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Keytruda approved by FDA for patients with TMB-high solid tumors

The FDA ( Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ) for the treatment of adults and pediatric patients with unresectable or metastatic tumor mutational burden-high ( TMB-H ... read article

Atezolizumab in combination with chemotherapy has met primary endpoint of improved pCR, regardless of PD-L1 status, as initial treatment for patients with early triple-negative breast cancer

The phase III IMpassion031 study, evaluating Atezolizumab ( Tecentriq ) in combination with chemotherapy ( Abraxane, albumin-bound Paclitaxel; nab-Paclitaxel; followed by Doxorubicin and Cyclophospham ... read article

RECOVERY trial: Dexamethasone reduces COVID-19 patient deaths by one-third

A trial launched in March 2020 has released its results, finding that Dexamethasone reduced deaths of ventilated COVID-19 patients by one-third. The RECOVERY trial was established as a randomised c ... read article

CITYSCAPE trial: promising results adding Tiragolumab to Atezolizumab in patients with PD-L1-positive metastatic non-small cell lung cancer

Results from the phase II CITYSCAPE trial were published. This is the first randomised study evaluating the efficacy and safety of Tiragolumab plus Atezolizumab ( Tecentriq ) compared with Atezolizuma ... read article

CheckMate -9ER trial: Cabozantinib in combination with Nivolumab has shown clinically meaningful efficacy results across all endpoints in untreated advanced renal cell carcinoma

CheckMate -9ER, a pivotal phase III trial evaluating Cabozantinib ( Cabometyx ) in combination with Nivolumab ( Opdivo ) compared to Sunitinib in previously untreated advanced or metastatic renal cell ... read article

Osimertinib, phase III ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment of patients with EGFR-mutated lung cancer

The ADAURA phase III trial for Tagrisso ( Osimertinib ) in the adjuvant treatment of patients with stage IB, II and IIIA epidermal growth factor receptor-mutated ( EGFRm ) non-small cell lung cancer ( ... read article

FDA has approved clinical trial for Tocilizumab to treat hospitalized patients with severe COVID-19 pneumonia

The FDA ( U.S. Food & Drug Administration ) has approved a randomized, double-blind, placebo-controlled phase III clinical trial in collaboration with BARDA ( Biomedical Advanced Research and Deve ... read article

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

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