Caroline Seymour

Darolutamide plus ADT improved radiologic PFS vs placebo plus ADT in men with metastatic hormone-sensitive prostate cancer enrolled in the phase 3 ARANOTE trial.

Up to 12 months of treatment with SGX301 produced lesion responses in patients with early-stage cutaneous T-cell lymphoma.

The BLA seeking approval for remestemcel-L for children with steroid-refractory acute graft-vs-host-disease has been resubmitted to the FDA.

Tislelizumab plus chemotherapy improved OS in patients with unresectable esophageal squamous cell carcinoma and a CPS or TAP score of at least 1 vs 1%.

Liver transplantation plus chemotherapy demonstrated no concerning safety signals or long-term deterioration in QOL in patients with definitively unresectable CRC liver metastasis.

The EMA’s CHMP has recommended a conditional marketing authorization for epcoritamab for patients with relapsed/refractory follicular lymphoma.

Osimertinib received approval in China in combination with pemetrexed and platinum-based chemotherapy for patients with advanced EGFR-mutant NSCLC.

The FDA has approved adagrasib plus cetuximab for patients with KRAS G12C–mutant locally advanced or metastatic colorectal cancer.

Capivasertib plus paclitaxel did not improve OS vs paclitaxel in locally advanced or metastatic TNBC or patients with PIK3CA, AKT1, or PTEN alterations.

Patients with essential thrombocythemia who progressed to myelofibrosis had longer duration of disease, higher white blood cell counts, and lower hemoglobin levels at enrollment.

Frontline toripalimab plus bevacizumab improved progression-free survival and overall survival vs sorafenib in patients with advanced hepatocellular carcinoma.

Mirvetuximab soravtansine led to an ORR of 51.9% in heavily pretreated patients with FRα-positive, platinum-sensitive ovarian cancer.

Trastuzumab deruxtecan improved responses and survival vs T-DM1 in HER2+ metastatic breast cancer after prior exposure to trastuzumab and a taxane.

The European Medicines Agency’s CHMP has recommended the approval of frontline osimertinib plus chemotherapy for EGFR-mutated non–small cell lung cancer.

In a phase 2 trial, all 42 patients with locally advanced mismatch repair–deficient rectal cancer achieved clinical complete response with dostarlimab.

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for Avzivi, a monoclonal antibody referencing bevacizumab.

Integrating liver transplantation into treatment with chemotherapy improved survival at 5 years vs chemotherapy alone in patients with definitively unresectable CRC liver metastases.

Frontline rivoceranib plus camrelizumab continued to show a significant improvement in OS vs sorafenib in advanced unresectable hepatocellular carcinoma.

The FDA granted priority review to an sBLA seeking the approval of pembrolizumab plus chemotherapy as frontline therapy in malignant pleural mesothelioma.

Two biosimilars for reference denosumab have received marketing authorization from the European Commission.

The FDA has granted accelerated approval to tarlatamab for the treatment of patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.

Vepdegestrant plus palbociclib maintained clinical efficacy and safety in patients with pretreated, advanced ER-positive, HER2-negative breast cancer.

Pertuzumab plus trastuzumab produced antitumor activity and a mild adverse effect profile in patients with pretreated biliary tract cancer with ERBB2/3 alterations.

Capecitabine or XELOX failed to improve OS at 2 years vs fluorouracil/cisplatin as DCRT in inoperable locally advanced esophageal squamous cell carcinoma.

Salvage treatment with nivolumab plus ipilimumab following progression on nivolumab alone led to significant treatment-free survival in advanced ccRCC.

Health Canada has approved an sNDA for goserelin acetate 10.8 mg every 12 weeks for ER-positive early breast cancer with a high risk of recurrence or advanced breast cancer.

The FDA has approved trastuzumab-strf for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or GEJ adenocarcinoma.

CTX-009 plus paclitaxel has received FDA fast track designation for pretreated metastatic or locally advanced biliary tract cancer.

The FDA has mandated that the boxed warning for all approved CAR T-cell therapies be updated to include the serious risk of T-cell malignancies.

Adjuvant nivolumab extended DFS, NUTRFS, and DMFS vs placebo and showed for the first time an improvement in OS in patients with high-risk muscle-invasive urothelial cancer.