The use of multigene sequencing as a therapeutic decision tool improved outcomes for patients with metastatic breast cancer when the genomic alterations identified were ranked in the I/II tiers of the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT), according to results from the SAFIR02-BREAST trial.
The investigational oral selective estrogen receptor degrader elacestrant significantly decreased the risk of death or disease progression and increased progression-free survival compared with standard-of-care endocrine therapy for postmenopausal patients with estrogen receptor (ER)-positive/HER2-negative metastatic breast cancers that progressed on prior endocrine and targeted therapies, according to results from the phase III EMERALD trial.
Among patients with hormone receptor-positive breast cancer treated with an aromatase inhibitor plus Ibrance (palbociclib), those who displayed a rising ESR1 mutation detected in their blood before disease progression doubled their median progression-free survival following a switch to Faslodex (fulvestrant) plus Ibrance, according to results from the phase III PADA-1 clinical trial.
Black women experienced higher rates of breast cancer-related lymphedema than white women, and Black race was the strongest predictor of lymphedema development, according to results presented at the San Antonio Breast Cancer Symposium.
Results from the registration-enabling EXPLORER and PATHFINDER trials of Ayvakit (avapritinib) highlighted its robust efficacy and safety datasets in advanced systemic mastocytosis.
FDA has approved Rituxan (rituximab) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).
FDA approved FoundationOne CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, including BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations.
FDA has approved Cytalux, a fluorescent imaging agent that binds to cancer cells and allows physicians to identify cancerous lesions during ovarian cancer surgery.
FDA has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer patients whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Rybrevant (amivantamab-vmjw), Janssen Biotech Inc.’s targeted therapy.
FDA has accepted for priority review the supplemental Biologics License Application for Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent beta thalassemia.
