Jason M. Broderick

The FDA will use the extension to review additional data supporting the NDA for zanzalintinib plus atezolizumab for metastatic colorectal cancer.

Geoffrey Y. Ku, MD, highlights emerging therapies in the treatment paradigm for patients with gastric and gastroesophageal junction cancers.

The approval is primarily supported by the phase 3 VERIFY study.

Shubham Pant, MD, MBBS, explains the significance of the FDA approval of daraxonrasib for mPDAC.

Varsetatug masetecan is a first-in-class ADC that pairs a monoclonal antibody against EpCAM with a topoisomerase 1 inhibitor payload.

The approval of daraxonrasib in pancreatic cancer is supported by results from the phase 3 RASolute 302 trial.

The sBLA for dostarlimab in dMMR/MSI-H rectal cancer is based on the AZUR-1 trial.

"Although I am disappointed that the PFS improvement was not statistically significant, I look forward to continuing to follow these results," Robert Coleman, MD.

The sBLA for subcutaneous amivantamab is supported by results from the phase 1b/2 OrigAMI-4 study.

Sonesitatug vedotin boosted overall survival vs chemotherapy in second-line and later CLDN18.2-positive gastric/GEJ cancers.

Early phase 2 data show IMNN-001 added to chemo plus bevacizumab reduces residual ovarian cancer, boosts ctDNA clearance, and remains well tolerated.

The NDA for daraxonrasib in PDAC is supported by results from the phase 3 RASolute 302 trial.

The 100% response rate for the combination was achieved in older patients with locally advanced or metastatic head and neck squamous cell carcinoma.

Dostarlimab previously received breakthrough therapy designation from the FDA for dMMR/MSI-H rectal cancer.

This is the third complete response letter the FDA has issued for rivoceranib plus camrelizumab for hepatocellular carcinoma.

The results jeopardize the accelerated approval of adagrasib plus cetuximab for KRAS G12C–mutated mCRC.

Building on these data, the ongoing phase 3 BATTMAN trial is exploring botensilimab plus balstilimab in refractory MSS mCRC.

The next-generation KRAS G12C inhibitor improved survival vs the approved first-generation agents sotorasib and adagrasib.

The zoldonrasib data build on the recent historical breakthrough with daraxonrasib in PDAC.

It was previously shown that the STELLAR-303 trial achieved the coprimary end point of OS in the ITT population.

An ongoing dose expansion phase of the trial is evaluating CRB-701 plus pembrolizumab for first-line OPSCC.

The patients with HNSCC had already been treated with immune checkpoint inhibitors and platinum-based chemotherapy.

Ofirnoflast is a first-in-class oral allosteric modulator of NEK7 that previously received FDA orphan drug designation.

A phase 3 trial of givastomig is expected to begin as early as the fourth quarter of 2026.

The FDA concurrently cleared the VENTANA PTEN (SP218) RxDx assay as a companion diagnostic to identify eligible patients.

EPCORE FL-1 data showed a consistent benefit with epcoritamab-based treatment in follicular lymphoma.

The supplemental biologics license application is supported by the phase 3 ATOMIC trial.

"DISC-0974 treatment resulted in sustained hepcidin and serum iron, regardless of concomitant JAKi therapy or baseline transfusion requirement,” said Naseema Gangat, MBBS.

"Sacituzumab govitecan plus pembrolizumab [led to] improvement in PFS2...despite the crossover design of the trial," said Eleonora Teplinsky, MD.

A review of top ASCO abstracts with the potential to change everyday oncology practice.