Novartis’ PI3K Inhibitor Piqray Approved in the UK as First Therapy for PIK3CA-Mutated, HR+/HER2- Breast Cancer
Jan 23, 2022 01:31
CST Updated
01:31
Novartis
Drug Development and Manufacturing
Medicines and Healthcare products Regulatory Agency
The MHRA is an executive agency of the UK Department of Health and Social Care, responsible for ensuring that medicines and medical devices work effectively and are safe and reliable. Established in 2003 through the merger of the Medicines Control Agency and the Medical Devices Agency, the organization employs more than 1,300 staff members.
News on January 22, 2022 /BioValleyBIOON/ --Novartis(Novartis) recently announced that the UK Medicines andHealth ProductsThe Administration (MHRA) has approved the expansionBreast CancerNew Drug Piqray (alpelisib) Indication: In combination with fulvestrant for the treatment of postmenopausal women and men with breast cancer. Specifically: patients with locally advanced or metastatic breast cancer who have progressed on or after an endocrine therapy-based regimen, harbor a PIK3CA mutation, are hormone receptor-positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-).
Piqray is an α-specific PI3K kinase inhibitor., which was approved by the United States in May 2019 for the treatment of postmenopausal women and male patients with breast cancer, specifically: patients with locally advanced or metastatic breast cancer who are HR+/HER2-, carry PIK3CA mutations, and have experienced disease progression after receiving endocrine monotherapy.
Piqray is the first to be specifically approved for the treatment ofTumorTreatment Methods for Advanced Breast Cancer Patients with PIK3CA Mutations. This drug has been approved for marketing in many countries around the world.Piqray Has ChangedTumorThe treatment landscape for HR+/HER2- advanced breast cancer patients with PIK3CA mutations provides clinicians with a clear therapeutic approach.
In July 2020, the European Medicines Agency (EMA) approved Piqray in combination with fulvestrant for the treatment of postmenopausal women and male patients with breast cancer. Specifically, the approval is for patients with HR+/HER2- locally advanced or metastatic breast cancer who have progressed on endocrine therapy alone, carry a PIK3CA mutation, and have not previously received a combination of endocrine therapy and CDK4/6 inhibitors. Therefore, to ensure that all eligible patients in the UK have access to more treatment options,NovartisDecided to continue advancing the national approval process and submitted a broader application to the MHRA.
Alpelisib Chemical Structure (Source: selleckchem.com)
Endocrine Therapy Resistance: A Key Challenge in Advanced Breast Cancer Treatment
Piqray Combined with Fulvestrant Has Been Proven: In Endocrine-Resistant HR+/HER2- Advanced Breast Cancer with PIK3CA Mutation, It Significantly Improves Progression-Free Survival (PFS) and Overall Response Rate (ORR), Showing Good Tolerability and Manageable Safety When Appropriate and Timely Patient Care and Follow-Up Are Provided.
Royal Marsden Breast Cancer ConsultantTumorDr. Marina Parton commented: "This approval represents a significant advancement for advanced breast cancer, offering patients more treatment options; in these areas, innovation is urgently needed to deliver better clinical and patient outcomes. Targeted therapies, such as Piqray for treating HR+/HER2- advanced breast cancer with PIK3CA mutations, are a step in the right direction, raising the standard of care and enabling more eligible patients in the UK to access optimal treatment."(Bioon.com)