Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
The FDA has granted fast track designation to tulmimetostat for use as a potential therapeutic option in patients with advanced, recurrent, or metastatic endometrial cancer harboring ARID1A mutations and whose disease had progressed on at least 1 prior line of therapy.
The European Medicines Agency has validated its Type II variation for enzalutamide as an option in patients with nonmetastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence who are not suitable for salvage radiotherapy.
The addition of durvalumab to chemotherapy prior to surgery, followed by adjuvant durvalumab, did not provide a clear clinical benefit in patients with early-stage non–small cell lung cancer harboring an EGFR mutation, according to data from the phase 3 AEGEAN trial.
Treatment with iruplinalkib significantly improved progression-free survival and produced a higher objective response rate compared with crizotinib in patients with ALK TKI–naïve, locally advanced and metastatic ALK-positive non–small cell lung cancer, according to data from a prespecified interim analysis of the phase 3 INSPIRE trial.
The addition of benmelstobart to anlotinib and etoposide plus carboplatin significantly improved progression-free survival and overall survival over placebo plus etoposide plus carboplatin when used in the first-line treatment of patients with extensive-stage small cell lung cancer.
Subcutaneous epcoritamab produced deep and durable complete remissions in patients with relapsed or refractory large B-cell lymphoma, with complete responders having favorable long-term outcomes, according to updated data from the phase 1/2 EPCORE NHL-1 trial.
Early cytogenetic and molecular responses achieved with ponatinib was significantly linked with better long-term progression-free survival and overall survival in patients with highly resistant, pretreated chronic-phase chronic myeloid leukemia.
The FDA has accepted a biologics license application seeking the approval of crovalimab for use in patients with paroxysmal nocturnal hemoglobinuria.
The National Medical Products Administration in China has approved acalabrutinib for use in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received at least 1 therapy.
The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.
The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.
Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.
The FDA has approved luspatercept-aamt (Reblozyl) for the treatment of anemia without prior erythropoiesis stimulating agent (ESA) use in adult patients with very low– to intermediate-risk myelodysplastic syndrome (MDS) who may require regular red blood cell (RBC) transfusions.
The European Medicines Agency has granted orphan drug designation to mitazalimab for use in patients with pancreatic cancer.
The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.
A supplemental biologics license application seeking the expanded approval of amivantamab-vmjw in combination with carboplatin plus pemetrexed for use in the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations has been submitted to the FDA.
Sovleplenib provided a statistically significant and clinically meaningful increase in durable response rate over placebo in adult patients with primary immune thrombocytopenia in China.
An independent data monitoring committee has recommended that the phase 3 REGAL trial evaluating galinpepimut-S in patients with acute myeloid leukemia should continue without modifications.
The National Medical Products Administration of China has approved sunvozertinib for use in adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy.
The FDA has granted orphan drug designation to NXC-201 for use as a potential therapeutic option in patients with multiple myeloma.
Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.
The FDA has accepted and granted priority review to a supplemental new drug application seeking the approval of enzalutamide in patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence.
The European Commission has approved single-agent nivolumab for use in the adjuvant treatment of adult and adolescent patients aged 12 years or older who have stage IIB or IIC melanoma and who have undergone complete resection.
Selpercatinib demonstrated a statistically significant improvement in progression-free survival vs physician’s choice of cabozantinib or vandetanib in patients with advanced or metastatic RET-mutant medullary thyroid cancer, meeting the primary end point of the phase 3 LIBRETTO-531 trial.
Furmonertinib had efficacy and an acceptable toxicity profile when utilized as adjuvant treatment in EGFR-mutated, stage IA2-IIIA non–small cell lung cancer with high-risk pathological factors who have undergone radical surgery
The combination of ociperlimab, tislelizumab, and chemotherapy elicited responses in patients with stage IV gastric or gastroesophageal junction cancer, irrespective of PD-L1 expression.
Berubicin was found to have acceptable tolerability when administered as second-line treatment in patients with recurrent or refractory glioblastoma multiforme.
The FDA has approved HEPZATO KIT (melphalan/Hepatic Delivery System) for use in the treatment of select patients with unresectable hepatic-dominant metastatic uveal melanoma.
The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.
The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
