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

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

Waldenström's macroglobulinemia: Imbruvica prescribing information updated to include long-term data

The U.S. Food and Drug Administration ( FDA ) has approved the update of the Imbruvica ( Ibrutinib ) Prescribing Information to include efficacy and safety data for the combination of Imbruvica with ... 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

IPATential150 study: Ipatasertib in combination with Abiraterone and Prednisone / Prednisolone met one of its co-primary endpoints in patients with metastatic castration-resistant prostate cancer and PTEN loss

The phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival ( rPFS ) in patients with metastatic castration-resistant prostate cancer ( mCRPC ) and whose tu ... 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

FDA has granted accelerated approval to Zepzelca for metastatic small cell lung cancer

The FDA ( Food and Drug Administration ) has granted accelerated approval to Zepzelca ( Lurbinectedin ) for adult patients with metastatic small cell lung cancer ( SCLC ) with disease progression on o ... read article

CheckMate -577: Nivolumab as adjuvant therapy for patients with resected esophageal or gastroesophageal junction cancer, has met primary endpoint of disease-free survival

The phase 3 CheckMate -577 trial evaluating Nivolumab ( Opdivo ) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction ( GEJ ) cancer met its primary endpoint of di ... read article

Venetoclax plus Azacitidine has demonstrated overall survival benefit and improved remission rates in treatment-naïve acute myeloid leukemia patients

The results from the VIALE-A trial, which has demonstrated that previously-untreated patients with acute myeloid leukemia ( AML ) who were ineligible for intensive chemotherapy treated with Venetoclax ... 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

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