Jeff Legos, Chief Oncology Officer at Pfizer, ) recently shared FDA approval based on the Phase III PATINA trial data on LinkedIn:
“Today the U.S. FDA approved our CDK4/6 inhibitor as part of a maintenance therapy regimen for adult patients with HR+, HER2+ locally advanced or metastatic Breast Cancer (MBC) following induction treatment. For patients and families navigating MBC and their healthcare providers, this approval brings a new evidence-based option at a critical point in care – where extending disease control can make a meaningful difference. The approval is based on positive results from a Phase 3 trial sponsored by Alliance Foundation Trials, LLC.
Despite important progress in treating this form of breast cancer, many patients still face disease progression as resistance develops to existing anti-HER2 and endocrine therapies. That’s why continued innovation and new approaches that may help delay disease progression remain so critical.
This milestone builds on Pfizer’s more than 25 years of commitment to advancing care for people living with MBC. It reflects years of collaboration across the research community, the dedication of research teams and clinical partners, and the courage of patients and families who participated in the trial and helped make this progress possible.”
Rishabh Jain, Medical Oncologist at AIIMS, also shared the update on X:
“PATINA is now an FDA-approved standard.
One year after the practice-changing data, the FDA has officially approved palbociclib + trastuzumab (± pertuzumab) + endocrine therapy as maintenance for HR+/HER2+ metastatic breast cancer.
PATINA
- HR+/HER2+ LA/MBC after induction taxane + trastuzumab ± pertuzumab
- Palbociclib + anti-HER2 + ET vs anti-HER2 + ET
- PFS: HR 0.76 (95% CI 0.59-0.97; P=0.0134)
- OS: Not mature
This is the first FDA approval of a CDK4/6 inhibitor in HER2-positive metastatic breast cancer and formally establishes maintenance CDK4/6 inhibition as a new treatment standard. Will PATINA change your first-line maintenance approach?”
