FDA Backs PFE's Tukysa Combo in Front-Line Maintenance Breast Cancer
Pfizer PFE announced that the FDA has approved its marketed drug, Tukysa (tucatinib), in combination with Roche’s RHHBY Herceptin (trastuzumab) and Perjeta (pertuzumab) for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.
The latest approval expands Tukysa’s use into the frontline setting, providing a chemotherapy-free maintenance treatment option for patients following initial induction therapy. The approval was supported by data from the phase III HER2CLIMB-05 study.
Data from the study showed that treatment with Tukysa in combination with RHHBY’s Herceptin and Perjeta reduced the risk of disease progression or death by 35.9% versus placebo plus Herceptin and Perjeta.
The median progression-free survival was 24.9 months in the Tukysa arm compared with 16.3 months in the placebo arm, representing an 8.6-month improvement.
The safety profile of the Tukysa regimen was generally consistent with its known profile, although hepatotoxicity was more severe.
PFE’s Price Performance
Year to date, shares of Pfizer have rallied 18.3% compared with the industry’s increase of 11.7%.
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The latest FDA nod expands the use of Tukysa beyond its existing second-line indication in HER2-positive metastatic breast cancer. Pfizer noted that the drug is already an NCCN Category 1 second-line plus treatment for patients with HER2-positive metastatic breast cancer in the United States.
The December 2023 acquisition of Seagen strengthened Pfizer’s oncology portfolio by adding four antibody-drug conjugates or ADCs — Adcetris, Padcev, Tukysa and Tivdak.
PFE’s Strong Position in Oncology Space
Pfizer is one of the world’s leading oncology drugmakers with a broad portfolio of marketed cancer therapies as well as a deep oncology pipeline.
The company’s oncology revenues grew 5% in the first half of 2026, driven by drugs like Xtandi, Lorbrena, the Braftovi-Mektovi combination and Padcev. Pfizer considers Padcev to be a potential growth driver in the oncology segment and plans to invest in this asset.
The company is also rebuilding its pipeline in oncology. A key candidate in its oncology pipeline is PF-08634404, a dual PD-1/VEGF inhibitor in-licensed from Chinese biotech 3SBio in 2025. Pfizer has initiated nine studies, including two pivotal phase III studies for PF-08634404 in first-line metastatic colorectal cancer and first-line NSCLC. Pfizer aims to establish PF-08634404 as a potential backbone therapy across multiple tumor types. By 2030, Pfizer expects to have eight or more blockbuster oncology medicines in its portfolio.
PFE’s Zacks Rank & Key Pick
Pfizer currently carries a Zacks Rank #2 (Buy).
A top-ranked stock in the biotech sector is Inovio Pharmaceuticals INO, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from 99 cents to 72 cents. During the same time, estimates for 2027 loss per share have narrowed from 46 cents to 44 cents. INO shares have lost 33.6% year to date.
Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 69.05%.
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This article originally published on Zacks Investment Research (zacks.com).
