FDA Approves Ensartinib in ALK-Positive NSCLC
Dec 18, 2024 · The FDA has approved ensartinib for the first-line treatment of patients with ALK-positive locally advanced or metastatic NSCLC who have not previously received an ALK-inhibitor. 1. Findings from the phase 3, randomized eXalt3 trial published in JAMA Oncology support this regulatory decision. The trial’s primary end point of progression-free survival (PFS) was met with ensartinib leading to ...
GLP-1 Agonists Poised to Impact Breast Cancer Care
Sep 25, 2024 · Recent trends have brought GLP-1 receptor agonists, including semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), to front of mind when discussing general weight loss. At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, multiple presentations focused on the weight loss aspect of GLP-1 agonists for patients with breast cancer.
Perioperative Pembrolizumab Betters Survival in Stage III/IV Head …
Oct 8, 2024 · Perioperative pembrolizumab (Keytruda) led to improved event-free survival (EFS) in patients with stage III or IVA, resected head and neck squamous cell carcinoma (HNSCC), meeting the primary end point of the phase 3 KEYNOTE-689 study (NCT03765918). 1 “These results are substantial, as KEYNOTE-689 marks the first positive trial in 2 decades for patients with resected, locally advanced head ...
Palbociclib Combo Shows Benefit to PFS in HR+, HER2+ Breast …
Dec 12, 2024 · A statistically significant and clinically meaningful median progression-free survival (PFS) improvement was demonstrated with palbociclib (Ibrance) plus standard-of-care therapy in patients with hormone receptor–positive, HER2-positive metastatic breast cancer as first-line maintenance therapy. 1 “Our results really reinforce the …
CAPOX Regimen Appears Noninferior to FOLFOX in Colorectal …
Oct 8, 2023 · The treatment landscape for patients with resected stage III colon cancer has undergone a significant change, following publication of an International Development and Education Award (IDEA) presentation abstract in the August 2023 Journal of the National Comprehensive Cancer Network. 1 Investigators observed an increasing trend in the use of 3-month adjuvant therapy with CAPOX (capecitabine ...
Promising Advances in Hematology: Key Findings From ASH 2024
Dec 17, 2024 · At the 2024 American Society of Hematology Annual Meeting & Exposition (ASH), a variety of promising therapies for the treatment of hematologic malignancies demonstrated significant efficacy and safety in real-world and clinical trial settings.. Here are some of the highlights from this year's meeting. Real-World Data Supports Efficacy and Safety of Liso-cel in Second-Line LBCL Treatment
Tamoxifen Cuts 15-Year Recurrence in DCIS Without Radiation …
Dec 13, 2024 · Findings from an ancillary analysis of the phase 3 NRG/RTOG 9804 (NCT00003857) and ECOG-ACRIN E5194 (NCT00002934) trials, revealed that tamoxifen (Soltamox) significantly reduced 15-year ipsilateral breast recurrence (IBR) in patients with “good risk” ductal carcinoma in situ (DCIS) who were treated without radiation therapy.
FDA Approves New Dosage of Trastuzumab Biosimilar for HER2 ...
Sep 19, 2024 · The FDA has approved the 420-mg strength of the trastuzumab (Herceptin) biosimilar trastuzumab-strf (Hercessi; formerly HLX02). The agent is approved to treat HER2-overexpressing cancers.
September 2024 FDA Roundup: Key Decisions Drive Oncology …
Oct 2, 2024 · FDA Grants Fast Track Designation to ICT01 Plus Azacitidine and Venetoclax in AML. ICT01, a humanized anti-BTN3A monoclonal antibody, plus azacitidine and venetoclax (Venclexta) earned fast track designation for the treatment of acute myeloid leukemia in patients 75 or older or those who have comorbidities that preclude standard induction chemotherapy on …
Frontline Approaches in CML Headline 2025 Conference
Dec 18, 2024 · FRONTLINE TYROSINE KINASE inhibitor (TKI) therapy in chronic myelogenous leukemia (CML) has been well established, with 4 TKIs currently available: imatinib (Gleevec), dasatinib (Sprycel), bosutinib (Bosulif), and nilotinib (Tasigna). Current guidelines promote all 4 agents as viable options for the management of chronic phase (CP) CML. 1 Despite these agents’ overall success among patients ...