Xagena.net - Update in Medicine

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

KEYNOTE-189 trial: Pembrolizumab improves overall survival and progression-free survival as first-line treatment in combination with Pemetrexed and Platinum chemotherapy in metastatic nonsquamous non-small cell lung cancer

The pivotal phase 3 KEYNOTE-189 trial investigating Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, in combination with Pemetrexed ( Alimta ) and Cisplatin or Carboplatin, for the first-line treatme ... read article

FDA granted breakthrough therapy designation for Lenvatinib in combination with Pembrolizumab for patients with advanced and/or metastatic renal cell carcinoma

Multiple receptor tyrosine kinase inhibitor Lenvatinib ( Lenvima ) and anti–PD-1 therapy Pembrolizumab ( Keytruda ) as a combination therapy for patients with renal cell carcinoma received the designa ... read article

IMpower150 study: Atezolizumab and Bevacizumab plus chemotherapy reduce the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer

The phase III IMpower150 study met its co-primary endpoint of progression-free survival ( PFS ) and demonstrated that the combination of Atezolizumab ( Tecentriq ) and Bevacizumab ( Avastin ) plus c ... 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

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

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

Keytruda for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations, recommended by CHMP for approval

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Keytruda ( Pembrolizumab ), an anti-PD-1 th ... read article

Tecentriq for the treatment of patients with metastatic non-small cell lung cancer whose disease progressed during or following Platinum-containing chemotherapy, approved by FDA

The FDA ( Food and Drug Administration ) ha approved Atezolizumab ( Tecentriq ) for the treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) whose disease progressed during or fo ... 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

Avastin in combination with Tarceva for patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer with EGFR-activating mutations, EC approved

The European Commission ( EC ) has approved the use of Avastin ( Bevacizumab ) in combination with Tarceva ( Erlotinib ) for the first-line treatment of adult patients with unresectable advanced, meta ... read article