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FDA ODAC Votes in Favor of Risk:Benefit Profile of Capivasertib Plus Abiraterone in PTEN-Deficient mHSPC

Blood Test Shows Promise for Detecting Testicular Cancer When Standard Markers Miss
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FDA ODAC Live Updates: Committee Reviews SERENA-6 Data for Camizestrant in ESR1-Mutated, Hormone Receptor+ Breast Cancer
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.

FDA ODAC Live Updates: Committee Weighs Data for Capivasertib Plus Abiraterone in PTEN-Deficient mHSPC
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.

QLS5132 led to a 50% ORR and manageable safety in PROC, supporting CLDN6 as a promising ADC target in early-phase clinical development.

Tovecimig plus paclitaxel improved PFS vs paclitaxel alone in COMPANION-002, though crossover effects complicated OS outcomes.

Dana-Farber Cancer Institute announced a gift to support cancer prevention and establish the Larry and Susan Marx Chair for Early Detection.

The agency has set a target action date of August 25, 2026, for the sBLA, which is supported by data from the phase 3 HERIZON-GEA-01 trial.

Frontline treatment with zovegalisib, atirmociclib, and fulvestrant yielded responses in pretreated, PI3Kα-mutated HR-positive metastatic breast cancer.

Mina M. Fam, MD, and Bradley McGregor, MD, discuss the treatment landscape of testicular cancer during Testicular Cancer Awareness Month.

Breast cancer experts discuss nuances of using CDK4/6 inhibitors to treat patients with high-risk hormone receptor–positive, HER2-negative early disease.

In her latest OncologyFellows column, Jill Gilbert, MD, discusses how oncologists can influence large health care decisions and policy.

The top 5 OncLive TV videos of the week cover insights in head and neck cancer, esophageal cancer, renal cell carcinoma, and breast cancer.































































