MedicineNews.net - Medical Updates

New frontiers in multiple myeloma: Ciltacabtagene autoleucel, a BCMA-directed CAR-T therapy

Cilta-cel ( Ciltacabtagene autoleucel ) is an investigational BCMA-directed CAR-T therapy in development for the treatment of adults with relapsed and/or refractory multiple myeloma. CAR‑T therapy is ... read article

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

Nivolumab plus chemotherapy and Nivolumab plus Ipilimumab have demonstrated superior survival benefit compared to chemotherapy in unresectable advanced or metastatic esophageal squamous cell carcinoma

Results from the phase 3 CheckMate -648 trial evaluating treatment with Nivolumab ( Opdivo ) plus chemotherapy or Nivolumab plus Ipilimumab ( Yervoy ) in patients with unresectable advanced or metasta ... 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

EV-301 trial: survival advantage of Enfortumab vedotin in patients with previously treated advanced urothelial cancer

Results from the phase 3 EV-301 trial were presented at 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium ( ASCO GU ), and published in The New England Journal of Medicine ( N ... 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