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Your AI-Trained Oncology Knowledge Connection!
Jordyn Sava is an editor for Targeted Oncology.
FDA Clears IND Application for CLD-201 in Solid Tumors
The FDA has granted clearance to an investigational new drug application for CLD-201 for solid tumor treatment, based on preclinical findings.
Well-Tolerated TLX101 Shows Efficacy in Recurrent Glioma
Preliminary results from the phase 2 IPAX-Linz study show encouraging efficacy and a favorable safety profile for TLX101 in recurrent high-grade glioma.
FDA to Review Nogapendekin Alfa in Bladder Cancer and Lymphopenia
A supplemental biologics license application has been submitted to the FDA for nogapendekin alfa plus Bacillus Calmette-Guérin in papillary non-muscle invasive bladder cancer.
Predicting Palbociclib Outcomes in Breast Cancer Using Deep Learning
Xiaojie Zhang, MD, and Akshat Singhal, PhD, discuss their research leveraging deep learning to predict how patients with ER+/HER2- breast cancer will respond to palbociclib.
Novel Radioenhancer JNJ-1900 Shows Potential Across Cancers
Jared Weiss, MD, discussed the mechanism of action of JNJ-1900 and the preliminary data presented at the 2025 European Lung Cancer Congress.
Savolitinib/Osimertinib Yields Durable Responses in EGFR-Mutated, MET+ NSCLC
The phase 2 SAVANNAH trial of savolitinib plus osimertinib has demonstrated the combination’s efficacy and safety in EGFR-mutated NSCLC.
SGX301 Shows Rapid and Durable Responses in Early-Stage CTCL
SGX301 has shown rapid and sustained benefit in early cutaneous T-cell lymphoma in an investigator-initiated study, with good safety.
FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma
Following a recent Type D meeting with the FDA, a phase 3 clinical trial design for darovasertib in primary uveal melanoma has been announced.
First Patient Receives KSQ-004EX for Advanced Cancer
A phase 1/2 trial of CRISPR-engineered eTIL therapy KSQ-004EX for advanced solid tumors has dosed its first patient.
Gene Expression Test Accurately Predicts Low SLN Positivity Risk in Melanoma
The DecisionDx-Melanoma test accurately identifies low sentinel lymph node risk in melanoma, according to the DECIDE study.
COA Advocates for Biomarker Testing Access, Physician Autonomy in Cancer Care
Nicolas Ferreyros discussed central ideas from the Community Oncology Alliance to optimize cancer care in community oncology settings.
Tarlatamab Shows Significant OS Improvement in Post-Platinum SCLC
Tarlatamab outperformed chemotherapy when used for the treatment of patients with small cell lung cancer in the phase 3 DeLLphi-304 trial.
FDA Approves Nivolumab/Ipilimumab in First-Line Hepatocellular Cancer
Findings from the CheckMate 9DW trial support the FDA approval of nivolumab and ipilimumab in unresectable hepatocellular carcinoma
CT-95 Phase 1 Trial Enrolls and Doses First Patient With MSLN+ Advanced Cancer
A phase 1 open-label trial is underway, evaluating the safety and efficacy of CT-95 in patients with mesothelin-expressing advanced solid tumors.
Teclistamab Combo Yields Deep Responses in Newly Diagnosed Myeloma
Marc Raab, MD, PhD, discussed the MajesTEC-5 trial of teclistamab plus standard myeloma therapies in transplant-eligible newly diagnosed multiple myeloma.
FDA Greenlights Bevacizumab Biosimilar Across Cancer Types
The FDA has approved bevacizumab-nwgd, a biosimilar to bevacizumab, for intravenous use across multiple cancer types.
FDA Awards Full Approval to Larotrectinib in NTRK+ Solid Tumors
The FDA has fully approved larotrectinib for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion.
Safety Committee Backs PH-762 Dose-Escalation in Skin Cancer Trial
A phase 1b trial is evaluating PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma.
FDA Clears ZEISS INTRABEAM 700 for IORT in Cancer Surgery
The FDA has granted 501(k) clearance to ZEISS INTRABEAM 700, a robotic-assisted platform designed to enhance intraoperative radiation therapy.
FDA Approves Nivolumab/Ipilimumab Combo in MSI-H/dMMR mCRC
Based on data from the phase 3 CheckMate-8HW trial, the combination of nivolumab and ipilimumab has been approved by the FDA in metastatic colorectal cancer.
FDA Clears IND Application for ST-001 in SCLC
ST-001, an intravenous nanoformulation of fenretinide, will be evaluated in a phase 1a/1b small cell lung cancer trial.
FDA Receives New Drug Application for Ziftomenib in NPM1-Mutant R/R AML
Ziftomenib’s FDA application for relapsed/refractory NPM1-mutant acute myeloid leukemia is supported by data from the KOMET-001 trial.
Strong 1-Year Survival Shown With MMUD Peripheral Blood Stem Cell Transplants
Jeff Auletta, MD, discussed the ACCESS trial and explained that mismatched unrelated donor transplants can be a viable option.
FDA Advances ALX2004 to Phase 1 Trials in EGFR+ Solid Tumors
The FDA cleared the investigational new drug application for ALX2004, with phase 1 trials expected to begin in mid-2025 for EGFR+ solid tumors.
Paige PanCancer Detect Earns FDA Designation for Multi-Tissue Cancer Detection
Paige PanCancer Detect has gained FDA breakthrough device designation, a first for AI identifying diverse cancers across tissues.
Addressing Treatment Gaps in High-Risk CML in Blast Phase
Akriti Jain, MD, discussed how emerging data on non-ABL1 mutations is reshaping chronic myeloid leukemia management.
Tovecimig Plus Paclitaxel Improves ORR in Advanced Biliary Tract Cancer
The primary end point of overall response rate has been met in the COMPANION-002 trial of tovecimig and paclitaxel in advanced biliary tract cancer.
FDA OKs Phase 3 Study of Linperlisib in Peripheral T-Cell Lymphoma
Following a successful Type B end-of-phase 2 meeting, the FDA has approved the start of a phase 3 trial of linperlisib in peripheral T-cell lymphoma.
Dr Galsky on Durvalumab's FDA Approval in Muscle-Invasive Bladder Cancer
Matt Galsky, MD, delved into the recent approval of a perioperative durvalumab regimen in muscle-invasive bladder cancer.
FDA Approves IDE Application for Alpha DaRT in Recurrent Glioblastoma
A pilot study will evaluate Alpha DaRT for the treatment of patients with recurrent glioblastoma.