MedicineNews.net - Medical Updates

First two CAR-T cell medicines approved in the European Union: Kymriah and Yescarta

The European Commission ( EC ) has approved the first two marketing authorisations for chimeric antigen receptors ( CAR ) T-cells medicines in the European Union ( EU ). Kymriah ( Tisagenlecleucel ... read article

SOLAR-1 trial: alpha-specific PI3K inhibitor Alpelisib has met primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation

The global phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor Alpelisib ( BYL719 ) has met the primary endpoint showing an improvement in progression-free survival ( ... read article

TRANSITION trial: Entresto can be safely initiated shortly after an acute heart failure episode

Data from the TRANSITION study presented at the European Society of Cardiology ( ESC ) Congress in Munich, Germany, have shown that Entresto ( Sacubitril / Valsartan ) can be initiated early and safel ... read article

FDA has approved Rituxan for pemphigus vulgaris

The FDA ( U.S. Food and Drug Administration ) has approved Rituxan ( Rituximab ) for the treatment of adults with moderate to severe pemphigus vulgaris, a rare, serious, potentially life-threatening c ... read article

ARCTIC trial in third-line non-small cell lung cancer: Durvalumab monotherapy showed a clinically-meaningful reduction in the risk of death compared to chemotherapy

Results from the phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer ( NSCLC ) who have received at least two prior treatments, were announced. This rand ... read article

Pembrolizumab improves overall survival and progression-free survival as first-line treatment for squamous non-small cell lung cancer (NSCLC) in KEYNOTE-407 trial

The pivotal phase 3 KEYNOTE-407 trial investigating Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, in combination with Carboplatin-paclitaxel or nab-Paclitaxel, as first-line treatment for metastat ... read article

Tivozanib, a VEGF tyrosine kinase inhibitor, for the treatment of adult patients with advanced renal cell carcinoma

Tivozanib ( Fotivda ) is an oral, once-daily, vascular endothelial growth factor ( VEGF ) tyrosine kinase inhibitor ( TKI ) for the treatment of adult patients with advanced renal cell carcinoma ( RCC ... read article

Symdeko to treat the underlying cause of cystic fibrosis in people ages 12 and older with certain mutations in the CFTR gene: FDA approved

The U.S. Food and Drug Administration ( FDA ) has approved Symdeko ( Tezacaftor / Ivacaftor and Ivacaftor ) for treating the underlying cause of cystic fibrosis in people ages 12 and older who have tw ... read article

Tymlos for the treatment of postmenopausal women with osteoporosis at high risk for fracture

The FDA ( US Food and Drug Administration ) has approved Tymlos ( Abaloparatide ) injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of ... read article

HER2-positive breast cancer: Neratinib, little benefit and severe toxicity

The FDA ( U.S. Food and Drug Administration ) has approved 1 year of extended adjuvant Neratinib ( Nerlynx ) after chemotherapy and a year of Trastuzumab ( Herceptin ) for HER2-positive breast cancer ... read article

KEYNOTE-061, Pembrolizumab does not meet primary endpoint of overall survival in previously treated patients with gastric or gastroesophageal junction adenocarcinoma

The pivotal phase 3 KEYNOTE-061 trial investigating Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, as a second-line treatment for patients with advanced gastric or gastroesophageal junction ( GEJ ) ... read article

Mvasi, a biosimilar to the cancer drug Avastin, approved from FDA for certain colorectal, lung, brain, kidney and cervical cancers

The FDA ( Food and Drug Administration ) has approved Mvasi ( Bevacizumab-awwb ) as a biosimilar to Avastin ( Bevacizumab ) for the treatment of multiple types of cancer. Mvasi is the first biosimil ... read article

Update on European application for Keytruda in combination with Pemetrexed and Carboplatin for first-line treatment of nonsquamous non-small cell lung cancer

Merck ( MSD ) has withdrawn its European application for Keytruda ( Pembrolizumab ) in combination with Pemetrexed and Carboplatin as a first-line treatment for metastatic nonsquamous non-small cell l ... read article

Apixaban associated with lower risk of stroke and lower rates of major bleeding compared to Warfarin

The findings from a real-world data analysis of the U.S. Humana database, in which treatment with Apixaban ( Eliquis ) was associated with a significantly lower risk of stroke / systemic embolism and ... read article

Positive results from PROSPER trial of Enzalutamide in patients with non-metastatic castration-resistant prostate cancer

The phase 3 PROSPER trial evaluating Enzalutamide ( Xtandi ) plus androgen deprivation therapy ( ADT ) versus ADT alone in patients with non-metastatic ( M0 ) castration-resistant prostate cancer ( CR ... read article