ER degrader for breast cancer receives UK Innovation Passport

Breast cancer

Arvinas and Pfizer UK have been awarded a UK Innovation Passport for vepdegestrant (ARV-471), an investigational PROTAC ER (estrogen receptor) degrader.

It is intended for the treatment of patients with oestrogen receptor (ER)+/ human epidermal growth factor receptor (HER)2- locally-advanced breast cancer or metastatic breast cancer.

The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP). The goal of ILAP is to accelerate the time to market facilitating patient access to medicines in the UK.

The Innovation Passport application is the first step in the ILAP process, which activates the Medicines and Healthcare Regulatory Agency (MHRA) and its partner agencies, including the National Institute for Health and care Excellence (NICE) and the Scottish Medicines Consortium (SMC) to develop a roadmap for regulatory and development milestones.

“This acknowledgment underscores our commitment to advancing medicine and delivering potentially transformative solutions for patients,” said John Houston, President and Chief Executive Officer at Arvinas. “Arvinas is hopeful our investigational PROTAC ER degrader, vepdegestrant, will have the potential to be an option as an endocrine therapy in the treatment for ER+/HER2 metastatic breast cancer.”

A number of Phase I, II and III studies are enrolling globally, investigating vepdegestrant as monotherapy and as a combination therapy for the treatment of ER+/HER2- metastatic breast cancer in the first, second and third line treatment setting.

“We welcome the Innovation Passport designation which will allow Pfizer and Arvinas to discuss access considerations for potential future indications for vepdegestrant,”, added Dr Ruhe Chowdhury, Oncology Medical Director at Pfizer UK. “We look forward to working with the MHRA, NICE and other partners to support a timely review as we aim to bring this potential medicine to eligible patients in the UK.”

Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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