Chris Ryan

BXQ-350 was well tolerated and generated clinical activity in patients with advanced solid tumors.

A rolling NDA seeking the approval of avutometinib plus defactinib in recurrent KRAS-mutant low-grade serous ovarian cancer has been submitted to the FDA.

The FDA has granted regenerative medicine advanced therapy to ALLO-316 in CD70-positive advanced or metastatic renal cell carcinoma.

The FDA has extended the PDUFA date for sotorasib plus panitumumab application in KRAS G12C+ metastatic colorectal cancer.

The FDA has received an NDA seeking the approval of a 3-month formulation of leuprolide mesylate for advanced prostate cancer.

The FDA has granted accelerated approval to asciminib for newly diagnosed, Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

TYRA-300 was safe and produced antitumor activity in metastatic urothelial cancer harboring FGFR3 alterations.

Pembrolizumab-based combinations have been approved in Europe in 2 new indications for endometrial and cervical cancer.

Fadraciclib was safe and showed signs of efficacy in advanced solid tumors harboring CDKN2A/B alterations.

Treatment with the BTK degrader NX-5948 led to responses in patients with relapsed/refractory Waldenström macroglobulinemia.

The FDA has approved the Ventana CLDN18 (43-14A) RxDx Assay as a companion diagnostic for zolbetuximab in CLDN18.2-positive gastric/GEJ cancer.

Acalabrutinib plus venetoclax and rituximab generated a 100% response rate in treatment-naive mantle cell lymphoma.

The addition of TG4001 to avelumab failed to improve progression-free survival in HPV16-positive cervical and anogenital tumors.

Zolbetuximab wins approval for CLDN18.2-positive gastric/GEJ cancer, TTFields joins the NSCLC armamentarium, and more of this week's top news in oncology.

The FDA approved zolbetuximab plus chemotherapy for advanced, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma.

Gilead will voluntarily withdraw the United States indication for sacituzumab govitecan in metastatic urothelial cancer.

Belzupacap sarotalocan produced complete responses in patients with low-grade non–muscle-invasive bladder cancer.

Updated RAMP 201 data will support an NDA submission to the FDA for avutometinib plus defactinib in recurrent low-grade serous ovarian cancer.

The European Commission has granted orphan medicinal product designation to VCN-01 for the treatment of patients with retinoblastoma.

The FDA has granted rare pediatric disease designation to galinpepimut-S for acute myeloid leukemia.

The FDA has approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel in metastatic non–small cell lung cancer.

The FDA has granted orphan drug designation to IMM-1-104 for pancreatic cancer.

Toripalimab has been approved in India and China’s Hong Kong Special Administrative Region for recurrent or metastatic nasopharyngeal carcinoma.

The DetermaIO gene expression test was predictive of responses to neoadjuvant atezolizumab plus chemotherapy in early-stage triple-negative breast cancer.

The FDA approved inavolisib plus palbociclib/fulvestrant for select PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer.

A Type II variation application has been submitted to the EMA for subcutaneous daratumumab plus VRd in newly diagnosed multiple myeloma.

The combination of talazoparib and enzalutamide improved overall survival in metastatic castration-resistant prostate cancer.

LBL-024 received breakthrough therapy designation in China for pretreated advanced extrapulmonary neuroendocrine carcinoma.

Apalutamide was associated with an improved 24-month overall survival rate vs enzalutamide in metastatic castration-sensitive prostate cancer.

The SunRISe-2 trial of TAR-200 plus cetrelimab in muscle-invasive bladder cancer not undergoing radical cystectomy is being discontinued.