Novartis receives FDA approval 177Lu-PSMA-617 for metastatic castration resistant prostate cancer

FDA breakthrough therapy for Novartis metastatic prostate cancer drug

Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to 177 Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy1.

Breakthrough therapy designation granted based on positive data from the pivotal, Phase III VISION study evaluating 177 Lu-PSMA-617, a targeted radioligand therapy, plus standard of care (SOC), compared to SOC alone, in patients with progressive PSMA-positive mCRPC2.


Phase III VISION study demonstrated that 177 Lu-PSMA-617 significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC2
The five-year survival rate for patients with metastatic prostate cancer is approximate 30%.

Novartis is a global leader in radioligand therapy, uniquely positioned with broad commercial experience, established manufacturing and supply chain capabilities, and extensive development expertise

Two additional studies with 177 Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition).

Tags : #Prostate #metastaticProstateCancer #FDAApproval #FDANewsLatest #Novartis

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-



Trending Now

Why is Early Intervention (EI) so important for autism?November 30, 2022
Heart failure – Symptoms, risk factors, and treatmentNovember 30, 2022
How to consume Bulletproof coffee for weight loss?November 30, 2022
MedySeva Gives New Dimension to Affordable TelehealthNovember 29, 2022
A mental healthcare revolution with Trijog November 29, 2022
Health Basix – In-school healthcare partner for your kidsNovember 28, 2022
Health-tech startup Healthkart raises Rs 536.52 Crore led by TemasekNovember 28, 2022
TummyFriendly Foods – Harmless Bio-available nutrition for little onesNovember 28, 2022
Causes, Symptoms, and Solutions to Lung Cancer November 28, 2022
5 reasons behind premature hair grayingNovember 26, 2022
Connect2MyDoctor’s cARe - Augmented Reality tool playing a crucial role in patient educationNovember 26, 2022
Bollywood Actor Kajal Aggarwal invests in D2c Startup TACNovember 26, 2022
Causes, Symptoms, Treatment, and Preventive Solutions for Ovarian Cancer November 26, 2022
Men’s health firm Bonatra raises Rs 5.5 Cr in the pre-seed funding roundNovember 25, 2022
Why is Samantha Ruth Prabhu hospitalized again in Hyderabad?November 25, 2022
RedBrick AI, a Healthtech startup, raises $4.6 million in funding from Sequoia India, Surge.November 25, 2022
Now schedule your health check-ups at a much-discounted price with MediWheelNovember 24, 2022
Kamal Haasan gets admitted to Chennai Hospital Today November 24, 2022
India's first Global Women's Health Innovation Conference to highlight the potential of Femtech & Digital InnovationsNovember 24, 2022
Pred Health - HealthTech Startup dedicated to provide Integrated care management for cancer patientsNovember 24, 2022