The FDA granted accelerated approval to Replimune's TUDRIQEVTM (vusolimogene oderparepvec-wtpg) for melanoma treatment, reversing two earlier rejections following support from an advisory panel. The approval marks a significant turnaround for the biotech company after a tumultuous regulatory process.
The FDA has approved Novartis' radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for use in combination with hormone therapy for patients with PSMA-positive metastatic prostate cancer who are still hormone-sensitive, nearly doubling the eligible patient population from its previous indication for hormone-resistant cases.
Phase III CLARITY-Gastric01 trial results showed sonesitatug vedotin (Sone-Ve) achieved statistically significant overall survival improvement in CLDN18.2-positive advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma patients in second-line and later settings, meeting its dual primary and key secondary endpoints.
The European Commission has approved AstraZeneca's Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for first-line treatment of adults with ER-positive, HER2-negative advanced breast cancer with emergent ESR1 mutations. The approval is based on SERENA-6 Phase III trial results showing a 56% reduction in risk of disease progression or death.
AstraZeneca and Daiichi Sankyo are nearing a pricing agreement with the UK's National Institute for Health and Care Excellence (NICE) for their breast cancer treatment Enhertu, which could provide access to women in England and Wales with HER2-low breast cancer.
Roche announced positive results from a head-to-head Phase 3 trial showing its KRAS G12C inhibitor divarasib demonstrated superior efficacy compared to competing treatments from Amgen and Bristol Myers Squibb in patients with KRAS-driven lung cancer.
The U.S. FDA has approved Orca Bio's TREGZI, the first precision-engineered cell therapy for allogeneic transplants in adults with hematological malignancies, designed to reduce stem cell transplant complications.
The EPCORE DLBCL-4 Phase 3 trial showed that epcoritamab (Epkinly) combined with lenalidomide significantly improved progression-free survival compared to R-GemOx chemotherapy in adults with relapsed or refractory diffuse large B-cell lymphoma who received at least one prior line of therapy. The results bring the bispecific antibody closer to a potential label expansion.
The FDA approved sacituzumab govitecan-hziy (Trodelvy) on June 24, 2026, for two indications in adults with triple-negative breast cancer: as monotherapy and in combination with pembrolizumab (Keytruda) for first-line treatment of advanced disease, offering new options beyond standard chemotherapy.
The FDA has approved the combination of belzutifan (Welireg) and pembrolizumab (Keytruda) as adjuvant treatment for patients with clear cell renal cell carcinoma at high risk of recurrence following nephrectomy, based on data from the phase 3 LITESPARK-022 trial.
The FDA has rejected RP1, a breakthrough melanoma treatment, twice despite its promise in treating skin cancer. The rejections have left medical professionals puzzled and concerned about implications for future drug approvals.
Global phase III TROPION-Breast02 trial led by National Cancer Centre Singapore shows datopotamab deruxtecan significantly improves survival outcomes in triple-negative breast cancer patients, representing a major breakthrough for this aggressive cancer type.
Researchers have developed artificial intelligence tools to support clinical decision-making in hematologic malignancies, including HemaGuide from German Cancer Research Center for treatment recommendations and AI applications in palliative oncology for symptom management and prognostication.
