Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved IBRANCE (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer following induction treatment. This approval establishes IBRANCE as the first and only CDK4/6 inhibitor indicated for patients with HR+ metastatic breast cancer regardless of HER2 status, addressing a clinical challenge regarding treatment resistance.

The regulatory decision is based on positive results from the Alliance Foundation Trials, LLC (AFT)-sponsored Phase 3 PATINA trial. The study demonstrated a 24% reduction in the risk of progression or death following induction treatment with the addition of IBRANCE to anti-HER2 and endocrine therapies compared to anti-HER2 and endocrine therapies alone. The hazard ratio was 0.76 [95% CI, 0.59, 0.97] with a one-sided p=0.0134.

"Resistance to dual anti-HER2 and endocrine therapy remains a central clinical challenge for patients with HR+, HER2+ metastatic breast cancer – even after an excellent response to initial treatment," said Otto Metzger, M.D., principal investigator of the trial for Alliance Foundation Trials and Medical Oncologist at the Dana-Farber Cancer Institute. "Based on the results from the PATINA study, the addition of IBRANCE in the maintenance phase can meaningfully extend the time patients go without their disease progressing."

PATINA Trial Details

The PATINA trial (AFT-38) was a randomized, open-label global Phase 3 study evaluating the efficacy and safety of IBRANCE in combination with anti-HER2 therapy and endocrine therapy versus anti-HER2 therapy and endocrine therapy alone. Participants received a median of 6 cycles of induction treatment before randomization. The primary endpoint was progression-free survival (PFS) as assessed by the investigator.

The safety and tolerability of IBRANCE in the PATINA trial were consistent with its known safety profile. The most commonly reported adverse events were hematologic toxicities, such as decreased white blood cell count and decreased neutrophil count. Non-hematologic adverse events included diarrhea, infections, stomatitis, and fatigue, which were generally mild to moderate in severity.

Clinical Context and Indication

Approximately 10% of all breast cancers are HR+, HER2+, a subtype sometimes referred to as double-positive or triple-positive breast cancer. Historically, limited research has focused specifically on this subtype in metastatic breast cancer. The PATINA study is the first registrational study to explore the potential of CDK4/6 inhibition in this population.

Since its initial regulatory approval in 2015, IBRANCE has been prescribed to more than 900,000 patients and is approved in more than 100 countries. It continues to be a standard-of-care first-line treatment for HR+, HER2- metastatic breast cancer. With this new approval, Pfizer aims to strengthen confidence in IBRANCE as a CDK4/6 inhibitor backbone across combination regimens.

Recent Developments

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 company 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.

Pfizer shares were up 0.96% at $24.27 during premarket trading on Thursday.

Pfizer Inc. announced that its board of directors declared a $0.43 per share cash dividend for the third quarter of 2026. The dividend is payable on September 1, 2026, to holders of the company's common stock of record at the close of business on July 24, 2026. This payment represents the 351st consecutive quarterly dividend distributed by the company.

Pfizer affirmed its commitment to maintaining and, over the longer term, growing the dividend as part of its capital allocation strategy. The company emphasized that this consistent distribution reflects its financial stability and focus on shareholder returns.

Dividend Details