Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study Men who received 177Lu-PSMA-617 plus best standard of care had a 38% reduction in risk of death (median OS benefit of 4 months) and a 60% reduction in the risk of radiographic disease progression or death (median rPFS benefit of 5 months) compared to best standard of care alone[1] Significant improvement demonstrated in all key secondary endpoints, including time to first symptomatic skeletal event, overall response rate and disease control rate[1] VISION study findings to be presented during 2021 ASCO plenary; regulatory submissions to US and EU Health Authorities on track for 2H21; two additional pivotal studies in earlier lines of treatment for metastatic prostate cancer to start 1H21, goal to move into earlier stages of disease
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EAST HANOVER, N.J., June 3, 2021 /PRNewswire/ Novartis today reported the final analysis from the NETTER-1 phase III study comparing treatment using Lutathera
® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors. The previously reported primary analysis of the trial demonstrated a statistically significant improvement in progression free survival (PFS) (HR: 0.18 , p 0.0001)
3. In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months [48.0 months (95%CI: 37.4-55.2) compared to the control arm (36.3 months (95%CI: 25.9-51.7)]
On Monday, a case was filed in District of Columbia District Court by Novartis Pharmaceuticals Corporation against Diana Espinosa and Xavier Becerra in
Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis
- Approval for moderate to severe pediatric patients six years and older is based on pivotal trial data showing Cosentyx demonstrated superior improvements of skin symptoms compared to placebo(1)
- The safety profile of Cosentyx in pediatric patients with plaque psoriasis was demonstrated in two Phase III trials(1)
- Plaque psoriasis is a chronic, inflammatory disease that may impact up to 350,000 children worldwide, with onset most common during adolescence(2,3)
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EAST HANOVER, N.J., June 1, 2021 /PRNewswire/ Novartis, a leader in immuno-dermatology and rheumatology, today announced the U.S. Food and Drug Administration (FDA) has approved Cosentyx