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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Merck ( MSD ) has withdrawn its European application for Keytruda ( Pembrolizumab ) in combination with Pemetrexed and Carboplatin as a first-line treatment for metastatic nonsquamous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

Advanced BRCA-related breast cancer: Olaparib, a PARP inhibitor, is superior to chemotherapy

During the American Society of Clinical Oncology ( ASCO ) Annual Meeting, the results of the phase III OlympiAD trial demonstrating for the first time that Olaparib ( Lynparza ) is superior to chemoth ... read article

Relapsing multiple sclerosis: oral Ozanimod has shown improvements compared to Interferon beta-1a for the primary endpoint of annualized relapse rate

SUNBEAM trial, evaluating the efficacy and safety of O)zanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis ( RMS ), met the primar ... read article

Actemra is the first FDA-approved treatment for adults with giant cell arteritis

The U.S. Food and Drug Administration ( FDA ) has approved Actemra [ European Union: RoActemra ] ( Tocilizumab ) subcutaneous injection for the treatment of giant cell arteritis ( GCA ), a chronic and ... read article

uniQure will not seek marketing authorization renewal for Glybera in European Union

uniQure has announced that it will not pursue the renewal of the Glybera ( Alipogene tiparvovec ) marketing authorization in Europe when it is scheduled to expire on October 25, 2017. According to ... read article

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

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

Castration-resistant prostate cancer: Cabozantinib linked to high rates of complete or partial bone scan resolution, pain relief, improvements in hemoglobin, and tumor regression

Exelixis has reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer ( CRPC ) treated with Cabozantinib ( XL184; Cometriq ) in an ongoing phase 2 ... read article