Global

Sacituzumab govitecan-hziy significantly improved overall response rate in Chinese patients with metastatic triple-negative breast cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of sotorasib for the treatment of adult patients with advanced non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have progressed after at least 1 prior line of systemic therapy.

The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

Health Canada has approved infigratinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement.

The investigational next-generation ROS1/NTRK inhibitor taletrectinib was found to elicit encouraging responses with an acceptable toxicity profile in patients with ROS1-positive non–small cell lung cancer, according to preliminary data from the phase 2 TRUST trial.

Fam-trastuzumab deruxtecan-nxki as a second-line treatment elicited a 38% confirmed objective response rate in Western patients with HER2-positive gastric/gastroesophageal junction cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion of pembrolizumab plus chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pralsetinib for use as a single agent in adult patients with RET fusion–positive advanced non–small cell lung cancer who did not receive prior RET inhibition.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab plus fluoropyrimidine and platinum-containing chemotherapy as frontline treatment for adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma with a PD-L1 combined positive score of 5 or higher.

Melphalan flufenamide (melflufen) plus dexamethasone demonstrated an improvement in progression-free survival vs pomalidomide/dexamethasone in patients with transplant-naïve relapsed/refractory multiple myeloma.

The combination of ado-trastuzumab emtansine and osimertinib demonstrated minimal antitumor effects on patients with EGFR-mutated non–small cell lung cancer, according to interim data of the phase 2 TRAEMOS trial.

The National Medical Products Administration in China has approved pembrolizumab for use in combination with platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or gastroesophageal junction cancer.

The European Association of Neuro-Oncology and ESMO have released clinical practice guidelines, which provide management recommendations for the diagnosis, treatment, and follow-up of patients with solid tumor brain metastases.

ADP-A2AFPspecific peptide enhanced affinity receptor T cells were associated with an acceptable safety profile and elicited antitumor activity in patients with advanced hepatocellular carcinoma.

David J. Pinato, MD, discusses combination strategies in HCC, how to manage associated toxicities, and how safety profiles can help to inform treatment decisions for this patient population.

Arndt Vogel, MD, discusses the utility of frontline lenvatinib or sorafenib in hepatocellular carcinoma.

Nicole Rich, MD, discusses the prevalence of cachexia in hepatocellular carcinoma.

The European Commission has granted an expanded approval to ravulizumab-cwvz to include children with a body weight of at least 10 kg, as well as adolescents, with paroxysmal nocturnal hemoglobinuria.

The Japanese Ministry of Health, Labor, and Welfare has approved the combination of cabozantinib and nivolumab for the treatment of patients with unresectable or metastatic renal cell carcinoma.

The European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy as frontline options for adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The United Kingdom’s National Institute for Health and Care Excellence has issued draft guidance supporting the use of abemaciclib in the treatment of adult patients with metastatic hormone receptor–positive/HER2-negative breast cancer.

Many checkpoint inhibitors are currently under investigation in combination with concurrent radiotherapy in stage III non–small cell lung cancer, which experts propose could have practice-changing implications.

The European Commission has approved nivolumab for use as an adjuvant treatment in adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after neoadjuvant chemoradiation.

Roche Registration GmbH has withdrawn its application to extend the use of atezolizumab to the treatment of patients with early or locally advanced triple-negative breast cancer in Europe.

Avapritinib demonstrated encouraging clinical activity in Chinese patients with PDGFRA D842V–mutant gastrointestinal stromal in a bridging study of the NAVIGATOR trial.

The optimal sequence of therapies in the second- or later-line settings for patients with hepatocellular carcinoma remains unclear.

Lenvatinib demonstrated superiority to sorafenib in the first-line setting for patients with unresectable hepatocellular carcinoma, according to results of a propensity score matching analysis.

The European Commission has approved the combination of nivolumab plus ipilimumab for use in adult patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following previous fluoropyrimidine-based combination chemotherapy.