Xagena.net - Update in Medicine

Darzalex Faspro for newly diagnosed light chain amyloidosis, accelerated approval by FDA

The FDA ( Food and Drug Administration ) has granted accelerated approval to Darzalex Faspro ( Daratumumab plus hyaluronidase ) in combination with Bortezomib, Cyclophosphamide and Dexamethasone for n ... 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 Verquvo for patients with symptomatic chronic heart failure

The U.S. Food and Drug Administration ( FDA ) has approved soluble guanylate cyclase ( sGC ) stimulator Vericiguat under the brand name Verquvo. Vericiguat 2.5 mg, 5 mg, and 10 mg is indicated to re ... read article

Donanemab slows clinical decline of Alzheimer's disease

Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measure of cognition and daily function in patient ... read article

FDA has approved Onureg for acute myeloid leukemia

The FDA ( Food and Drug Administration ) has approved Azacitidine tablets ( Onureg ) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission ( CR ) or com ... 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

ACTT-2 trial: Baricitinib has significant effect on recovery time in COVID-19 patients requiring Oxygen

Baricitinib in combination with Remdesivir has reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with Remdesivir. This finding was part of additio ... 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

Tecartus: the first and only CAR T treatment for relapsed or refractory mantle cell lymphoma, FDA approved

The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Tecartus ( Brexucabtagene autoleucel, formerly KTE-X19 ), the first and only approved chimeric antigen receptor ( CAR ... 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

RECOVERY trial: Dexamethasone reduces COVID-19 patient deaths by one-third

A trial launched in March 2020 has released its results, finding that Dexamethasone reduced deaths of ventilated COVID-19 patients by one-third. The RECOVERY trial was established as a randomised c ... 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