MedicineNews.net - Medical Updates

Osimertinib: 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 Osimertinib ( Tagrisso ) 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

Keytruda monotherapy in patients whose cancers are tumor mutational burden-high who have progressed following prior treatment: sBLA accepted by FDA

The FDA ( U.S. Food and Drug Administration ) has accepted and granted priority review for a new supplemental Biologics License Application ( sBLA ) for Keytruda ( Pembrolizumab ), an anti-PD-1 therap ... read article

Squamous cell carcinoma of the head and neck: JAVELIN Head and Neck 100 discontinued due to efficacy doubts

An update from the phase III JAVELIN Head and Neck 100 study evaluating Avelumab ( Bavencio ) in addition to chemoradiotherapy ( CRT ) versus standard-of-care CRT in patients with untreated locally ad ... read article

Possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR, FDA continues to evaluate the trial results

The FDA ( U.S. Food and Drug Administration ) has alerted the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Be ... read article

Loncastuximab tesirine in patients with relapsed or refractory diffuse large b-cell lymphoma

Positive results from the pivotal 145-patient phase 2 clinical trial of Loncastuximab tesirine ( ADCT-402 ) for the treatment of relapsed or refractory diffuse large B-cell lymphoma ( DLBCL ) were an ... read article

Nivolumab plus Ipilimumab has shown continued survival benefit at 42-month follow-up in patients with previously untreated advanced or metastatic renal cell carcinoma

Updated results from the phase 3 CheckMate -214 study evaluating the combination of Nivolumab ( Opdivo ) plus Ipilimumab ( Yervoy ) versus Sunitinib( Sutent ) in patients with previously untreated adv ... read article

Muscle-invasive urothelial cancer: Atezolizumab as adjuvant monotherapy treatment did not meet its primary endpoint in IMvigor010

The phase III IMvigor010 study evaluating Atezolizumab ( Tecentriq ) as an adjuvant ( after surgery ) monotherapy treatment did not meet its primary endpoint of disease-free survival ( DFS ) compared ... read article

FIREFISH trial in infants with type 1 spinal muscular atrophy: Risdiplam has demonstrated motor improvement

Positive results from the pivotal Part 2 of the FIREFISH study, evaluating Risdiplam in infants aged 1-7 months with type 1 spinal muscular atrophy ( SMA ) were announced. The primary outcome measu ... read article

Keytruda in patients with high-risk, non-muscle invasive bladder cancer

The FDA ( U.S. Food and Drug Administration ) has accepted and granted priority review for a new supplemental Biologics License Application ( sBLA ) for Keytruda ( Pembrolizumab ), an anti-PD-1 therap ... read article

Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment

The EMA's Committee for Medicinal Products for Human Use ( CHMP ) has recommended the approval of Kadcyla ( Trastuzumab emtansine ) for the adjuvant treatment of adult patients with HER2-positive earl ... read article

Revlimid in combination with Rituximab for the treatment of adult patients with previously treated follicular lymphoma

The European Medicines Agency's ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the approval of Revlimid ( Lenalidomide ) in combination wi ... read article

Mayzent for the treatment of adult patients with active secondary progressive multiple sclerosis: CHMP has granted positive opinion

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion for Mayzent ( Siponimod ) for the treatment of adult patients with s ... read article

Metastatic or unresectable recurrent head and neck squamous cell carcinoma: Keytruda, as monotherapy or in combination with Platinum and 5-Fluorouracil chemotherapy, in patients whose tumors express PD-L1

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of two regimens of Keytruda ( Pembrolizumab ), ... read article

Atezolizumab in combination with Bevacizumab has increased overall survival and progression-free survival in people with unresectable hepatocellular carcinoma

The phase III IMbrave150 study, evaluating Atezolizumab ( Tecentriq ) in combination with Bevacizumab ( Avastin ) as a treatment for people with unresectable hepatocellular carcinoma ( HCC ) who have ... read article

Ixekizumab superior to Guselkumab in people with moderate to severe plaque psoriasis

Data were presented at the 5th Annual Maui Derm NP+PA Fall meeting from the phase 4 IXORA-R study, the first head-to-head ( H2H ) study between an IL-17A inhibitor and an IL-23/p19 inhibitor using the ... read article