Xagena.net - Update in Medicine

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

Yescarta has received European marketing authorization for the treatment of relapsed or refractory diffuse large B-cell lymphom and primary mediastinal large B-cell lymphoma

The European Commission ( EC ) has granted Marketing Authorization for Yescarta ( Axicabtagene ciloleucel ) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma ... read article

Alecensa as a first-line treatment for people with ALK-positive advanced non-small cell lung cancer

The European Union’s ( EU ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending the approval of Alecensa ( Alectinib ) as a monotherapy for the first-li ... 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

CHMP grants positive opinion for Venetoclax tablets for patients with difficult-to-treat chronic lymphocytic leukaemia

The European Committee for Medicinal Products for Human Use ( CHMP ) has granted a positive opinion for Venclyxto ( Venetoclax ) tablets for the treatment of chronic lymphocytic leukaemia ( CLL ) in t ... read article

FDA has granted Breakthrough Therapy Designation for Alecensa for first-line treatment of people with ALK-positive non-small cell lung cancer

Alecensa ( Alectinib ), an ALK inhibitor, has received a second Breakthrough Therapy Designation ( BTD ) from the United States Food and Drug Administration ( FDA ). The latest BTD was granted for the ... read article

Opdivo has received Breakthrough Therapy Designation from FDA for advanced urothelial carcinoma

The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy Designation to Opdivo ( Nivolumab ) for the potential indication of unresectable locally advanced or metastatic urothelial car ... read article

European Commission: Revlimid approved for the treatment of relapsed / refractory patients with mantle cell lymphoma

The European Commission ( EC ) has approved Revlimid ( Lenalidomide ) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma ( MCL ). Mantle cell lymphoma is a rare su ... 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

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

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

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

Humira, approved in Europe for children and adolescents from four years of age with severe chronic plaque psoriasis

The European Commission ( EC ) has granted marketing authorization for Humira ( Adalimumab ) for the treatment of severe chronic plaque psoriasis in children and adolescents from four years of age who ... read article

ALK+ non-small cell lung cancer resistant to Crizotinib: AP26113 has received FDA Breakthrough Therapy designation

AP26113, has received Breakthrough Therapy designation by the FDA ( Food and Drug Administration ) for the treatment of patients with anaplastic lymphoma kinase positive ( ALK+ ) metastatic non-small ... read article

Nivolumab, a PD-1 immune checkpoint inhibitor, in non-small cell lung cancer

Nivolumab ( Opdivo ) is a PD-1 immune checkpoint inhibitor. The MAA submitted to the EMA ( European Medicine Agency ) in lung cancer is based on data from the phase 2 study ( Study-063 ) of Nivolumab ... read article