Sabrina Serani

FDA extends camizestrant review as ctDNA-guided ESR1 switch sparks debate; new analyses debut at ASCO while Europe advances approval.

Data from the PANKU-Breast02 trial may support iza-bren as a new standard of care in this TNBC population.

Data from the VIKTORIA-1 trial support the PAM pathway as a molecular driver in HR-positive, HER2-negative breast cancer of any PIK3CA mutation status.

"The VIKTORIA-1 trial validates the PAM pathway as a molecular driver in hormone receptor–positive, HER2-negative advanced breast cancer, regardless of PIK3CA mutation status," said Sara Hurvitz, MD.

The FDA approved Lupin and Natco’s generic eribulin mesylate for pretreated metastatic breast cancer and unresectable or metastatic liposarcoma.

FDA clears US enrollment for ateganosine plus cemiplimab in third-line NSCLC, testing telomere-targeting therapy after checkpoint and chemo failure.

FDA granted RMAT designation to lasme-cel, a CD22-targeting allogeneic CAR-T, for R/R B-ALL, the first such therapy in a pivotal trial for this indication.

Alembic receives tentative FDA approval for generic larotrectinib capsules, a TRK inhibitor for NTRK fusion–positive solid tumors, with potential 180-day exclusivity.

FDA accepted a priority-review sBLA for atezolizumab (IV or SC with hyaluronidase) plus mFOLFOX6 as adjuvant therapy after R0 resection in stage III dMMR/MSI-H colon cancer. ATOMIC showed 3-year DFS 86.3% vs 76.2% (HR 0.50), with consistency across nodal, T-stage, and location strata; findings held in per-protocol and centrally confirmed dMMR analyses.

Real-world data show tarlatamab achieved 27.7% ORR and manageable toxicity in heavily pretreated patients with ES-SCLC with brain metastases at a single academic center.