Xagena.net - Update in Medicine

European Union: Keytruda, an anti-PD-1 therapy, approved for metastatic microsatellite instability-high colorectal cancer patients

The European Commission ( EC ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability ... read article

Keytruda approved by FDA for patients with TMB-high solid tumors

The FDA ( Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ) for the treatment of adults and pediatric patients with unresectable or metastatic tumor mutational burden-high ( TMB-H ... read article

KEYNOTE-355 trial: Pembrolizumab in combination with chemotherapy met primary endpoint of progression-free survival as first-line treatment for metastatic triple-negative breast cancer with expression of PD-L1

The pivotal phase 3 KEYNOTE-355 trial investigating Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free surviva ... read article

KEYNOTE-024 three-year survival update: Pembrolizumab effective as first-line therapy for advanced non-small-cell lung cancer

First line Pembrolizumab ( Keytruda ) monotherapy provides durable long-term overall survival benefit compared to chemotherapy, according to data presented at the IASLC 2019 World Conference on Lung C ... read article

Keytruda as monotherapy for patients with metastatic small cell lung cancer with disease progression on or after Platinum-based chemotherapy and at least one other prior line of therapy: FDA approved

The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as monotherapy for the treatment of patients with metastatic small cell lung cancer ( SCLC ... read article

Enfortumab vedotin, a novel targeted-antibody treatment has produced responses in nearly half of patients with advanced urothelial cancer

A single arm, phase II clinical trial of 125 patients has shown treatment with Enfortumab vedotin, an agent targeting nectin-4, a protein found in 97% of urothelial cancers, has produced responses in ... read article

Advanced non-small cell lung cancer: Pembrolizumab increases historic survival rate in patients with higher PD-L1 expression and chemotherapy-naive

Five-year data from the phase Ib KEYNOTE-001 clinical trial has shown that Pembrolizumab ( Keytruda ) was safe and effective and substantially increased overall survival for advanced non-small cell lu ... read article

Advanced gastroesophageal junction and gastric carcinoma: front-line Pembrolizumab is promising alternative to chemotherapy

The KEYNOTE-062 phase III randomized clinical trial has achieved its primary endpoint, showing that for patients with PD-L1-positive, HER2-negative, advanced gastric or gastroesophageal junction ( G/G ... read article

Keytruda in combination with Inlyta as first-line treatment for patients with advanced renal cell carcinoma, approved by FDA

The U.S. Food and Drug Administration ( FDA ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, in combination with Inlyta ( Axitinib ), a tyrosine kinase inhibitor, for the first-line tr ... read article

Keytruda for hepatocellular carcinoma, approved by FDA

The FDA ( Food and Drug Administration ) has granted accelerated approval to Keytruda ( Pembrolizumab ) for patients with hepatocellular carcinoma ( HCC ) who have been previously treated with Sorafen ... read article

Epacadostat in combination with Pembrolizumab in patients with unresectable or metastatic melanoma: ECHO-301/KEYNOTE-252 study stopped early for lack-of-benefit

An external Data Monitoring Committee ( eDMC ) review of the pivotal phase 3 ECHO-301/KEYNOTE-252 study results evaluating Epacadostat in combination with Pembrolizumab ( Keytruda ) in patients with u ... read article

KEYNOTE-189 trial: Pembrolizumab improves overall survival and progression-free survival as first-line treatment in combination with Pemetrexed and Platinum chemotherapy in metastatic nonsquamous non-small cell lung cancer

The pivotal phase 3 KEYNOTE-189 trial investigating Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, in combination with Pemetrexed ( Alimta ) and Cisplatin or Carboplatin, for the first-line treatme ... read article

FDA granted breakthrough therapy designation for Lenvatinib in combination with Pembrolizumab for patients with advanced and/or metastatic renal cell carcinoma

Multiple receptor tyrosine kinase inhibitor Lenvatinib ( Lenvima ) and anti–PD-1 therapy Pembrolizumab ( Keytruda ) as a combination therapy for patients with renal cell carcinoma received the designa ... read article

Keytruda for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations, recommended by CHMP for approval

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Keytruda ( Pembrolizumab ), an anti-PD-1 th ... read article

CHMP positive opinion for Keytruda for the treatment of advanced non-small cell lung cancer

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Keytruda ( Pembrolizumab ), the anti-PD-1 t ... read article