Ashling Wahner

The FDA has published a collection of complete response letters that were seeking the approval of drugs or biologic products between 2020 and 2024.

The combination of enzalutamide and leuprolide improved OS vs leuprolide alone in nmHSPC with high-risk biochemical recurrence at high risk for metastasis.

Kevin Kalinsky, MD, MS, FASCO, discusses the importance of optimizing endocrine-based therapies in hormone receptor–positive metastatic breast cancer.

Decitabine plus cedazuridine and venetoclax is under review for patients with newly diagnosed AML who are ineligible for intensive induction chemotherapy.

The phase 3 SUPRAME trial is comparing IMA203 vs investigator’s choice of therapy in patients with pretreated unresectable or metastatic cutaneous melanoma.

FF-10832—an investigational liposomal formulation of gemcitabine—has received orphan drug designation from the FDA for biliary tract cancer.

The combination of nogapendekin alfa inbakicept and BCG is now approved in the United Kingdom for the treatment of patients with NMIBC with CIS.

Panitumumab plus FOLFIRINOX or mFOLFOX6 did not elicit meaningful responses in previously untreated, liver-limited, RAS/BRAF wild-type unresectable mCRC.

The FDA has approved SIR-Spheres Y-90 resin microspheres for the treatment of patients with unresectable hepatocellular carcinoma.

Irpagratinib combined with atezolizumab was effective and safe in both treatment-naive and ICI-exposed advanced HCC with FGF19 overexpression.

The EMA’s CHMP has issued a positive opinion for the use of MRD-negative CR as an end point for regulatory clinical trials for patients with myeloma.

Read a recap of the episodes of OncLive On Air that debuted in June 2025.

Kohei Shitara, MD, discusses the investigation of domvanalimab plus zimberelimab and chemotherapy in patients with gastric/GEJ/esophageal cancers.

Gallium Ga-68 gozetotide injection is now indicated for use in PET imaging patient selection for radioligand therapy in the pre-taxane setting for mCRPC.

The NCCN Clinical Practice Guidelines in Oncology for NSCLC recommend taletrectinib for the treatment of patients with advanced ROS1-positive NSCLC.

Ahmad Tarhini, MD, PhD, discusses key findings from the EA6194 trial and how these data support the continued investigation of vidutolimod in melanoma.

Mazyar Shadman, MD, MPH, discusses key efficacy and safety findings from arm D of the SEQUOIA trial of first-line zanubrutinib plus venetoclax in CLL/SLL.

Hematologic oncology experts share the studies they were most excited to see presented at the 2025 EHA Congress.

Miguel Gonzalez-Velez, MD, discusses the clinical implications of several lung cancer trials that were presented at the 2025 ASCO Annual Meeting.

Venetoclax plus azacitidine did not yield an OS benefit vs placebo plus azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes.

Alicia Morgans, MD, MPH, discusses findings from a QOL analysis of the ARANOTE trial, which evaluated darolutamide plus ADT in patients with mHSPC.

The FDA granted priority review to the sNDA seeking the approval of the first-line maintenance combination of lurbinectedin and atezolizumab for ES-SCLC.

Daneng Li, MD, discusses the IL-27–targeted agent casdozokitug in hepatocellular carcinoma.

Vivek Patel, MD, discusses the growing body of data supporting the use of bispecific antibodies in patients with relapsed/refractory follicular lymphoma.

Frontline BNT327/PM8002 plus chemotherapy was effective and safe in patients with unresectable pleural and peritoneal mesothelioma.

Brentuximab vedotin plus ECADD chemotherapy has been approved in Europe for adult patients with newly diagnosed, stage IIB to IV Hodgkin lymphoma.

The FDA has approved darolutamide for the treatment of patients with metastatic castration-sensitive prostate cancer.

Ziftomenib monotherapy elicited clinically meaningful, MRD-negative responses, including CRs, in heavily pretreated, relapsed/refractory NPM1-mutant AML.

The European Medicines Agency's CHMP has recommended the use of denosumab biosimilars referencing Prolia and Xgeva in all reference product indications.

Lutetium Lu 177 vipivotide tetraxetan plus hormone therapy yielded rPFS and OS benefits vs hormone therapy alone in patients with PSMA-positive mHSPC.