Xagena.net - Update in Medicine

FDA has approved Cablivi, first therapy for the treatment of adult patients with a rare blood clotting disorder, acquired thrombotic thrombocytopenic purpura

The FDA ( U.S. Food and Drug Administration ) has approved Cablivi ( Caplacizumab-yhdp ) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive ... read article

Vizimpro as first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending Vizimpro ( Dacomitinib ), as monotherapy, for the first ... read article

FDA has approved Talzenna for gBRCAm HER2-negative locally advanced or metastatic breast cancer

The FDA ( Food and Drug Administration ) has approved Talzenna ( Talazoparib ), a poly (ADP-ribose) polymerase ( PARP ) inhibitor, for patients with deleterious or suspected deleterious germline BRCA- ... read article

Lorbrena for previously-treated ALK-positive metastatic non-small cell lung cancer, approved from FDA

The FDA ( U.S. Food and Drug Administration ) has approved Lorbrena ( Lorlatinib ), a third-generation anaplastic lymphoma kinase ( ALK ) tyrosine kinase inhibitor ( TKI ) for patients with ALK-posit ... read article

Vizimpro for the first-line treatment of patients with EGFR-mutated metastatic non-small cell lung cancer, approved from FDA

The FDA ( U.S. Food and Drug Administration ) has approved Vizimpro ( Dacomitinib ), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) w ... read article

SOLO-1 trial: Olaparib maintenance therapy cut risk of disease progression or death by 70% in patients with newly-diagnosed, advanced BRCA-mutated ovarian cancer

The results from the phase III SOLO-1 trial testing Olaparib ( Lynparza ) tablets as a maintenance treatment for patients with newly-diagnosed, advanced BRCA-mutated ( BRCAm ) ovarian cancer who were ... read article

Locally-advanced, unresectable non-small cell lung cancer: approved Imfinzi in European Union

The European Commission has granted marketing authorisation for Imfinzi ( Durvalumab ) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer ( NSCLC ) in adults ... read article

FDA: Breakthrough Therapy Designation for LOXO-292, a selective RET inhibitor

The FDA ( U.S. Food and Drug Administration ) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for: the treatment of patients with metastatic RET-fusion-positive no ... 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

Ovarian cancer: Olaparib significantly delays disease progression in 1st-line SOLO-1 trial

Olaparib ( Lynparza ) met primary endpoint of progression-free survival in women with BRCA-mutated advanced ovarian cancer and showed a safety profile in SOLO-1 trial consistent with previous trials. ... read article

Durvalumab improves overall survival in PACIFIC trial for unresectable stage III non-small cell lung cancer

Positive overall survival ( OS ) results for the phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Durvalumab ( Imfinzi ) in patients with unresectable s ... read article

FDA has approved Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer

The US Food and Drug Administration ( FDA ) has approved Tagrisso ( Osimertinib ) for the 1st-line treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) whose tumours have epiderm ... read article

Epacadostat in combination with Pembrolizumab in patients with unresectable or metastatic melanoma: ECHO-301/KEYNOTE-252 study stopped early for lack-of-benefit

An external Data Monitoring Committee ( eDMC ) review of the pivotal phase 3 ECHO-301/KEYNOTE-252 study results evaluating Epacadostat in combination with Pembrolizumab ( Keytruda ) in patients with u ... read article

IMpower131 trial: Atezolizumab plus chemotherapy reduces the risk of disease worsening or death in the initial treatment of people with advanced squamous non-small cell lung cancer

IMpower131 study met its co-primary endpoint of progression-free survival and demonstrated that the combination of Atezolizumab ( Tecentriq ) plus chemotherapy ( Carboplatin and Abraxane [ albumin-bou ... read article

CheckMate -227 trial: superior progression-free survival with Nivolumab plus Ipilimumab combination versus chemotherapy in first-line non-small cell lung cancer patients with high tumor mutation burden

The ongoing phase 3 CheckMate -227 study met its co-primary endpoint of progression-free survival ( PFS ) with the Opdivo ( Nivolumab ) plus Yervoy ( Ipilimumab ) combination versus chemotherapy in fi ... read article