Ashling Wahner

Dibotatug was deemed tolerable and produced robust responses across subgroups of patients with relapsed/refractory cytotoxic T/NK cell lymphomas.

Key Takeaways Most patients experienced at least one adverse effect, predominantly flu-like symptoms and cytopenias, with mood changes in approximately 10% and other events uncommon (≤3% each). Toxicities were overwhelmingly grade 1–2, with grade 3 events in 8% and a single grade 4 severe neutropenia, generally mitigated via supportive care, dose reduction, or discontinuation. Discontinuation occurred in 68%, yet only 35% of cessations were attributed to adverse effects; progression, unrelated death, cost, and patient preference were notable drivers. Dosing varied widely (18–180 µg weekly; median 72 µg), and pegylated interferon alfa-2a was commonly deployed in combination regimens across a broad stage distribution. Concomitant treatment patterns frequently included topical steroids, oral bexarotene, extracorporeal photopheresis, UV-based therapies, cytotoxic topicals, mogamulizumab, and radiotherapy modalities. SHOW MORE

Highlights From the Evolving First-Line HER2+ Treatment Paradigm

Key Takeaways FDA issued a CRL for LNTH-2501 due to unresolved third-party manufacturing inspection conditions, with no cited safety, efficacy, or clinical data deficiencies. Phase 1/2 NCT01619865 showed Ga-68 edotreotide PET/CT achieved ~90% positive and 86%–89% negative agreement versus reference standards, outperforming Octreoscan SPECT plus contrast CT. In phase 2 NCT01869725, PET/CT demonstrated 90%–92% positive and 75% negative percent agreement against composite reference, in 59 evaluable patients with NETs or other SSTR-positive tumors. LNTH-2501 would ship as a two-vial radiopharmacy kit enabling on-site preparation of Ga-68 edotreotide from generator eluate for PET localization of SSTR-positive NETs. SHOW MORE

Key Takeaways Estrogen blockade produces a conglomerate metabolic phenotype that increases diabetes and cardiometabolic mortality risk, supporting adjunctive strategies rather than de-escalation of endocrine therapy. Weight gain vulnerability extends beyond BMI; higher adiposity at normal BMI predicts recurrence risk, motivating development of fat and metabolic signatures for precision risk stratification. Obesity, hyperinsulinemia, and high body-fat levels correlate with recurrence across ER-positive, HER2-positive, and triple-negative disease, suggesting metabolic remediation could amplify chemotherapy's survival benefit. Precision lifestyle prescriptions should define the exercise indication first, then tailor modality and dose, using ramp-up periods and allied health support to overcome fatigue-related activation energy barriers. GLP-1 receptor agonists appear acceptable during endocrine therapy and survivorship, but initiation during cytotoxic or immunotherapy warrants caution due to overlapping GI toxicities and potential treatment-delivery compromise. SHOW MORE

Breast oncologists weigh the future role of radiographic progression vs liquid biopsy in the timing of therapeutic shifts in metastatic breast cancer.

The FDA gave a CRL to the NDA seeking the approval of Orviglance for use in the detection of liver metastases in patients with severe kidney impairment.

Key Takeaways Access to patient-level data enabled prespecified matching of DCVax‑L recipients to external controls from three newly diagnosed GBM randomized trials, replacing earlier cohort-level comparator methodology. Propensity score matching across known prognostic variables yielded median OS improvements of 4.9–6.3 months versus two trials and 3.4–3.7 months versus a third; HR 0.69–0.77. Inverse probability weighting produced concordant survival gains of 3.4–4.3 months with nominal significance, reinforcing consistency across analytic approaches despite reliance on nonconcurrent external control populations. Rosenbaum's Gamma and E-value sensitivity analyses suggested unmeasured confounding would need to be substantial to nullify the observed effect, supporting robustness of the survival signal. Earlier external-control comparisons reported median OS 19.3 vs 16.5 months in newly diagnosed GBM and 13.2 vs 7.8 months in recurrence, with doubled long-term survival rates. SHOW MORE

Read a refresh of breast cancer FDA news from June 2026, including several practice-changing approvals and the granting of priority review to a SERD.

Key Takeaways Phase 3 RASolute 302 showed daraxonrasib improved median OS to 13.2 vs 6.6 months in RAS G12–mutant metastatic PDAC (HR, 0.40), supporting second-line adoption. ADC strategies expanded: Dato-DXd requires proactive mucositis prophylaxis, while sacituzumab govitecan offers an alternative when ocular risk or mucositis concerns outweigh diarrhea/neutropenia tradeoffs. FDA actions reinforced earlier, more convenient therapy, including all-oral decitabine/cedazuridine plus venetoclax for newly diagnosed AML and neoadjuvant/post-neoadjuvant T-DXd indications in early-stage HER2+ breast cancer. ctDNA was positioned as a tool for residual disease and resistance monitoring in GI cancers and as a trigger for pre-radiographic endocrine switching in SERENA-6, raising outcome and QoL questions. Myeloma discussions centered on optimizing bispecifics, CAR T placement, and quadruplet regimens, while emphasizing community access and toxicity literacy as prerequisites for broad uptake of T-cell–redirecting therapies. SHOW MORE