On Wednesday, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE:PFE) Ibrance (palbociclib) regimen for frontline maintenance for metastatic breast cancer.
The approval covers Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC) following induction treatment.
FDA Expands Ibrance Use In HR+, HER2+ Breast Cancer
The approval is based on positive results from the Alliance Foundation Trials, LLC (AFT)-sponsored Phase 3 PATINA trial.
The PATINA trial demonstrated a 24% reduction in the risk of progression or death following induction treatment with the addition of IBRANCE to anti-HER2 (trastuzumab or trastuzumab plus pertuzumab) and endocrine therapies compared to anti-HER2 and endocrine therapies alone.
Since its initial regulatory approval in 2015, Ibrance continues to be a standard-of-care first-line treatment for HR+, HER2- MBC, and has been prescribed to more than 900,000 patients and approved in more than 100 countries.
Recent Developments At Pfizer
Earlier this week, Pfizer reported mixed topline results from its Phase 3 SigVie-002 trial of investigational antibody-drug conjugate sigvotatug vedotin in previously treated advanced non-squamous non-small cell lung cancer (NSCLC).
While the study missed its primary overall survival endpoint in the broader patient population, it showed encouraging signals in second-line patients.
In June, the US drug giant announced that Dave Denton is set to step down as CFO on August 15 to take a role in the consumer goods industry, and Cecile Guegan will become interim CFO on August 16 while the company runs a broad search for a permanent successor.
CEO Albert Bourla said Denton helped guide major transactions, including Seagen, Biohaven, and Metsera.
PFE Stock Price Activity: Pfizer shares were up 0.96% at $24.27 during premarket trading on Thursday, according to Benzinga Pro data.
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