Xagena.net - Update in Medicine

EMA has rejected the marketing authorization of the osteoporosis drug Evenity

The European Medicines Agency ( EMA ) has recommended the refusal of the marketing authorisation for Evenity, a medicine intended for the treatment of osteoporosis. Evenity was developed as a medic ... read article

FDA approves first treatment for chronic rhinosinusitis with nasal polyps: Dupixent

The FDA ( U.S. Food and Drug Administration ) has approved Dupixent ( Dupilumab ) to treat adults with nasal polyps accompanied by chronic rhinosinusitis ( prolonged inflammation of the sinuses and na ... 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

Long-term survival benefit for metastatic melanoma patients treated with Dabrafenib plus Trametinib

The results from COMBI-d and COMBI-v clinical trials were presented at the 2019 American Society of Clinical Oncology ( ASCO ) Annual Meeting and published simultaneously in The New England Journal of ... read article

Larotrectinib efficacy in patients with TRK fusion cancer and primary CNS tumors or brain metastases

A new analysis from clinical trials in patients with TRK fusion cancer and brain metastases or primary tumors of the central nervous system ( CNS ) has confirmed the strong activity of Larotrectinib ( ... 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

Pre-menopausal women with advanced breast cancer: adding Ribociclib to first-line endocrine therapy significantly improves survival

The randomized phase III MONALEESA-7 trial found that adding Ribociclib ( Kisqali ) to standard-of-care endocrine therapy has significantly improved overall survival for premenopausal women with advan ... 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

FDA has approved Cablivi, first therapy for the treatment of adult patients with a rare blood clotting disorder, acquired thrombotic thrombocytopenic purpura

The FDA ( U.S. Food and Drug Administration ) has approved Cablivi ( Caplacizumab-yhdp ) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive ... read article

Vizimpro as first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending Vizimpro ( Dacomitinib ), as monotherapy, for the first ... 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

EMA: Omega-3 fatty acid medicines no longer considered effective in preventing heart disease

EMA ( European Medicines Agency ) has concluded that Omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a myocardial infarct ... read article

FDA has approved Talzenna for gBRCAm HER2-negative locally advanced or metastatic breast cancer

The FDA ( Food and Drug Administration ) has approved Talzenna ( Talazoparib ), a poly (ADP-ribose) polymerase ( PARP ) inhibitor, for patients with deleterious or suspected deleterious germline BRCA- ... read article