Xagena.net - Update in Medicine

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

Cabometyx for the treatment of advanced renal cell carcinoma

The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cabometyx, intended for the ... read article

Kisplyx for the treatment of patients with unresectable advanced or metastatic renal cell carcinoma

The Committee for Medicinal Products for Human Use ( CHMP ) of EMA ( European Medicines Agency ) has adopted a positive opinion on Kisplyx for the treatment of patients with unresectable advanced or m ... read article

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

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

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

FDA: breakthrough therapy designation for Avelumab, a human anti-PD-L1 IgG1 monoclonal antibody, in metastatic Merkel cell carcinoma

The FDA ( Food and Drug Administration ) has granted Avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with m ... 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

Dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation

The FDA ( Food and Drug Administration ) has approved Dabrafenib ( Tafinlar capsule ), for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an ... read article

Patients with lung cancer who carry specific HER2 mutations may benefit from certain anti-HER2 drugs

New results from a retrospective study suggest that anti-HER2 treatments, like the widely used breast cancer agent Trastuzumab ( Herceptin ), have anti-cancer effects in a small subset of patients wit ... read article

2013 - DECISION Trial: Sorafenib improves progression-free survival in patients with radioactive iodine refractory differentiated thyroid cancer

Bayer HealthCare and Onyx Pharmaceuticals have announced that a phase III trial of Nexavar ( Sorafenib ) tablets in patients with locally advanced or metastatic radioactive iodine ( RAI )-refractory d ... read article

Afinitor for advanced breast cancer, FDA approved

The FDA ( Food and Drug Administration ) has approved Afinitor ( Everolimus ) for use in combination with Aromasin ( Exemestane ) to treat certain postmenopausal women with advanced hormone-receptor p ... read article

Ustekinumab ( Stelara ), an antibody proven to treat the skin condition psoriasis, has now shown positive results in decreasing the debilitating effects of Crohn’s Disease, according to researchers at ... read article

European Union: Votrient has received marketing authorisation in the treatment of certain advanced soft tissue sarcoma subtypes

European Commission has granted Votrient ( Pazopanib ) marketing authorisation for the treatment of patients with advanced soft tissue sarcoma ( aSTS ) who have received prior chemotherapy or have pro ... read article