Xagena.net - Update in Medicine

FDA has approved Cabometyx tablets for patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy

The U.S. Food and Drug Administration ( FDA ) has approved Cabometyx ( Cabozantinib ) tablets for the treatment of patients with advanced renal cell carcinoma ( RCC ) who have received prior anti-angi ... read article

Epclusa for the treatment of all genotypes of chronic hepatitis C, CHMP has adopted positive opinion

The Committee for Medicinal Products for Human Use ( CHMP ), of the European Medicines Agency ( EMA ), has adopted a positive opinion for Epclusa, an investigational, pan-genotypic, once-daily tablet ... read article

Selumetinib for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer

The FDA ( Food and Drug Administration ) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, Selumetinib for adjuvant treatment of patients with stage III or IV differentiat ... read article

Zepatier for the treatment of chronic hepatitis C virus in adult patients, positive opinion from CHMP

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Zepatier ( Elbasvir and Grazoprevir ), an i ... read article

Positive CHMP opinion to extend indication of Kyprolis for the treatment of relapsed multiple myeloma

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion to extend the current indication for Kyprolis ( Carfilzomib ) to inc ... read article

FDA: Breakthrough Therapy Designation for Keytruda in classical Hodgkin lymphoma

The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy designation to Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, for the treatment of patients with relapsed or refractory cla ... read article

FDA grants priority review for Atezolizumab, a cancer immunotherapy, in locally advanced or metastatic non-small cell lung cancer whose disease expresses the protein PD-L1

The FDA ( Food and Drug Administration ) has accepted the Biologics License Application ( BLA ) and granted Priority Review for Atezolizumab ( anti-PDL1; MPDL3280A ) for the treatment of people with l ... read article

Nivolumab for the treatment of patients with classical Hodgkin lymphoma

Bristol-Myers Squibb is seeking to extend the current indications for Opdivo ( Nivolumab ) to include the treatment of patients with classical Hodgkin lymphoma ( cHL ) after prior therapies. The ap ... read article

Cancer immunotherapy: FDA grants priority review for Atezolizumab in locally advanced or metastatic non-small cell lung cancer

The FDA ( Food and Drug Administration ) has accepted the Biologics License Application ( BLA ) and granted Priority Review for Atezolizumab ( anti-PDL1; MPDL3280A ) for the treatment of people with l ... read article

LEADER trial: Liraglutide significantly reduces the risk of major adverse cardiovascular events

The results from the LEADER trial, which investigated the cardiovascular safety of Liraglutide ( Victoza ) over a period of up to 5 years in more than 9,000 adults with type 2 diabetes mellitus at hig ... read article

Label variation for Adcetris - Retreatment of adult patients with relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma, European Commission approved

The European Commission ( EC ) has approved a Type II variation for Adcetris ( Brentuximab vedotin ) to include data on the retreatment of adult patients with relapsed or refractory ( R/R ) Hodgkin ly ... read article

Patients with history of myocardial infarction: Brilique approved in European Union for extended treatment beyond the first year

The European Commission has granted marketing authorisation for Brilique ( Ticagrelor ) at a new 60mg dose for the treatment of patients who have suffered a myocardial infarction at least one year pri ... read article

Treatment of patients with untreated acute myeloid leukemia who are ineligible to receive standard induction therapy: Venetoclax receives Breakthrough Therapy designation from FDA

The Food and Drug Administration ( FDA ) has granted Breakthrough Therapy designation for the investigational agent Venetoclax in combination with hypomethylating agents ( HMAs ) for the treatment of ... read article

FDA has granted Breakthrough Therapy designation to Durvalumab for treatment of patients with PD-L1 positive urothelial bladder cancer

The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy designation ( BTD ) for Durvalumab ( MEDI4736 ), an investigational human monoclonal antibody directed against programmed dea ... read article

Treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer: Lynparza granted Breakthrough Therapy designation by FDA

The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy designation ( BTD ) for the oral poly ADP-ribose polymerase ( PARP ) inhibitor Lynparza ( Olaparib ), for the monotherapy trea ... read article