Xagena.net - Update in Medicine

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

FDA has approved twice-daily Xarelto 2.5-mg dose to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease

The U.S. Food and Drug Administration ( FDA ) has approved Xarelto ( Rivaroxaban ) to reduce the risk of major cardiovascular events, such as cardiovascular death, myocardial infarction and stroke, in ... read article

Lorbrena for previously-treated ALK-positive metastatic non-small cell lung cancer, approved from FDA

The FDA ( U.S. Food and Drug Administration ) has approved Lorbrena ( Lorlatinib ), a third-generation anaplastic lymphoma kinase ( ALK ) tyrosine kinase inhibitor ( TKI ) for patients with ALK-posit ... read article

Vizimpro for the first-line treatment of patients with EGFR-mutated metastatic non-small cell lung cancer, approved from FDA

The FDA ( U.S. Food and Drug Administration ) has approved Vizimpro ( Dacomitinib ), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) w ... read article

SOLO-1 trial: Olaparib maintenance therapy cut risk of disease progression or death by 70% in patients with newly-diagnosed, advanced BRCA-mutated ovarian cancer

The results from the phase III SOLO-1 trial testing Olaparib ( Lynparza ) tablets as a maintenance treatment for patients with newly-diagnosed, advanced BRCA-mutated ( BRCAm ) ovarian cancer who were ... read article

Locally-advanced, unresectable non-small cell lung cancer: approved Imfinzi in European Union

The European Commission has granted marketing authorisation for Imfinzi ( Durvalumab ) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer ( NSCLC ) in adults ... read article

FDA: Breakthrough Therapy Designation for LOXO-292, a selective RET inhibitor

The FDA ( U.S. Food and Drug Administration ) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for: the treatment of patients with metastatic RET-fusion-positive no ... read article

Target therapy: RG6042, an antisense oligonucleotide, for treatment of Huntington’s disease

The European Medicines Agency ( EMA ) has granted PRIME ( PRIority MEdicines ) designation for an investigational medicine RG6042 ( formerly known as IONIS-HTTRx ) for the treatment of people with Hun ... read article

Imbruvica plus Rituximab approved by FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia

The U.S. Food and Drug Administration ( FDA ) has approved Imbruvica ( Ibrutinib ) plus Rituximab ( Rituxan ) for the treatment of adult patients with Waldenström's macroglobulinemia ( WM ), a rare an ... read article