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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

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

The combination of Sacubitril and Valsartan protects against cardiac rupture and improves survival after acute myocardial infarction in murine model

A study examined the effects of LCZ696 ( Sacubitril and Valsartan; Entresto ) on acute experimental myocardial infarction ( MI ) in mice and whether it has cardioprotective effects beyond renin-angiot ... read article

Nivolumab in glioblastoma multiforme, CheckMate -143 did not meet its primary endpoint of improved overall survival

CheckMate -143, a randomized phase 3 clinical trial evaluating the efficacy and safety of Nivolumab ( Opdivo ) in patients with first recurrence of glioblastoma multiforme ( GBM ), did not meet its pr ... read article

Androgen receptor-inhibitors: Enzalutamide improves metastasis-free survival in patients with non-metastatic castration-resistant prostate cancer

Parkinson's disease: Safinamide improves motor function, overall clinical status and health-related quality of life

Safinamide ( Xadago ) is an orally active, selective, reversible monoamine oxidase-B inhibitor with both dopaminergic and non-dopaminergic ( glutamatergic ) properties. In the European Union, Safi ... read article

Nivolumab in glioblastoma multiforme, CheckMate -143 did not meet its primary endpoint of improved overall survival

Focus

Multiple sclerosis: FDA has approved Tecfidera

The FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethyl fumarate ) capsules to treat adults with relapsing forms of multiple sclerosis.Multiple sclerosis is a chronic, inflammatory, ... read article

Apremilast linked to significant and clinically meaningful improvements for the primary and major secondary endpoint in plaque psoriasis

Celgene has announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving Apremilast 30 mg BID monotherapy in both the ESTEEM 1 and 2 phase ... read article

Kadcyla, a new treatment for late-stage breast cancer, approved by Food and Drug Administration

The U.S. Food and Drug Administration ) has approved Kadcyla ( Ado-Trastuzumab Emtansine ), a new therapy for patients with HER2-positive, late-stage ( metastatic ) breast cancer.HER2 is a protein inv ... read article

FISSION and NEUTRINO trial: Sofosbuvir has met primary endpoints for hepatitis C

Results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide Sofosbuvir in combination with Ribavirin ( FISSION ) and in combination with Ribavirin ... read article

FDA has approved Eliquis to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation

The FDA ( Food and Drug Administration ) has approved the anti-clotting drug Eliquis ( Apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots ( systemic embolism ) in p ... read article

Chronic hepatitis C: Promacta for patients with thrombocytopenia to allow the initiation and maintenance of Interferon-based therapy

GlaxoSmithKline ( GSK ) has announced that the FDA ( Food and Drug Administration ) has approved Promacta ( Eltrombopag; in Europe: Revolade ) for the treatment of thrombocytopenia in patients with ch ... read article

Bosulif for chronic myelogenous leukemia, approved by Food and Drug Administration

The FDA ( Food and Drug Administration ) has approved Bosulif ( Bosutinib ) to treat chronic myelogenous leukemia ( CML ), a blood and bone marrow disease that usually affects older adults.An estimate ... read article

Increased risk of high-grade prostate cancer with 5-alpha reductase inhibitors

Men aged 55 and over with a normal digital rectal examination and PSA less than or equal to 3.0 ng/mL at baseline taking Finasteride 5 mg/day ( 5 times the dose of Propecia ) in the 7-year Prostate Ca ... read article