Xagena.net - Update in Medicine

Zytiga: CHMP recommends to broaden indication to include the treatment of men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

The EMA’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended broadening the existing marketing authorisation for Zytiga ( Abiraterone acetate ) plus Prednisone / Prednisolone to i ... read article

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

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