 14 to 19 in Orlando, Florida. Dr. June is the Richard W. Vague Professor in...
FDA Approves Sacituzumab Govitecan-hziy for Pretreated Patients With HR-Positive, HER2-Negative Breast Cancer
On February 3, the U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable, locally advanced or metastatic, hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+ with a negative in situ...
Uptake of Immune Checkpoint Inhibitors and Survival Among Younger and Older Patients With Advanced NSCLC
In a U.S. cohort study reported in JAMA Oncology, Voruganti et al found that the uptake of immune checkpoint inhibitor therapy for patients with advanced non–small cell lung cancer (NSCLC) has been associated with “modest” improvements in overall survival, particularly among older patients. As...
FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
On January 27, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca) for patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BRUIN Efficacy was...
FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
On January 27, the U.S. Food and Drug Administration (FDA) approved elacestrant (Orserdu) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine...
FDA Approves Pembrolizumab as Adjuvant Treatment for NSCLC
On January 26, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage IB (T2a, ≥ 4 cm), II, or IIIA non–small cell lung cancer (NSCLC). KEYNOTE-091 Efficacy was evaluated in...
FDA Oncology Center of Excellence Seeks Applications for New Research Funding Opportunities
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, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD,...
Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With a Susceptible IDH1 Mutation
On December 1, 2022, the IDH1 inhibitor olutasidenib was approved for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Abbott...
MAGNOLIA Trial: Zanubrutinib Yields High Response Rates With Low Rate of Cardiac Events in Marginal Zone Lymphoma
Zanubrutinib—a next-generation Bruton’s tyrosine kinase (BTK) inhibitor—achieved high response rates and durable disease control with a low incidence of cardiac effects in patients with relapsed or refractory marginal zone lymphoma, according to updated findings from the final analysis of the phase ...
FDA Approves Zanubrutinib for CLL or SLL
On January 19, the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor zanubrutinib (Brukinsa) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). SEQUOIA Trial: Treatment-Naive Patients Efficacy in treatment-naive patients...
Is Zanubrutinib Poised to Become a New Standard of Care in Relapsed or Refractory CLL and SLL?
The next-generation Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib demonstrated superior progression-free survival compared with ibrutinib, with an improved cardiac safety profile, in the first head-to-head comparison between these two BTK inhibitors in relapsed or refractory chronic...
FDA Grants Accelerated Approval to Tucatinib Plus Trastuzumab for Advanced HER2-Positive Colorectal Cancer
On January 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor tucatinib (Tukysa) in combination with the monoclonal antibody trastuzumab for RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following...
Tremelimumab-actl in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
On October 21, 2022, tremelimu-mab-actl was approved by the U.S. Food and Drug Administration (FDA) for use in combination with durvalumab in the treatment of unresectable hepatocellular carcinoma.1 Supporting Efficacy Data Approval was based on a comparison of overall survival in the...
Blinatumomab Improves Survival in MRD-Negative, B-Cell ALL
The standard of care could be changing for adults with newly diagnosed BCR-ABL–negative B-lineage acute lymphoblastic leukemia (ALL) who achieve measurable residual disease (MRD) negativity after induction chemotherapy. In the phase III E1910 trial by the ECOG-ACRIN Cancer Research Group, an...
FoundationOne 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...
