Chris Ryan

The FDA has lifted a partial clinical hold on the phase 1 trial evaluating YL202 in advanced breast cancer and EGFR-mutated non–small cell lung cancer.

The EMA has validated a type II variation application for trastuzumab deruxtecan for select patients with HER2-low or -ultralow metastatic breast cancer.

The FDA has approved neoadjuvant durvalumab plus chemotherapy, followed by adjuvant durvalumab, for select resectable non–small cell lung cancer.

The FDA granted priority review to durvalumab in limited-stage small cell lung cancer after platinum-based concurrent chemoradiotherapy.

Treatment with VP-315 led to reductions in tumor size in patients with basal cell carcinoma.

Enrollment will discontinue for the SELECT-AML-1 trial of tamibarotene/venetoclax/azacitidine in newly diagnosed, RARA-positive acute myeloid leukemia.

CIRT plus durvalumab and tremelimumab was safe in patients with advanced hepatocellular carcinoma with macrovascular invasion.

Isatuximab plus VRd induction improved progression-free survival in transplant-eligible, newly diagnosed multiple myeloma.

The KeyVibe-008 trial evaluating vibostolimab, pembrolizumab, and chemotherapy in extensive-stage small cell lung cancer has been discontinued.

The FDA has approved denileukin diftitox-cxdl for relapsed/refractory cutaneous T-cell lymphoma after at least 1 prior systemic therapy.

The FDA has approved vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.

The FDA cleared the SeCore CDx HLA A Sequencing System as a companion diagnostic for afamitresgene autoleucel in advanced synovial sarcoma.

EO-3021 was safe and led to responses in advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2.

Pirtobrutinib generated responses in BTK inhibitor–naive relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.

The European Medicines Agency has granted orphan drug designation to SLS009 for relapsed/refractory peripheral T-cell lymphoma

The FDA has accepted a supplemental new drug application for cabozantinib in advanced pancreatic and extra-pancreatic neuroendocrine tumors.

The FDA has granted accelerated approval to afamitresgene autoleucel for select patients with pretreated unresectable or metastatic synovial sarcoma.

The FDA has approved dostarlimab plus carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer.

The EMA has granted orphan medicinal product designation to rivoceranib plus camrelizumab in first-line unresectable hepatocellular carcinoma.

The FDA granted fast track designation to IMM-1-104 for first-line pancreatic ductal adenocarcinoma.

The European Medicines Agency has approved Avzivi, a biosimilar referencing bevacizumab.

IMNN-001 plus perioperative chemotherapy improved overall survival in newly diagnosed, advanced ovarian cancer.

China’s NMPA has accepted an sBLA for ivonescimab in first-line, PD-L1–positive non–small cell lung cancer.

The EMA’s CHMP has recommended toripalimab plus chemotherapy for metastatic nasopharyngeal carcinoma and advanced esophageal squamous cell carcinoma.

The EMA’s CHMP has recommended the approval of amivantamab plus chemotherapy for pretreated, EGFR-mutated advanced non–small cell lung cancer.

First-line sugemalimab plus chemotherapy has been approved in Europe for metastatic non–small cell lung cancer.

Crofelemer did not improve the incidence of diarrhea in patients with solid tumors receiving targeted therapy.

Iopofosine I 131 generated a major response rate of 56.4% in patients with relapsed/refractory Waldenström macroglobulinemia.

The FDA has accepted the resubmission of a BLA for remestemcel-L in pediatric steroid-refractory acute graft-vs-host-disease.

Pembrolizumab plus ibrutinib or idelalisib produced responses in patients with Richter transformation of chronic lymphocytic leukemia.