OncLive Global

The OncLive® Global Oncology condition center page is a comprehensive resource for clinical news and international expert insights on treatment of patients with cancer. This page features articles focused on ex-US regulatory news, interviews in written and video format, and podcasts that focus on unmet needs, treatment advances, and ongoing global research in oncology care.

Pembrolizumab/Lenvatinib Approved in Europe for Frontline RCC

November 29th 2021

The European Commission has approved the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced renal cell carcinoma.

European Commission Approves Pembrolizumab/Lenvatinib for Advanced or Recurrent Endometrial Cancer

November 29th 2021

The European Commission has granted an approval to the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior platinum-containing therapy in any setting and who are not eligible for curative surgery or radiation.

Sacituzumab Govitecan Approved in Europe for Second-Line Metastatic TNBC

November 23rd 2021

The European Commission granted marketing authorization for sacituzumab govitecan-hziy for use as a monotherapy in the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have previously received 2 or more systemic therapies, at least 1 of them for advanced disease.

Pralsetinib Approved in Europe for RET Fusion+ Advanced NSCLC

November 19th 2021

The European Commission has granted a conditional marketing authorization to pralsetinib for use as a single agent in adult patient with RET fusion–positive advanced non–small cell lung cancer who did not previously receive a RET inhibitor.

Sacituzumab Govitecan Meets ORR End Point in Chinese Patients With Metastatic TNBC

November 17th 2021

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

Sotorasib Approaches EU Approval for KRAS G12C–Mutated Advanced NSCLC

November 12th 2021

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.

Pembrolizumab/Chemo Approved in Europe for Select Locally Recurrent Unresectable or Metastatic TNBC

October 22nd 2021

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.

Nivolumab/Chemo Approved in Europe for HER2– Advanced or Metastatic Gastric, GEJ, or Esophageal Adenocarcinoma

October 21st 2021

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.

Relatlimab/Nivolumab Application for Frontline Advanced Melanoma Validated by EMA

October 1st 2021

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.

Infigratinib Approved in Canada for FGFR2+ Cholangiocarcinoma

September 29th 2021

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.

Taletrectinib Elicits Encouraging Responses in Crizotinib-Pretreated ROS1+ NSCLC

September 28th 2021

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.

Trastuzumab Deruxtecan Elicits Encouraging Activity in Western Patients With HER2+ Gastric/GEJ Cancer

September 17th 2021

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.

Pembrolizumab/Chemo Nears EU Approval for Select TNBC With PD-L1 CPS ≥10

September 17th 2021

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.

EU Panel Recommends Pralsetinib for RET Fusion+ Advanced NSCLC

September 17th 2021

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.

Nivolumab/Chemo Approaches EU Approval for Select HER2– Advanced or Metastatic Gastric, GEJ, or Esophageal Adenocarcinoma

September 17th 2021

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.

Melflufen/Dexamethasone Improves PFS in Transplant-Naïve Relapsed/Refractory Multiple Myeloma

September 12th 2021

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

TDM-1/Osimertinib Combo Has Limited Efficacy for Resistant EGFR+ NSCLC

September 8th 2021

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.

Pembrolizumab Approved in China for Frontline Advanced Esophageal or GEJ Cancer

September 7th 2021

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.

ESMO Publishes Guidelines for the Management of Solid Tumor Brain Metastases

September 7th 2021

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-A2AFP SPEAR T Cells Demonstrate Efficacy, Tolerability in Advanced HCC

September 7th 2021

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.