All Oncology News

The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.

Duvelisib Plus Venetoclax Is Active in Relapsed/Refractory CLL and Richter Syndrome

January 9th 2025

Duvelisib plus venetoclax was active in relapsed/refractory CLL and Richter syndrome with high-risk, TP53-aberrant disease after BTK inhibition.

Durvalumab Plus Vaccine Therapy Elicits ‘Encouraging’ DFS in BCG-Unresponsive NMIBC

January 9th 2025

Durvalumab plus vaccine therapy demonstrated evidence of preliminary antitumor activity without substantial additive toxicity in BCG-unresponsive NMIBC.

FDA Releases Draft Guidance on Tissue Biopsies in Clinical Trials

January 8th 2025

The FDA has issued a draft guidance offering recommendations regarding tissue biopsies in clinical trials for pediatric and adult patients.

Multidisciplinary Collaboration Is Crucial in Managing Ocular Toxicities of Mirvetuximab Soravtansine in Gynecologic Tumors

January 8th 2025

Rebecca Arend, MD, and Kathryn Lyle, CRNP, discuss their approach to managing ocular and other treatment-related toxicities associated with mirvetuximab soravtansine.

Dana-Farber Launches Center for RAS Therapeutics to Target the RAS Oncogene in Cancer

January 8th 2025

Dana-Farber Cancer Institute will launch the Center for RAS Therapeutics to advance scientific investigation and clinical care for RAS-driven cancers.

Phase 3 Study of Ameluz-PDT in Superficial Basal Cell Carcinoma Reaches 1-Year Follow-Up to Support FDA sNDA Submission

January 8th 2025

The phase 3 ALA-BCC-CT013 study of Ameluz and RhodoLED PDT in sBCC had its last enrolled patient complete a 1-year follow-up visit.

Invikafusp Alfa Receives FDA Fast Track Designation for TMB-High CRC

January 8th 2025

Phase 1 data showed the potential for invikafusp alfa as a precision cancer immunotherapeutic agent in solid tumors after exposure to PD-(L)1 therapy.

China’s NMPA Approves Enfortumab Vedotin Plus Pembrolizumab in Advanced Urothelial Cancer

January 8th 2025

Enfortumab vedotin-efjv plus has received NMPA approval for patients with locally advanced or metastatic urothelial cancer.

Fixed-Duration Zanubrutinib/Venetoclax Shows Efficacy in R/R Chronic Lymphocytic Leukemia

January 8th 2025

Fixed-duration zanubrutinib/venetoclax elicited responses in patients with relapsed/refractory chronic lymphocytic leukemia.

FDA Issues Draft Guidance for Accelerated Approval Confirmatory Clinical Trials

January 8th 2025

The FDA released a draft guidance document detailing their interpretation of when a confirmatory clinical trial for an accelerated approval is underway.

TiNivo-2 Data Underscore Challenges With ICI Retreatment in Advanced RCC

January 8th 2025

Toni Choueiri, MD, details the PFS outcomes and safety profiles for tivozanib plus nivolumab vs tivozanib alone in metastatic renal cell carcinoma

Retifanlimab Emerges as Potential New SOC in Advanced SCAC

January 7th 2025

Sheela Rao, MBBS, MD, FRCP, discusses data from the phase 3 POD1UM-303/InterAACT 2 trial of retifanlimab plus chemotherapy vs chemotherapy in advanced SCAC.

Novel BTK Degrader NX-5948 Yields High Response Rates in Pretreated CLL/SLL

January 7th 2025

Nirav N. Shah, MD, MSHP, details how BTK degraders could fill an unmet need in pretreated CLL/SLL and highlights promising data seen with NX-5948.

Mount Sinai Researchers Identify Six-Gene Pattern to Predict Drug Success in Multiple Myeloma Patients

January 7th 2025

Genetic markers for venetoclax could help personalize treatment and improve outcomes

EU Approval Is Sought for Eflornithine in High-Risk Neuroblastoma

January 7th 2025

A marketing authorization application has been submitted to the EMA seeking the approval of eflornithine for patients with high-risk neuroblastoma.

Sunvozertinib Under FDA Priority Review for NSCLC With EGFR Exon 20 Insertion Mutations

January 7th 2025

The FDA has granted priority review to sunvozertinib for advanced/metastatic NSCLC with EGFR exon 20 insertion mutations after progression on chemotherapy.

Amivantamab Plus Lazertinib Improves OS in EGFR-Mutant Advanced NSCLC

January 7th 2025

Amivantamab plus lazertinib prolonged overall survival vs osimertinib as first-line therapy in locally advanced or metastatic, EGFR-mutant NSCLC.

Flonoltinib Maleate Provides Durable Spleen Reduction and Symptom Improvement in Myelofibrosis

January 7th 2025

Flonoltinib maleate generated rapid clinical benefits, including spleen volume reduction and symptom improvement, for patients with myelofibrosis.

Luspatercept/Lenalidomide Combo Demonstrates Safety and Early Efficacy in Lower-Risk, Non-Del(5q) MDS

January 7th 2025

Lenalidomide plus luspatercept demonstrated safety, tolerability, and efficacy in patients with non-del(5q) myelodysplastic syndrome.

WT-7 Shows Acceptable Safety Profile in Relapsed/Refractory T-ALL/LBL

January 7th 2025

Armin Ghobadi, MD, discusses the safety profile of WT-7 in heavily pretreated relapsed/refractory T-ALL and LBL.