Global Oncology

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.

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.

The European Commission has approved pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction adenocarcinoma whose tumors have PD-L1 expression.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after previous neoadjuvant chemoradiotherapy.

The Chinese National Medical Products Administration has granted conditional approval to olaparib for use as a monotherapy in the treatment in adult patients with germline or somatic BRCA-mutated, metastatic castration-resistant prostate cancer who have progressed after previous treatment that included a new hormonal agent like abiraterone acetate or enzalutamide.

The European Commission has granted marketing authorization for the expanded use of subcutaneous daratumumab for use in 2 new indications.

The European Commission has granted a conditional approval to selumetinib for the treatment of pediatric patients with symptomatic, inoperable plexiform neurofibromas and neurofibromatosis type 1 who are at least 3 years of age.

The China National Medical Products Administration has granted a conditional approval to zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia who have previously received at least 1 therapy.

The National Medical Products Administration of China has approved surufatinib for the treatment of patients with advanced pancreatic neuroendocrine tumors.

The European Commission has granted full marketing authorization to azacitidine tablets for use as a maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission or CR with incomplete blood recovery after induction therapy with or without consolidation treatment, and who are not eligible for, or do not choose to proceed to, hematopoietic stem cell transplant.

The Japan Ministry of Health, Labour, and Welfare has granted conditional and time-limited approval to teserpaturev for the treatment of patients with malignant glioma; this is the first oncolytic virus to receive approval for use in this indication or any primary brain cancer.