MedicineNews.net - Medical Updates

FDA: four-week dosing approved in all Imfinzi indications, reducing medical visits and improving patient convenience

Imfinzi ( Durvalumab ) has been approved in the US for an additional dosing option, a 1,500 mg fixed dose every four weeks, in the approved indications of unresectable stage III non-small cell lung ca ... read article

Xalkori for the treatment of pediatric ALK-positive anaplastic large cell lymphoma: FDA has accepted supplemental new drug application

The FDA ( U.S. Food and Drug Administration ) has accepted and granted priority review to the supplemental New Drug Application( sNDA ) for Crizotinib ( Xalkori ) for the treatment of pediatric patien ... read article

IMpower010: Atezolizumab improves disease-free survival in people with resectable early stage lung cancer compared to best supportive care

The phase III IMpower010 study evaluating Atezolizumab ( Tecentriq ), compared with best supportive care ( BSC ), has met its primary endpoint of disease-free survival ( DFS ) at the interim analysis. ... read article

CheckMate -816 trial: Nivolumab plus chemotherapy has shown statistically significant improvement in pathologic complete response as neoadjuvant treatment of resectable non-small cell lung cancer

The phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response ( pCR ) in resectable non-small cell lung cancer ( NSCLC ). In the trial, significantly more patients treated ... read article

Opdivo plus Yervoy combined with two cycles of chemotherapy as first-line treatment of metastatic non-small cell lung cancer, positive CHMP opinion

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has recommended approval of Opdivo ( Nivolumab ) plus Yervoy ( Ipilimumab ) with two cycles of Plat ... read article

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

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

ARCTIC trial in third-line non-small cell lung cancer: Durvalumab monotherapy showed a clinically-meaningful reduction in the risk of death compared to chemotherapy

Results from the phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer ( NSCLC ) who have received at least two prior treatments, were announced. This rand ... read article

Pembrolizumab improves overall survival and progression-free survival as first-line treatment for squamous non-small cell lung cancer (NSCLC) in KEYNOTE-407 trial

The pivotal phase 3 KEYNOTE-407 trial investigating Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, in combination with Carboplatin-paclitaxel or nab-Paclitaxel, as first-line treatment for metastat ... read article

Mvasi, a biosimilar to the cancer drug Avastin, approved from FDA for certain colorectal, lung, brain, kidney and cervical cancers

The FDA ( Food and Drug Administration ) has approved Mvasi ( Bevacizumab-awwb ) as a biosimilar to Avastin ( Bevacizumab ) for the treatment of multiple types of cancer. Mvasi is the first biosimil ... read article

Update on European application for Keytruda in combination with Pemetrexed and Carboplatin for first-line treatment of nonsquamous non-small cell lung cancer

Merck ( MSD ) has withdrawn its European application for Keytruda ( Pembrolizumab ) in combination with Pemetrexed and Carboplatin as a first-line treatment for metastatic nonsquamous non-small cell l ... read article

Keytruda in recurrent or metastatic head and neck cancer, FDA granted priority review

The FDA ( Food and Drug Administration ) has accepted for review the supplemental Biologics License Application ( sBLA ) for Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, for the treatment of pati ... read article

Giotrif, overall survival benefit for patients with EGFR mutation-positive non-small cell lung cancer

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion for an update to the European label for Giotrif ( Afatinib ), strengt ... read article