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Venclyxto in combination with Gazyvaro for patients with previously-untreated chronic lymphocytic leukemia, approved in European Union

The European Commission ( EC ) has approved Venclyxto ( Venetoclax ) in combination with Gazyvaro ( Obinutuzumab ) for the treatment of adult patients with chronic lymphocytic leukemia ( CLL ) who wer ... read article

CheckMate -025 trial: 26% of patients treated with Nivolumab are alive at five years in previously treated advanced or metastatic renal cell carcinoma

Five-year follow-up results from the phase 3 CheckMate -025 study continue to demonstrate that treatment with Nivolumab ( Opdivo ) delivers superior overall survival ( OS ) and objective response rate ... read article

FDA has required the withdrawal of the weight-loss drug Belviq from the market: potential risk of cancer outweighs the benefits

The FDA ( U.S. Food and Drug Administration ) has requested that the manufacturer of Belviq, Belviq XR ( Lorcaserin ) voluntarily withdraw the weight-loss drug from the U.S. market because a safety c ... read article

KEYNOTE-355 trial: Pembrolizumab in combination with chemotherapy met primary endpoint of progression-free survival as first-line treatment for metastatic triple-negative breast cancer with expression of PD-L1

The pivotal phase 3 KEYNOTE-355 trial investigating Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free surviva ... read article

JAVELIN Bladder 100: Bavencio is the first immunotherapy to significantly prolong overall survival in locally advanced or metastatic urothelial carcinoma in the first-line setting

Phase III JAVELIN Bladder 100 study met its primary endpoint of overall survival ( OS ) at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastati ... read article

FDA: Calquence for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

The FDA ( U.S. Food and Drug Administration ) has approved Calquence ( Acalabrutinib ) for the treatment of adult patients with chronic lymphocytic leukemia ( CLL ) or small lymphocytic lymphoma ( SLL ... read article

FDA has approved Invokana, a SGLT2 inhibitor, to treat diabetes-related kidney disease

Invokana ( Canagliflozin ) has been approved by the U.S. Food and Drug Administration ( FDA ) to reduce the risk of end-stage kidney disease ( ESKD ) and cardiovascular events in patients with type 2 ... read article

IMpower131: patients with advanced squamous NSCLC and with high PD-LI expression, treated with Carboplatin + nab-Paclitaxel + Atezolizumab, have experienced a longer survival rate

Patients with stage IV squamous non-small cell lung cancer ( NSCLC ) enrolled in clinical trial to test the immunotherapy Atezolizumab ( Tecentriq ) and chemotherapy against chemotherapy alone experie ... read article

KEYNOTE-024 three-year survival update: Pembrolizumab effective as first-line therapy for advanced non-small-cell lung cancer

First line Pembrolizumab ( Keytruda ) monotherapy provides durable long-term overall survival benefit compared to chemotherapy, according to data presented at the IASLC 2019 World Conference on Lung C ... read article

Belantamab mafodotin, positive headline results from the pivotal DREAMM-2 study for multiple myeloma

Positive results from the pivotal DREAMM-2 open-label, randomised study of two doses of Belantamab mafodotin ( GSK2857916 ) were announced. The 196 patients in the trial had relapsed multiple myelo ... read article

EMA has rejected the marketing authorization of the osteoporosis drug Evenity

The European Medicines Agency ( EMA ) has recommended the refusal of the marketing authorisation for Evenity, a medicine intended for the treatment of osteoporosis. Evenity was developed as a medic ... read article

FDA approves first treatment for chronic rhinosinusitis with nasal polyps: Dupixent

The FDA ( U.S. Food and Drug Administration ) has approved Dupixent ( Dupilumab ) to treat adults with nasal polyps accompanied by chronic rhinosinusitis ( prolonged inflammation of the sinuses and na ... read article

Keytruda as monotherapy for patients with metastatic small cell lung cancer with disease progression on or after Platinum-based chemotherapy and at least one other prior line of therapy: FDA approved

The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as monotherapy for the treatment of patients with metastatic small cell lung cancer ( SCLC ... read article

Long-term survival benefit for metastatic melanoma patients treated with Dabrafenib plus Trametinib

The results from COMBI-d and COMBI-v clinical trials were presented at the 2019 American Society of Clinical Oncology ( ASCO ) Annual Meeting and published simultaneously in The New England Journal of ... read article

Larotrectinib efficacy in patients with TRK fusion cancer and primary CNS tumors or brain metastases

A new analysis from clinical trials in patients with TRK fusion cancer and brain metastases or primary tumors of the central nervous system ( CNS ) has confirmed the strong activity of Larotrectinib ( ... 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