Caroline Seymour

Editor, OncLive®
Caroline Seymour is your initial point of contact for the OncLive® podcast, OncLive On Air™. She joined the company in 2018 as an assistant editor, with expertise in video production and print/digital publication. Email: cseymour@onclive.com

Articles

FDA Grants Orphan Drug Designation to VCN-01 for Pancreatic Cancer

June 28th 2023

The FDA has granted an orphan drug designation to VCN-01, a systemic, selective, stroma-degrading oncolytic adenovirus for the treatment of patients with pancreatic cancer.

NKX101 Demonstrates Early Activity in Relapsed/Refractory AML

June 27th 2023

Treatment with NKX101 led to a best composite complete response rate of 67% in patients with relapsed/refractory acute myeloid leukemia, according to updated data from a dose-expansion cohort of an ongoing phase 1 trial.

FDA Approves Iopromide Injection for Contrast-Enhanced Mammography

June 26th 2023

The FDA has approved the first and only iodine-based contrast agent iopromide-300, -370 injection for intra-arterial and intravenous contrast-enhanced mammography.

FDA Grants Orphan Drug Designation to ERAS-801 for Malignant Glioma

June 23rd 2023

The FDA has granted an orphan drug designation to the orally bioavailable, reversible small molecule EGFR inhibitor ERAS-801 for the treatment of patients with malignant glioma, including glioblastoma.

NCCN Adds Epcoritamab to Clinical Practice Guidelines in Oncology for B-Cell Lymphomas

June 23rd 2023

Epcoritamab has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for B-cell Lymphomas in the third- or later-line setting for the treatment of patients with diffuse large B-cell lymphoma, including patients with disease progression after transplant or CAR T-cell therapy, and as a category 2A preferred regimen for patients with histologic transformation of indolent lymphoma to DLBCL with no intention to proceed to transplant, including patients with disease progression after transplant or CAR T-cell therapy.

Venetoclax Plus Obinutuzumab Demonstrates Durable Survival Benefit in Treatment-Naïve CLL

June 22nd 2023

Fixed-duration therapy with venetoclax plus obinutuzumab led to 60% reduction in the risk of progression or death compared with chlorambucil plus obinutuzumab, with benefit seen regardless of TP53 or IGHV mutation status, in previously untreated patients with chronic lymphocytic leukemia.

Zanubrutinib Plus Obinutuzumab and Venetoclax Induces High Undetectable MRD Rate in CLL/SLL

June 22nd 2023

Zanubrutinib plus obinutuzumab and venetoclax demonstrated lasting responses characterized by sustained progression-free survival and undetectable minimal residual disease in peripheral blood and bone marrow in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

FDA Places Clinical Hold on BCMA-Directed Modified CAR T-Cell Therapy in Multiple Myeloma

June 20th 2023

The FDA has placed a hold on the clinical program for the investigational new drug CART-ddBCMA for the treatment of patients with relapsed/refractory multiple myeloma.

Ibrutinib Plus Chemoimmunotherapy Fails to Improve PFS in Pretreated Follicular Lymphoma, MZL

June 19th 2023

The addition of ibrutinib to bendamustine plus rituximab or R-CHOP did not lead to a statistically significant improvement in progression-free survival vs either chemoimmunotherapy regimen alone in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma.

European Medicines Agency Validates MAA for Fruquintinib in Pretreated mCRC

June 16th 2023

The European Medicines Agency has validated and accepted a marketing authorization application for priority review for fruquintinib for the treatment of adult patients with pretreated metastatic colorectal cancer.

Pacritinib Provides Spleen, Symptom Reduction Regardless of Blood Counts, Association Between SVR and OS in Myelofibrosis

June 16th 2023

Treatment with the JAK2 inhibitor pacritinib demonstrated comparable improvements in spleen and symptom response regardless of baseline platelet counts and hemoglobin levels, according to findings from the pivotal phase 3 PERSIST-1 and PERSIST-2 trials.

Duvelisib Demonstrates Higher Activity in Angioimmunoblastic Peripheral T-Cell Lymphoma

June 15th 2023

Treatment with duvelisib led to a high response rate in patients with peripheral T-cell lymphoma, with activity favoring patients with PTCL not otherwise specified and angioimmunoblastic T-cell lymphoma.

FDA Approves New Drug Application for Oncology Injectable Pemrydi RTU

June 14th 2023

The FDA has approved a 505(b)(2) new drug application for Pemrydi RTU, the first and only ready-to-use presentation of pemetrexed or injection that does not require reconstitution, dilution, or refrigeration

FDA Set to Review Exagamglogene Autotemcel for Sickle Cell Disease, Transfusion-Dependent Beta Thalassemia

June 12th 2023

The FDA has granted priority and standard review designations to the biologics license applications for exagamglogene autotemcel for the treatment of patients with sickle cell disease and transfusion-dependent beta thalassemia, respectively, marking the first CRISPR gene editing filings to be accepted for review by the FDA.

FDA Grants Priority Review to Capivasertib Plus Fulvestrant in Advanced HR+ Breast Cancer

June 12th 2023

The FDA has accepted and granted priority review designation to the new drug application for the combination of capivasertib and fulvestrant for the treatment of patients with hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after endocrine-based therapy.

Rusfertide Offers Durable Hematocrit Control in Phlebotomy-Dependent Polycythemia Vera

June 11th 2023

Rusfertide demonstrated freedom from phlebotomy, sustained hematocrit control, and 12-week treatment completion in 69.2% vs 18.5% of patients with phlebotomy-dependent polycythemia vera who received placebo, meeting the primary end point of the phase 2 REVIVE trial.

Pelabresib Provides Clinical Benefit in Hydroxyurea-Refractory or Intolerant High-Risk Essential Thrombocythemia

June 9th 2023

Treatment with pelabresib monotherapy led to a 60% confirmed complete or partial hematologic response at any time without incurring grade 4 or 5 treatment-related adverse effects in patients with high-risk essential thrombocythemia refractory or intolerant to hydroxyurea.

Acalabrutinib and Zanubrutinib Produce Similar PFS in a Matching-Adjusted Indirect Comparison in R/R CLL

June 8th 2023

Acalabrutinib and zanubrutinib demonstrated similar investigator-assessed progression-free survival in patients with relapsed/refractory chronic lymphocytic leukemia.

Liso-Cel Leads to Rapid Responses, High Undetectable MRD Rates in Relapsed/Refractory CLL/SLL

June 6th 2023

Treatment with lisocabtagene maraleucel elicited encouraging responses regardless of prior progression on BTK inhibition or absence of clinical benefit with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, meeting the primary end point of the phase 1/2 TRANSCEND CLL 004 trial.

mRNA-4157 Plus Pembrolizumab Improves DMFS in High-Risk Melanoma

June 6th 2023

The combination of mRNA-4157 and pembrolizumab reduced the risk of developing distant metastasis or death by approximately 65% compared with pembrolizumab alone as adjuvant therapy in patients with resected melanoma at high risk of recurrence, according to findings from the phase 2 KEYNOTE-942 trial.