
Orca-Q Receives FDA RMAT Designation for High-Risk Hematologic Malignancies.

Orca-Q Receives FDA RMAT Designation for High-Risk Hematologic Malignancies.

The FDA cleared vepdegestrant in ER+ breast cancer with ESR1 mutations, ODAC voted on key questions in breast and prostate cancer, and more.

The FDA has approved a once-daily, extended-release formulation of ruxolitinib for select myelofibrosis, polycythemia vera, and graft-vs-host disease.

The FDA has permitted expanded access to daraxonrasib for patients with previously treated metastatic pancreatic ductal adenocarcinoma.

Nivolumab plus cabozantinib was safe and active for the real-world frontline treatment of patients with advanced RCC.

Read a refresh of the top FDA news in breast cancer from April 2026, including an ODAC decision and a breakthrough device designation.

The FDA approved vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least 1 line of endocrine therapy.

Researchers are optimistic about epigenetic tools for studying the impact of environmental exposures on genes, but further investigations are needed before drawing conclusions on the causes of early-onset colorectal cancer.

Did you catch all of this week's top oncology news? Test your knowledge with OncLive's Weekly News Quiz.

Alan L. Ho, MD, PhD, discusses the unique elements of Oz-V that may contribute to its efficacy and tolerability in OPSCC.

The FDA ODAC voted for the use of capivasertib plus abiraterone in PTEN-deficient mHSPC.

Mayo Clinic researchers developed a blood-based method that may help detect germ cell tumors.

The FDA ODAC voted against the clinical benefit of switching to camizestrant after the emergence of an ESR1 mutation in HR-positive breast cancer.

Capivasertib plus abiraterone produced superior efficacy outcomes vs abiraterone alone in PTEN-deficient mHSPC.

The April 30, 2026, FDA ODAC meeting will focus on data from SERENA-6 for camizestrant in hormone receptor–positive, ESR1-mutated advanced breast cancer.

Ozekibart plus FOLFIRI produced ORRs that exceed historical benchmarks for standard later-line CRC regimens.

The April 30, 2026, FDA ODAC meeting will focus on data from CAPItello-281 for capivasertib plus abiraterone in PTEN-deficient mHSPC.

Elranatamab improved PFS vs SOC combination therapy in relapsed/refractory multiple myeloma, meeting the primary end point of the MagnetisMM-5 trial.

A preclinical study reveals that impaired functioning of 2 enzymes contributes to the development and progression of precancerous lesions in the pancreas.

An NDA seeking the approval of varegacestat for the treatment of adult patients with desmoid tumors has been submitted to the FDA.

Alyssa Schatz, DrPH, discusses the new NCCN Advocacy Academy program for oncology fellows and junior faculty.

Peter Enzinger, MD, discusses diagnostic pathways, the role of surgery, and ongoing trials of interest in esophageal cancer in this clinician-focused FAQ.

A data monitoring committee recommended halting the phase 3 FLASH2 trial investigating HyBryte in CTCL due to futility.

iSCIB1+ has received fast track designation from the regulatory agency as a potential therapeutic options for patients with advanced melanoma.

The investigational pan-RAS inhibitor generated robust responses across 2 phase 1 dose-escalation studies that numerically exceeded historical benchmarks.


The regulatory agency has set a PDUFA action date of February 27, 2027, for zipalertinib in locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

The FDA has granted breakthrough therapy designation to TERN-701 for the treatment of Ph-positive chronic myeloid leukemia in chronic phase.

Rena D. Callahan, MD, discusses questions regarding treatment sequencing with CDK4/6 inhibitors and ADCs in hormone receptor–positive breast cancer.

Stefan K. Barta, MD, MS, discusses the CTCL subtype mycosis fungoides, common adverse effects, and optimal treatment approaches.