June 25, 2024 (View All Issues)
FDA Approves Selpercatinib for RET Fusion–Positive Thyroid Cancer
On June 12, the U.S. Food and Drug Administration (FDA) granted traditional approval to selpercatinib (Retevmo) for adult and pediatric patients aged 2 years and older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and whose disease is radioactive...
FDA Grants Accelerated Approval to Repotrectinib for NTRK Fusion–Positive Solid Tumors
On June 13, the U.S. Food and Drug Administration (FDA) granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients aged 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or...
Study Documents Decline in Reimbursements for Breast Cancer Surgery From 2003 to 2023
Over the past 20 years, Medicare reimbursements for 10 breast cancer surgical procedures rose by 22%, but inflation rose three times as much—by 69%. Compared with the financial picture had rates kept pace with inflation, the result is an estimated aggregate loss of more than $100 million for breast ...
Adjuvant Use of Alectinib in ALK-Positive NSCLC
On April 18, 2024, the ALK inhibitor alectinib was approved by the U.S. Food and Drug Administration (FDA) for adjuvant treatment after tumor resection in patients with ALK-positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.1
Supporting Efficacy Data
Approval was...
Eflornithine for Adult and Pediatric Patients With High-Risk Neuroblastoma
On December 13, 2023, eflornithine (Iwilfin), an ornithine decarboxylase inhibitor, was approved for adult and pediatric patients with high-risk neuroblastoma with at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.1
This represents the first...
Pembrolizumab/Chemotherapy in First-Line Treatment of HER2-Negative Advanced Gastric or GEJ Adenocarcinoma
On November 16, 2023, pembrolizumab (Keytruda) was approved with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.1
Supporting Efficacy Data
...
Study Finds Fewer Than Half of Accelerated Approval Drugs Show Benefit in Overall Survival or Quality of Life Within 5 Years
In 1992, the U.S. Food and Drug Administration (FDA) instituted the Accelerated Approval regulations, which allow drugs that treat serious conditions, including cancer, and fill an unmet need to be approved early based on a surrogate endpoint.1 However, any drug approved under this pathway is still ...
Addition of Adjuvant Ribociclib to Nonsteroidal Aromatase Inhibitor Therapy Improves Survival in Early Breast Cancer
As reported in The New England Journal of Medicine by Dennis Slamon, MD, PhD, of the David Geffen School of Medicine at the University of California, Los Angeles, and colleagues, interim analysis of the phase III NATALEE trial has shown improved invasive disease–free survival with the addition of ...
Lu-177 Dotatate for Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors
On April 23, 2024, lutetium Lu-177 dotatate (Lutathera) was approved for pediatric patients 12 years and older with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.1 Lu-177 dotatate is a radiolabeled...
CSHL and Northwell Health Extend Strategic Affiliation
Leaders from two New York bioscience and health-care institutions came together at Carnegie Hall to acknowledge the signing of an update to their affiliation agreement initiated in 2015. The Cold Spring Harbor Laboratory (CSHL)-Northwell Health agreement ensures continued collaboration and support...
Be Prepared: A Patient Perspective
I’m not prepared. It could be a few months, a few years, maybe longer. I don’t know how bad the verdict will be, but whatever it is, I’m not prepared.
They always told us to be prepared. That was our motto. At age 7, I joined the Brownies, the beginning of 12 years of being molded by Girl Scout...
Oral SERDs Poised to Impact Treatment of Hormone Receptor–Positive Breast Cancer
Suppression of the estrogen receptor has proven to be an effective treatment for hormone receptor–positive breast cancer, but standard endocrine therapies have liabilities that are not limited to their pharmacokinetics or toxicity profiles, which allow for ligand-independent estrogen receptor...
Durvalumab Consolidation Therapy Extends Survival in Limited-Stage Small Cell Lung Cancer
Consolidation therapy with the PD-L1 antibody durvalumab after chemoradiotherapy extended survival in patients with limited-stage small cell lung cancer (SCLC) compared with standard-of-care chemoradiotherapy alone, according to the first planned interim analysis of the phase III ADRIATIC trial...
