Xagena.net - Update in Medicine

EMA: new indication for Cabometyx for first-line treatment of advanced renal cell carcinoma in adults

The European Medicines Agency ( EMA ) has validated the application for variation to the Cabometyx ( Cabozantinib ) marketing authorization for the addition of a new indication in first-line treatment ... read article

FDA: Actemra for the treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy

The U.S. Food and Drug Administration ( FDA ) has approved Actemra ( Tocilizumab ) intravenous injection for the treatment of chimeric antigen receptor ( CAR ) T cell-induced severe or life-threatenin ... read article

MYSTIC trial in stage IV lung cancer: Durvalumab plus Tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy

Progression-free survival ( PFS ) results for the phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Durvalumab ( Imfinzi ) monotherapy or Durvalumab in combination with T ... read article

Oxervate for the treatment of moderate or severe neurotrophic keratitis, a rare eye disease, approved in European Union

The European Commission ( EC ) has granted marketing authorisation for Oxervate ( Cenegermin ) for the treatment of moderate or severe neurotrophic keratitis, a rare eye disease that can lead to loss ... read article

European CHMP adopts positive opinion for Vosevi, a single tablet regimen of Sofosbuvir, Velpatasvir, Voxilaprevir, for the treatment of all chronic hepatitis C genotypes

The Committee for Medicinal Products for Human Use ( CHMP ), the scientific committee of the European Medicines Agency ( EMA ), has adopted a positive opinion on Vosevi, an investigational, once-dail ... read article

Tagrisso receives full approval in the EU for patients with locally-advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer

The European Commission ( EC ) has granted full marketing authorisation for Tagrisso ( Osimertinib ) 40mg and 80mg once-daily tablets for the treatment of adult patients with locally-advanced or metas ... read article

Atezolizumab in people with previously treated advanced bladder cancer: IMvigor211 study did not meet its primary endpoint of overall survival compared to chemotherapy

The phase III IMvigor211 study, that evaluated Atezolizumab ( Tecentriq ) in people with locally advanced or metastatic urothelial cancer ( mUC ) whose disease progressed during or after treatment wit ... read article

Locally advanced or metastatic urothelial carcinoma: Imfinzi in patients with disease progression during or following Platinum-containing chemotherapy

The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Durvalumab ( Imfinzi ) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have ... read article

FDA: increased risk of serious pancreatitis with irritable bowel drug Viberzi in patients without a gallbladder

The FDA ( U.S. Food and Drug Administration ) is warning that Viberzi ( Eluxadoline ), a medicine used to treat irritable bowel syndrome with diarrhea ( IBS-D ), should not be used in patients who do ... read article

Ocrevus, the first drug for primary progressive multiple sclerosis approved by FDA

The FDA ( U.S. Food and Drug Administration ) has approved Ocrevus ( Ocrelizumab ) to treat adult patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis ( PPMS ... read article

CDK4/6 inhibitors: Kisqali in combination with an aromatase inhibitor as treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer

The U.S. Food and Drug Administration ( FDA ) has approved Kisqali ( Ribociclib ), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therap ... read article

Positive CHMP opinion for Tafinlar in combination with Mekinist in BRAF-positive non-small cell lung cancer patients

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Tafinlar ( Dabrafenib ) in combination with ... read article

Evolocumab has significantly reduced the risk of cardiovascular events in FOURIER Outcomes Study

The FOURIER trial to evaluate whether Evolocumab ( Repatha ) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease ( ASCVD ) met its prim ... read article

COMPASS trial: Rivaroxaban in patients with coronary or peripheral artery disease has shown overwhelming efficacy and has met primary endpoint early

The phase III trial COMPASS evaluating the efficacy and safety of Rivaroxaban ( Xarelto ) for the prevention of major adverse cardiac events ( MACE ) including cardiovascular death, myocardial infarct ... read article

Afstyla is the first and only single-chain therapy for haemophilia A, approved by European Commission

The European Commission has granted marketing authorisation for Afstyla [ recombinant human coagulation Factor VIII, single chain ] for children and adults with haemophilia A. Afstyla is the first a ... read article