Novartis’ prostate cancer drug shows positive results in trial; Gets EMA recommendation | The Financial Express

Novartis’ prostate cancer drug shows positive results in trial; Gets EMA recommendation

The company claims that the positive CHMP opinion is based on data from the Phase III VISION study, in which Pluvicto demonstrated significantly improved overall survival among patients.

Novartis’ prostate cancer drug shows positive results in trial; Gets EMA recommendation
The company claims that it has led to an increase in the total value driven for the provider network by over 30 percent. (File)

Novartis on Friday announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Pluvicto.

According to the pharma major, it is a radioligand therapy, in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with progressive prostate cancer.

“People at this advanced stage of the disease have already received many different treatments and have few alternatives left. If approved in Europe, Pluvicto® would represent a new type of precision medicine targeting a biomarker broadly expressed in prostate cancer patients4 and provide a therapeutic option with demonstrated potential to improve outcomes1. As a clinician this gives me hope for patients facing a very difficult situation,” said Prof. Karim Fizazi, MD, PhD, VISION trial investigator and Head of Medical Oncology at Gustave Roussy, first European cancer center based in Villejuif, France.

The company claims that the positive CHMP opinion is based on data from the Phase III VISION study, in which Pluvicto demonstrated significantly improved overall survival among patients.

“Results from the VISION trial demonstrated that participants treated with Pluvicto plus BSoC had a 38% reduction in risk of death and a 60% reduction in the risk of radiographic disease progression or death (rPFS) compared to BSoC alone1. In addition, approximately a third (29.8%) of patients with evaluable disease at baseline demonstrated an overall response (per RECIST 1.1) with Pluvicto plus BSoC, compared to 1.7% in the BSoC alone arm1. The most common adverse events (all grades) in the Pluvicto arm of the study were fatigue (43%), dry mouth (39%), nausea (35%), anemia (low red blood cell counts) (32%), decreased appetite (21%), and constipation (20%),” the company stated on Friday.

The company also informed that the CHMP’s positive opinion on Pluvicto in PSMA–positive mCRPC patients will be referred to the European Commission (EC), which will deliver a final decision in approximately two months. The decision will be applicable to all 27 EU member states plus Iceland, Norway, Northern Ireland and Liechtenstein, it stated.

“This positive CHMP opinion for Pluvicto is an important step forward in our goal of bringing transformative innovation to more patients around the world. If approved by the European Commission, Pluvicto would be the first and only commercial radioligand therapy for people with advanced prostate cancer in Europe. We are committed to exploring the potential of radioligand therapy to address unmet needs in prostate cancer, including in earlier stages of disease,” said Marie-France Tschudin, President, Innovative Medicines International & Chief Commercial Officer, Novartis in a statement.

ALSO READ | Novartis unveils new plan based on eight multi-billion dollar brands; To prioritise US market

Get live Share Market updates and latest India News and business news on Financial Express. Download Financial Express App for latest business news.

First published on: 14-10-2022 at 06:48:11 pm
Photos
7 Photos
WOW! Tourists enjoy frozen waterfall in Baramulla’s Drung – See Stunning Photos
13 Photos
Delhi: Rehearsals for Beating Retreat ceremony in full swing – Photos
12 Photos
Frosty feast to the eyes! Ministry of Railways shares mesmerising pictures of snow clad Hiller Shahabad railway station