MedicineNews.net - Medical Updates

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

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

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

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

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

TRK fusion cancer: updated analysis for Larotrectinib has confirmed high response rate and durable responses over three years in children and adults

Updated clinical data for Larotrectinib ( Vitrakvi ) in adult and pediatric patients with TRK fusion cancer showed a high response rate with an overall response rate ( ORR ) of 79% ( 95% CI: 72–85 ) w ... read article

Pooled five-year survival results for Nivolumab in previously-treated advanced non-small cell lung cancer patients

Long-term pooled efficacy and safety results from the phase 3 CheckMate -017 and CheckMate -057 studies in patients with previously treated advanced non-small cell lung cancer ( NSCLC ) were announced ... read article

Entrectinib in NTRK fusion-positive, locally advanced or metastatic solid tumours and metastatic, ROS1-positive non-small cell lung cancer

Entrectinib has shown efficacy in the treatment of adult and paediatric patients with neurotrophic tropomyosin receptor kinase ( NTRK ) fusion-positive, locally advanced or metastatic solid tumours wh ... read article

Long-term survival results from pooled analyses of Nivolumab in previously-treated non-small cell lung cancer patients

Results from pooled analyses of survival data from four studies ( CheckMate -017, -057, -063 and -003; n=664 ) in patients with previously-treated advanced non-small cell lung cancer ( NSCLC ) who wer ... read article