Xagena.net - Update in Medicine

FDA has approved first cell-based gene therapy for adult patients with multiple myeloma: Abecma

The FDA ( U.S. Food and Drug Administration ) has approved Abecma ( Idecabtagene vicleucel ), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whos ... read article

VISION study with 177Lu-PSMA-617 has met both primary endpoints, significantly improving overall survival and radiographic progression-free survival in patients with PSMA-positive metastatic castration-resistant prostate cancer

The first interpretable results of the phase III VISION study evaluating the efficacy and safety of 177Lu-PSMA-617, a targeted radioligand therapy in patients with progressive PSMA-positive metastatic ... read article

FDA has approved Libtayo for non-small cell lung cancer with high PD-L1 expression

The Food and Drug Administration ( FDA ) has approved Libtayo ( Cemiplimab-rwlc, Cemiplimab ) for the first-line treatment of patients with advanced non-small cell lung cancer ( NSCLC ) ( locally adva ... read article

European Union: Keytruda, an anti-PD-1 therapy, approved for metastatic microsatellite instability-high colorectal cancer patients

The European Commission ( EC ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability ... read article

FDA has approved Alunbrig for ALK-positive metastatic non-small cell lung cancer

The FDA ( Food and Drug Administration ) has approved Alunbrig ( Brigatinib ) for adult patients with anaplastic lymphoma kinase ( ALK )-positive metastatic non-small cell lung cancer ( NSCLC ) as det ... read article

CheckMate -649: overall survival and progression-free survival was superior with Nivolumab plus chemotherapy versus chemotherapy in first-line treatment of gastric and esophageal cancers

CheckMate -649, a pivotal phase 3 trial evaluating Nivolumab ( Opdivo ) plus chemotherapy compared to chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junct ... read article

Keytruda approved by FDA for patients with TMB-high solid tumors

The FDA ( Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ) for the treatment of adults and pediatric patients with unresectable or metastatic tumor mutational burden-high ( TMB-H ... read article

Atezolizumab in combination with chemotherapy has met primary endpoint of improved pCR, regardless of PD-L1 status, as initial treatment for patients with early triple-negative breast cancer

The phase III IMpassion031 study, evaluating Atezolizumab ( Tecentriq ) in combination with chemotherapy ( Abraxane, albumin-bound Paclitaxel; nab-Paclitaxel; followed by Doxorubicin and Cyclophospham ... read article

CITYSCAPE trial: promising results adding Tiragolumab to Atezolizumab in patients with PD-L1-positive metastatic non-small cell lung cancer

Results from the phase II CITYSCAPE trial were published. This is the first randomised study evaluating the efficacy and safety of Tiragolumab plus Atezolizumab ( Tecentriq ) compared with Atezolizuma ... read article

CheckMate -9ER trial: Cabozantinib in combination with Nivolumab has shown clinically meaningful efficacy results across all endpoints in untreated advanced renal cell carcinoma

CheckMate -9ER, a pivotal phase III trial evaluating Cabozantinib ( Cabometyx ) in combination with Nivolumab ( Opdivo ) compared to Sunitinib in previously untreated advanced or metastatic renal cell ... read article

Osimertinib, phase III 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 Tagrisso ( Osimertinib ) 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

CheckMate -025 trial: 26% of patients treated with Nivolumab are alive at five years in previously treated advanced or metastatic renal cell carcinoma

Five-year follow-up results from the phase 3 CheckMate -025 study continue to demonstrate that treatment with Nivolumab ( Opdivo ) delivers superior overall survival ( OS ) and objective response rate ... read article

FDA has required the withdrawal of the weight-loss drug Belviq from the market: potential risk of cancer outweighs the benefits

The FDA ( U.S. Food and Drug Administration ) has requested that the manufacturer of Belviq, Belviq XR ( Lorcaserin ) voluntarily withdraw the weight-loss drug from the U.S. market because a safety c ... read article

KEYNOTE-355 trial: Pembrolizumab in combination with chemotherapy met primary endpoint of progression-free survival as first-line treatment for metastatic triple-negative breast cancer with expression of PD-L1

The pivotal phase 3 KEYNOTE-355 trial investigating Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free surviva ... read article

JAVELIN Bladder 100: Bavencio is the first immunotherapy to significantly prolong overall survival in locally advanced or metastatic urothelial carcinoma in the first-line setting

Phase III JAVELIN Bladder 100 study met its primary endpoint of overall survival ( OS ) at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastati ... read article