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FDA: Breakthrough Therapy Designation for LOXO-292, a selective RET inhibitor

The FDA ( U.S. Food and Drug Administration ) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for: the treatment of patients with metastatic RET-fusion-positive no ... read article

Target therapy: RG6042, an antisense oligonucleotide, for treatment of Huntington’s disease

The European Medicines Agency ( EMA ) has granted PRIME ( PRIority MEdicines ) designation for an investigational medicine RG6042 ( formerly known as IONIS-HTTRx ) for the treatment of people with Hun ... read article

Imbruvica plus Rituximab approved by FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia

The U.S. Food and Drug Administration ( FDA ) has approved Imbruvica ( Ibrutinib ) plus Rituximab ( Rituxan ) for the treatment of adult patients with Waldenström's macroglobulinemia ( WM ), a rare an ... read article

Yescarta has received European marketing authorization for the treatment of relapsed or refractory diffuse large B-cell lymphom and primary mediastinal large B-cell lymphoma

The European Commission ( EC ) has granted Marketing Authorization for Yescarta ( Axicabtagene ciloleucel ) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma ... read article

Biktarvy for the treatment of HIV-1 infection, approved by European Commission

European Commission has granted Marketing Authorization for Biktarvy ( Bictegravir 50mg / Emtricitabine 200 mg / Tenofovir alafenamide 25 mg; BIC/FTC/TAF ), a once-daily single tablet regimen ( STR ) ... read article

Braftovi plus Mektovi for BRAF V600E, V600K mutation-positive melanoma: FDA approved

The FDA ( US Food and Drug Administration ) has granted approval to Encorafenib ( Braftovi ) and Binimetinib ( Mektovi ) combination therapy for the treatment of patients with unresectable or metastat ... read article

Ovarian cancer: Olaparib significantly delays disease progression in 1st-line SOLO-1 trial

Olaparib ( Lynparza ) met primary endpoint of progression-free survival in women with BRCA-mutated advanced ovarian cancer and showed a safety profile in SOLO-1 trial consistent with previous trials. ... read article

Durvalumab improves overall survival in PACIFIC trial for unresectable stage III non-small cell lung cancer

Positive overall survival ( OS ) results for the phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Durvalumab ( Imfinzi ) in patients with unresectable s ... read article

FDA has approved Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer

The US Food and Drug Administration ( FDA ) has approved Tagrisso ( Osimertinib ) for the 1st-line treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) whose tumours have epiderm ... read article

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

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