Gilead scores approval for breast cancer drug

Pharma News: Gilead’s $21 billion acquisition of Immunomedics and its potential blockbuster continues to pay off.

Trodelvy (sacituzumab govitecan) is now indicated for adults with triple-negative breast cancer (TNBC) who have received at least two previous therapies for metastatic disease, as per full approval from U.S. Food and Drug Administration (FDA).

The Therapeutic Drugs Administration (TGA) was criticised recently as lengthy processes have denied terminal patients from access to this treatment. As of March 2021, the TGA has accepted the application for a priority review of Trodelvy.

“Women with triple-negative breast cancer have historically had very few effective treatment options and faced a poor prognosis,” said Dr Aditya Bardia, Director of Breast Cancer Research Program, Mass General Cancer Centre and Assistant Professor of Medicine at Harvard Medical School, and global principal investigator of the ASCENT study. “The approval reflects the statistically significant survival benefit seen in the landmark ASCENT study and positions Trodelvy as a potential standard of care for pre-treated TNBC.”

“A metastatic TNBC diagnosis is frightening. As an aggressive and difficult-to-treat disease, it’s a significant advance to have this treatment option with a proven survival benefit for patients with metastatic disease that continues to progress,” said Ricki Fairley, Founder and CEO of Touch, the Black Breast Cancer Alliance. “For far too long, people with metastatic TNBC had very few treatment options. This news continues the progress of bringing more options to treat this devastating disease.”

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Trodelvy also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death.

“This approval is the culmination of a multi-year development program and validates the clinical benefit of this important treatment in metastatic TNBC,” said Dr Merdad Parsey, Chief Medical Officer, Gilead Sciences. “Building upon this milestone, we are committed to advancing Trodelvy with worldwide regulatory authorities so that, pending their decision, Trodelvy may become available to many more people around the world who are facing this difficult-to-treat cancer.”

Regulatory submissions have also been filed in the United Kingdom, Canada and Switzerland as part of Project Orbis, an initiative of the FDA Oncology Centre of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners, as well as in Singapore through our partner Everest Medicines. The European Medicines Agency has also validated a Marketing Authorisation Application for Trodelvy in the European Union.