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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

Phase 1 trial evaluating MVT-5873 in combination with first-line chemotherapy in pancreatic cancer: promising early results

Interim results from the ongoing phase 1 trial evaluating MVT-5873 in combination with standard of care chemotherapy in patients newly diagnosed with pancreatic and other CA19-9 positive malignancies ... 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

FDA has approved Verzenio for HR+/HER2- advanced or metastatic breast cancers

The FDA ( Food and Drug Administration ) has approved Verzenio ( Abemaciclib ) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative ... 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

Zytiga: CHMP recommends to broaden indication to include the treatment of men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

The EMA’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended broadening the existing marketing authorisation for Zytiga ( Abiraterone acetate ) plus Prednisone / Prednisolone to i ... read article

EMA: new indication for Cabometyx for first-line treatment of advanced renal cell carcinoma in adults

The European Medicines Agency ( EMA ) has validated the application for variation to the Cabometyx ( Cabozantinib ) marketing authorization for the addition of a new indication in first-line treatment ... read article

EMA: new indication for Cabometyx for first-line treatment of advanced renal cell carcinoma in adults

FDA: Actemra for the treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy

The U.S. Food and Drug Administration ( FDA ) has approved Actemra ( Tocilizumab ) intravenous injection for the treatment of chimeric antigen receptor ( CAR ) T cell-induced severe or life-threatenin ... 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

Oxervate for the treatment of moderate or severe neurotrophic keratitis, a rare eye disease, approved in European Union

The European Commission ( EC ) has granted marketing authorisation for Oxervate ( Cenegermin ) for the treatment of moderate or severe neurotrophic keratitis, a rare eye disease that can lead to loss ... read article

Focus

New indication for Eylea in EU: treatment of visual impairment due to macular edema secondary to central retinal vein occlusion

Bayer HealthCare has announced that Eylea ( Aflibercept solution for injection ) has been approved by the European Commission ( EC ) for the treatment of visual impairment due to macular edema seconda ... read article

Ibrutinib shows efficacy as treatment for chronic lymphocytic leukemia and mantle cell lymphoma

Two clinical studies published in the New England Journal of Medicine ( NEJM ) suggest that the novel agent Ibrutinib shows real potential as a safe, effective, targeted treatment for adults with chro ... read article

Olmesartan Medoxomil can cause sprue-like enteropathy

FDA ( Food and Drug Administration ) has warned that the blood pressure drug Olmesartan Medoxomil ( marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics ) can cause intestinal problems know ... read article

Barrett's esophagus: Acetylsalicylic acid may fight cancer by slowing DNA damage

Aspirin ( Acetylsalicylic acid ) is known to lower risk for some cancers, and a new study led by a UC San Francisco researcher, Carlo Maley, points to a possible explanation, with the discovery that A ... read article

Metastatic or unresectable melanoma: FDA approves Tafinlar and Mekinist

The Food and Drug Administration ( FDA ) has approved two new drugs, Tafinlar ( Dabrafenib ) and Mekinist ( Trametinib ), for patients with advanced ( metastatic ) or unresectable melanoma, the most d ... read article

Giant cell tumor of the bone: FDA approves Xgeva

The Food and Drug Administration ( FDA ) has expanded the use of Xgeva ( Denosumab ) to treat adults and some adolescents with giant cell tumor of the bone ( GCTB ), a rare and usually non-cancerous t ... read article

Riociguat has demonstrated significant and sustained improvements in 6MWD and WHO functional class in patients with pulmonary arterial hypertension

Data from the interim analysis of the on-going PATENT-2 trial with Riociguat, the open-label long-term extension of the pivotal Phase III study PATENT-1, were presented at the American Thoracic Societ ... read article

Canagliflozin, a SGLT2 inhibitor, for the treatment of adults with type 2 diabetes

Janssen Pharmaceuticals has announced the FDA ( Food and Drug Administration ) has approved Invokana ( Canagliflozin ) for the treatment of adults with type 2 diabetes. Invokana is the first in a new ... read article