Piqray receives approval in Europe for HR+/HER2- advanced breast cancer with a PIK3CA mutation

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Piqray (alpelisib) received approval from the European Commission in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.

Piqray is sponsored by Novartis.

Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumors harbor a PIK3CA mutation, which stimulates tumor growth and is associated with poor response to therapy.

This approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use of the European Medicines Agency based on the phase III SOLAR-1 trial showing that Piqray nearly doubled median progression-free survival compared to fulvestrant alone.

Overall response rate was more than doubled when Piqray was added to fulvestrant compared to fulvestrant alone.

Table of Contents

YOU MAY BE INTERESTED IN

Secretary of the U.S. Department of Health and Human Services Robert F. Kennedy Jr. appeared before the House Energy and Commerce Subcommittee on Health to defend the HHS fiscal year 2026 budget proposal, and faced criticism from several Democratic lawmakers on what they described as a lack of transparency and scientific rigor in the agency’s recent decisions.

The full-scale Russian invasion of Ukraine has devastated the Ukrainian healthcare infrastructure, disrupting cancer care, halting clinical trials, and compounding long-standing systemic challenges.  Even before the war, Ukraine’s oncology system faced major constraints: Limited access to radiotherapy equipment, outdated chemotherapy supply chains, and workforce shortages. The invasion intensified these issues—cancer hospitals were damaged, warehouses destroyed,...

Patients affected by cancer are increasingly turning to artificial intelligence-powered chatbots, such as ChatGPT and Gemini, for answers to pressing health questions. These tools, available around the clock and free from geographic or scheduling constraints, are appealing when access to medical professionals is limited by financial, language, logistical, or emotional barriers. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login