Accelerating Progress in Melanoma and Cancer Research
The Melanoma Research Alliance is on a mission to cure and prevent melanoma, a skin cancer that is diagnosed in more than 100,000 people each year and is expected to take the lives of more than 8,000 individuals in 2024.1 We invite stakeholders across all fields, including medicine, science, and...
Advanced Lung Cancer: Studies Explore Palliative Care Delivered by Telehealth and in a Stepped-Care Approach
Early palliative care can be integrated into the course of treatment for patients with advanced lung cancer via delivery by telehealth with outcomes similar to when palliative care is delivered via in-person visits, according to results of the REACH PC trial presented by Joseph Greer, PhD, of...
DREAMM-8: Belantamab Mafodotin-blmf Shows ‘Robust’ Benefit in Early Relapse of Myeloma
Recent phase III findings support the antibody-drug conjugate belantamab mafodotin-blmf as a treatment option for patients with multiple myeloma in early relapse. Belantamab mafodotin is an antibody-drug conjugate targeting B-cell maturation antigen (BCMA) expressed on multiple myeloma cells,...
Phase I Study in NHL: Use of ‘Armored’ CAR T Cells May Be Feasible After Standard CAR T-Cell Failure
A novel “armored” chimeric antigen receptor (CAR) T cell appears to be feasible for retreatment of patients with non-Hodgkin lymphoma (NHL) who fail to respond to standard CAR T-cell therapy, according to preliminary results of a phase I trial presented at the 2024 ASCO Annual Meeting.1 The unique...
AACR Cancer Disparities Progress Report 2024 Highlights Ongoing Health Inequities Experienced by Racial and Ethnic Minorities
Despite the extraordinary progress against cancer in the United States—illustrated by the continuing decline in the overall mortality rate, which fell by 33% between 1991 and 2020, and the increasing numbers of cancer survivors (over 18 million and climbing)—the burden of cancer remains
On April 23, 2024, tovorafenib (Ojemda) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for patients aged 6 months and older who have relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or BRAF V600 mutation.1 Tovorafenib is a...Tovorafenib in Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma
Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
On March 22, 2024, mirvetuximab soravtansine-gynx (Elahere) was granted regular approval for adult patients with folate receptor–alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment...
Retroperitoneal Lymphadenectomy: Can It Be Safely Omitted for Some Patients With Advanced Ovarian Cancer?
Adding retroperitoneal lymphadenectomy to cytoreductive surgery during primary debulking surgery or interval cytoreductive surgery after neoadjuvant chemotherapy failed to improve progression-free or overall survival in patients with advanced ovarian cancer who have no suspicious nodes, according...
Long-Term Study Finds Most Breast Cancer Survivors Were Able to Preserve Fertility and Achieve Pregnancy After Diagnosis
Research examining fertility and attempts at pregnancy among young women after a breast cancer diagnosis has been hampered by short-term follow-up and a lack of prospective assessment of pregnancy attempts. However, a long-term study investigating fertility outcomes among young women who reported...
ASCO Issues New Guidance on Cannabis and Cannabinoid Use in Adults With Cancer
Many Americans, including patients with cancer, use cannabis and cannabinoids. In response to this reality, ASCO has issued a guideline for clinicians, adults with cancer, caregivers, and researchers on their medical use.1 The recommendations cover all cancer types and address products ranging from ...
ASCO Sets Six Guiding Principles for AI in Oncology
ASCO has released “Principles for the Responsible Use of Artificial Intelligence in Oncology,” to guide the Society’s consideration of all aspects of artificial intelligence (AI). With this manuscript, ASCO joins colleagues across medicine in offering principles that should be applied in...
Estrogen Alone Increased Ovarian Cancer Incidence and Mortality, Combination Hormone Therapy Did Not
In 2002, the federally funded Women’s Health Initiative (WHI),1 a randomized, placebo-controlled clinical trial investigating menopausal hormone therapy for healthy menopausal women, was abruptly halted when it was determined that taking estrogen and progestin hormones after menopause increased the ...
