
Swissmedic has accepted for review a marketing authorization application seeking the approval of Piflufolastat (18F) for prostate cancer.

Associate Editor, OncLive
Ashling Wahner joined MJH Life Sciences in 2022. She produces OncLive's podcast, OncLive On Air, and helps ensure timely publication of news content and announcements from the FDA approval pipeline. She also attends conferences live and virtually to conduct video interviews and produce written coverage. Email: [email protected]

Swissmedic has accepted for review a marketing authorization application seeking the approval of Piflufolastat (18F) for prostate cancer.

Jan Joseph Melenhorst, PhD, emphasizes how research investigating chronic lymphocytic leukemia biology may result in more targeted CAR T-cell products.

A biologics license application for linvoseltamab in relapsed/refractory multiple myeloma has been accepted for priority review by the FDA.

IMM-1-104 received FDA fast track designation for use in patients with pancreatic ductal adenocarcinoma who have progressed on 1 line of treatment.

Vorasidenib has been granted regulatory submission acceptance by the FDA and EMA for IDH-mutant diffuse glioma.

Zev A. Wainberg, MD, discusses the FDA approval of NALIRIFOX in patients with metastatic pancreatic adenocarcinoma and key data from the NAPOLI 3 trial.

Catherine C. Coombs, MD, spotlights the use of bispecific antibodies in diffuse large B-cell lymphoma and pirtobrutinib in mantle cell lymphoma.

Carrie L. Kitko, MD, and Sagar S. Patel, MD, discuss recent treatment developments and ongoing unmet needs in the graft-vs-host treatment paradigm.

R. Lor Randall, MD, discusses the adequacy of active surveillance for select patients with diffuse-type tenosynovial giant cell tumor.

Catherine C. Coombs, MD, discusses future directions for BTK inhibitors in chronic lymphocytic leukemia and combination therapies in myelofibrosis.

A new drug application for Dasynoc, a protein kinase inhibitor product candidate for patients with chronic myeloid leukemia, has been accepted by the FDA.

Michael R. Bishop, MD, discusses the rationale for and key findings from the FELIX trial of obe-cel in B-cell acute lymphoblastic leukemia.

AlphaMedix has received breakthrough therapy designation from the FDA for use in select patients with gastroenteropancreatic neuroendocrine tumors.

Radiographic and clinical progression-free survival may be surrogates for overall survival in hormone-sensitive prostate cancer clinical trials.

Hyperthermic intraperitoneal chemotherapy plus interval cytoreductive surgery improved progression-free survival in stage III epithelial ovarian cancer.

Balazs Halmos, MD, discusses the FLAURA2 and MARIPOSA trials of EGFR TKIs plus chemotherapy in EGFR-mutated non–small cell lung cancer.

Selinexor is under investigation as monotherapy and in combination with the JAK inhibitor ruxolitinib in patients with JAK inhibitor–naive myelofibrosis.

Rona Yaeger, MD, discusses a study of second-line sotorasib plus panitumumab in patients with KRAS G12C–mutated colorectal cancer.

Talha Badar, MBBS, MD, discusses the FDA approval of ivosidenib for patients with myelodysplastic syndrome and the future management of this disease.

The FDA has granted priority review to trastuzumab deruxtecan for patients with unresectable or metastatic HER2-positive advanced solid tumors.

Adjuvant pembrolizumab generated a disease-free survival benefit vs observation in patients with muscle-invasive and locally advanced urothelial carcinoma.

Ritu Salani, MD, provides an overview of the variety of sessions presented at the 2024 SGO Winter Meeting.

Susan Marie Lang, MD, discusses real-world data on the incidence of ocular toxicities in patients with ovarian cancer receiving mirvetuximab soravtansine.

William Pearse, MD, discusses how the FDA approval of pirtobrutinib for relapsed/refractory mantle cell lymphoma has advanced BTK inhibitor treatment.

Talha Badar, MBBS, MD, discusses myelodysplastic syndrome risk stratification and the FDA approval of luspatercept for patients with this disease.

William Pearse, MD, discusses the roles of acalabrutinib and zanubrutinib in mantle cell lymphoma, as well as the adverse effect profiles of each agent.

Guillermo Garcia-Manero, MD, spotlights the evolution of oral azacitidine- and decitabine-based regimens for MDS.

Neoadjuvant botensilimab/balstilimab led to robust responses in both patients with resectable mismatch repair–proficient and –deficient colorectal cancer.

Lutetium Lu 177 dotatate plus octreotide significantly improved PFS vs high-dose octreotide in patients with gastroenteropancreatic neuroendocrine tumors.

Ashley Sumrall, MD, FACP, discusses ongoing research with the DRD2 dopamine receptor–targeted agent ONC201 in patients with H3K27M-mutated glioma.