Chris Ryan

BDC-1001 monotherapy and in combination with nivolumab generated antitumor activity with acceptable tolerability in patients with advanced HER2-expressing solid tumors, according to topline data from the dose-escalation portion of a phase 1 trial.

The FDA has granted a fast track designation to RRx-001 for the prevention and attenuation of severe oral mucositis associated with chemotherapy and radiation in patients with head and neck cancer.

Up-front treatment with osimertinib reduced the risk of brain progression-free survival but provided a comparable overall survival benefit compared with sequential treatment with gefitinib followed by osimertinib in patients with advanced non–small cell lung cancer harboring EGFR mutations.

Canada Health has approved the fixed-duration, all-oral combination of ibrutinib and venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia, including those with 17p deletion.

Japan’s Ministry of Health, Labor and Welfare has approved fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.

The combination of toripalimab, bevacizumab, and platinum-based chemotherapy elicited responses in patients with refractory, recurrent or metastatic cervical cancer.

Iovance Biotherapeutics has submitted a rolling biologics license application to the FDA seeking the approval of the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced unresectable or metastatic melanoma who progressed on or after prior anti–PD-1/L1 therapy and targeted therapy.

The addition of zolbetuximab to CAPOX led to a statistically significant improvement in progression-free survival and overall survival compared with placebo plus CAPOX for patients with Claudin-18.2–positive/HER2-negative, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Axicabtagene ciloleucel produced a statistically significant improvement in overall survival compared with standard-of-caretherapy in patients with relapsed/refractory large B-cell lymphoma, according to data from the ZUMA-7 trial.

The FDA has granted an orphan drug designation to FORE8394 for the treatment of primary brain and central nervous system malignancies.

VTP-200 generated immunogenic responses and tolerability in patients with human papillomavirus–positive cervical lesions.

Patritumab deruxtecan elicited responses in previously treated patients with EGFR-mutated metastatic or unresectable non–small cell lung cancer and patients with HER3-expressing metastatic breast cancer.

The combination of JTX-8064 and pimivalimab generated deep and durable responses in patients with third- or fourth-line platinum-resistant ovarian cancer.

A coformulation of pembrolizumab and vibostolimab did not elicit a statistically significant improvement in progression-free survival vs docetaxel in pretreated patients with metastatic non–small cell lung cancer.

The FDA has approved dabrafenib with trametinib for the treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.

The FDA has approved a supplementary new drug application for Illuccix for use in the selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan is indicated.

Avasopasem manganese provided an overall clinical benefit vs placebo in reducing the burden of severe oral mucositis in patients with locally advanced head and neck cancer, according to a post-hoc generalized pairwise comparison analysis of the phase 3 ROMAN trial.

Ripretinib has been added to the National Comprehensive Cancer Network Guidelines as a preferred regimen in the second-line treatment of patients with gastrointestinal stromal tumor who are intolerant to sunitinib.

Vorasidenib monotherapy elicited a statistically significant and clinically meaningful improvement in progression-free survival compared with placebo in patients with residual or recurrent IDH1/2-mutant low-grade glioma.

Although the immune system plays a vital role in attacking tumor cells, the immune mechanisms vary from tumor to tumor, and factors in the tumor microenvironment can reduce the effectiveness of the body’s immune response.

The FDA has placed a clinical hold on a phase 1 trial investigating the antibody-drug conjugate XMT-2056 for the treatment of patients with advanced/recurrent solid tumors that express HER2.

Soligenix has submitted a Type A meeting request to the FDA to discuss the contents of a refusal to file letter from the regulatory agency regarding the new drug application for synthetic hypericin for the treatment of early-stage cutaneous T-cell lymphoma.

First-line treatment with the combination of pembrolizumab and chemotherapy generated a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone in patients with unresectable advanced or metastatic malignant pleural mesothelioma.

Osimertinib produced a statistically significant and clinically meaningful improvement in overall survival compared with placebo as adjuvant treatment for patients with stage IB, II, or IIIA, EGFR-mutated non–small cell lung cancer after complete tumor resection with curative intent.

The progression-free survival benefit associated with the combination of nivolumab plus cabozantinib compared with sunitinib was largely independent of PD-L1 and c-MET status in previously untreated patients with advanced or metastatic renal cell carcinoma.

The FDA has granted a fast track designation to the novel aryl hydrocarbon receptor antagonist IK-175 in combination with nivolumab for the treatment of patients with advanced urothelial carcinoma who have progressed on or within 3 months of receiving the last dose of checkpoint inhibitors.

The FDA’s Office of Therapeutic Products has accepted a resubmission of the biologics license application (BLA) for remestemcel-L for the treatment of pediatric patients with steroid-refractory, acute graft-vs-host-disease.

The FDA has approved the VENTANA PD-L1 assay for expanded use in patients with advanced non–small cell lung cancer to help identify patients who may be candidates for treatment with cemiplimab.

The European Commission has granted a full marketing authorization to luspatercept-aamt for use in adult patients with anemia associated with non–transfusion-dependent β-thalassemia.

The phase 3 LIMBER-304 trial evaluating parsaclisib plus ruxolitinib in patients with myelofibrosis will be discontinued after results of a preplanned interim analysis indicated that the study is unlikely to meet its primary end point of targeted reduction in spleen volume in the intent-to-treat population.