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

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

Selumetinib, a MEK inhibitor, in combination with Dacarbazine does not effective in uveal melanoma

The phase 3 SUMIT study of Selumetinib in combination with Dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. Th ... read article