Targeted Oncology Staff

The FDA has granted fast track designation to safusidenib, an oral IDH1 inhibitor, based on durable phase 2 J201 study responses in IDH1-mutant glioma.

The FDA has granted breakthrough therapy and fast track designations to 68Ga-NYM096, a PET imaging agent for clear cell renal cell carcinoma.

The FDA has granted fast track designation to PLN-101095 plus pembrolizumab for ICI-refractory advanced or metastatic solid tumors.

During a Community Case Forum event, Manojkumar Bupathi, MD, MS, and participants discussed how drug interactions, cost, and day-to-day tolerability are what separate one ARPI regimen from another in hormone-sensitive prostate cancer.

The FDA has granted fast track designation to BH-30643, an oral OMNI-EGFR inhibitor, for advanced EGFR C797S-positive non–small cell lung cancer after a third-generation TKI.

The FDA has granted fast track designation to ETX-19477, an oral PARG inhibitor, for BRCA-mutated, HR+/HER2– unresectable or metastatic breast cancer.

During a live event, Sudarsan Kollimuttathuillam, MD, and participants discussed how real-world practice for preventing febrile neutropenia in extensive-stage small cell lung cancer often runs ahead of formal risk stratification.

The designation is for sapanisertib/serabelisib (Piktor) plus chemo in patients who have progressed after chemo and an immune checkpoint inhibitor.

AstraZeneca is discontinuing the phase 3 eVOLVE-Lung02 trial after finding volrustomig plus chemotherapy unlikely to meet its primary end points in metastatic NSCLC.

Trastuzumab deruxtecan improved progression-free survival vs chemoimmunotherapy in the phase 3 DESTINY-Lung04 trial in HER2-mutant NSCLC.

Savolitinib plus osimertinib met PFS and OS end points vs chemotherapy in the phase 3 SAFFRON trial of EGFR-mutated, MET-driven NSCLC.

The multicenter PRO B trial found that weekly ePRO monitoring with alert-based nurse contact reduced fatigue vs usual care in metastatic breast cancer.

A secondary analysis of the phase 3 RxPONDER trial found that premenopausal women with low baseline AMH did not benefit from added chemotherapy vs endocrine therapy alone.

"New clinical evidence helps clarify which patients can benefit from radiation therapy,” said Daniel Chang, MD.

NeOnc's intranasal NEO100 met its primary end point in a phase 2a trial of recurrent IDH1-mutant glioma, reaching 48.9% 6-month PFS vs a 20% benchmark.

Zipalertinib plus platinum-based chemotherapy significantly improved progression-free survival at a planned interim analysis of the phase 3 REZILIENT3 trial.

During a live event, Eric K. Singhi, MD, and participants discussed how CNS activity and cumulative toxicity, not guideline listing alone, are shaping frontline treatment selection in ROS1-positive advanced NSCLC.

The FDA has granted breakthrough device designation to Freenome's SimpleScreen Lung, an investigational blood-based test for high-risk lung cancer screening.

Experts weigh response speed, survival and quality of life to choose first-line IO-TKI or dual immunotherapy for metastatic clear cell RCC.

This analysis builds on results from the phase 3 KEYNOTE-689 trial of perioperative pembrolizumab in head and neck squamous cell carcinoma.

The complete response letter did not cite any clinical issues regarding the NDA for 177Lu-edotreotide for GEP-NETs.

During a live event, Sikander Ailawadhi, MD, and participants discussed how the route of CD38-antibody delivery, including a newly approved on-body injector, is shaping frontline regimen selection for transplant-ineligible multiple myeloma.

The FDA's Molecular and Clinical Genetics Panel will meet Sept. 23, 2026, to evaluate GRAIL's premarket approval application for the Galleri MCED test.

A multimodal deep learning model trained in the NSABP B-42 trial and validated in TAILORx predicted late distant recurrence risk in HR-positive breast cancer.

Neoadjuvant inetetamab plus pyrotinib and chemotherapy achieved a 60.2% total pathologic complete response rate in the phase 2 neoPICD trial.

Explore how REMS removal streamlines CAR T-cell access in second-line DLBCL, plus smart bridging options and who qualifies when relapse strikes fast.

Large Ontario cohort study finds lifetime breast and ovarian cancer risk varies sharply by BRCA1/BRCA2 test result, including in those with inconclusive or negative findings.

Experts weigh TiNivo-2 and CONTACT-03, urging caution on PD-1 rechallenge in RCC and guiding tivozanib vs cabozantinib choices.

Jazz moves to drop Zepzelca’s second-line SCLC use after LAGOON misses survival, while first-line maintenance combo remains approved.

During a live event, Millie Das, MD, and participants discussed why the case for adding a CTLA-4 inhibitor in PD-L1–low metastatic NSCLC does not hold uniformly once histology is taken into account.