March 2026 Brief

FDA grants tentative approval to PNT2003, a Lutathera radioequivalent PRRT for SSTR+ GEP-NETs, paving way for wider access by 2026.

The FDA approves a new formulation of piflufolastat F 18, enhancing prostate cancer imaging with improved efficiency and patient access.

FDA grants priority review to T-DXd for high-risk HER2-positive early breast cancer with residual disease, after trial shows markedly better recurrence-free survival than T-DM1.

A supplemental Biologics License Application has been submitted for nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors.

FDA signals accelerated path for givastomig in CLDN18.2+ gastric/GEJ cancer, as phase 1b data show strong responses and tolerability.

FDA clears MyChoice CDx to find HRD-positive advanced ovarian cancer patients for niraparib, using BRCA and genomic instability testing.

FDA grants orphan drug status to irinotecan ChemoSeed implant for high-grade gliomas, enabling sustained local brain tumor therapy and accelerating pivotal trials.

FDA approves nivolumab with AVD for Hodgkin lymphoma, showing superior survival rates and reduced toxicity compared to existing treatments.

FDA approves relacorilant for platinum-resistant ovarian cancer, showing significant survival benefits without added safety risks in clinical trials.

FDA fast tracks TRI-611, an ALK molecular glue degrader for refractory ALK+ NSCLC. Phase 1/2 trial targets resistance after 2 or more TKIs.

FDA backs pivotal phase 3 plan for VCN-01 plus chemo in metastatic pancreatic cancer, building on phase 2 VIRAGE trial success.

FDA pushes LNTH-2501 decision to June 2026 for manufacturing review.

ZW191 is engineered to bind to FRα, a cell-surface protein with high expression across several tumor types.

The oral FGFR2 inhibitor lirafugratinib is being reviewed by the FDA for the second-line treatment of cholangiocarcinoma harboring FGFR2 alternations.