FDA approves Pfizer’s Tukysa regimen for metastatic breast cancer

PhRMA sued the U.S. government over a Medicare drug pricing program, claiming it imposes illegal foreign price controls. The policy, set to take effect in 2027, bases prices on international averages. PhRMA, representing 34 manufacturers including Pfizer and Sanofi, seeks to block the program, arguing it lacks statutory authority and could harm innovation and patient access.

Pfizer's Tukysa (tucatinib) received FDA approval for maintenance treatment of HER2+ metastatic breast cancer, expanding its use to frontline treatment. The approval, based on Phase III trial data, offers a chemotherapy-free option. According to Pfizer, this may delay disease progression and aid in personalized treatment plans. Tukysa was part of Pfizer's acquisition of Seagen in 2023.

Pfizer's investigational drug tilrekimig (PF-07275315) achieved EASI-75 in up to 63% of biologic-naive adults with moderate to severe atopic dermatitis at week 16 in phase 2 trials, presented at EADV Congress 2026. The trispecific antibody targets IL-4, IL-13, and TSLP. Pfizer has moved the drug into phase 3 development, including a trial comparing it to dupilumab. The drug was well-tolerated with no dose-dependent safety signals.

Pfizer's Tukysa received FDA approval for earlier use in HER2-positive breast cancer. The drug, acquired via Pfizer's Seagen acquisition, is now approved for maintenance treatment in combination with other therapies. Pfizer hopes this will boost Tukysa's growth, which has lagged behind competitors like AstraZeneca's Enhertu. Analysts have upgraded Tukysa's peak sales projections to around $1.5 billion, up from $500 million.

The FDA approved Tukysa (tucatinib) with trastuzumab and pertuzumab as maintenance therapy for HER2-positive breast cancer. The approval follows a trial showing median disease control of 24.9 months with Tukysa vs. 16.3 months with placebo. Pfizer markets Tukysa, which is now approved for first-line use after induction therapy. The trial, sponsored by Seagen (a Pfizer subsidiary), enrolled 654 adults, with results presented at the San Antonio Breast Cancer Symposium in December 2025.

Pfizer (PFE) received FDA approval for TUKYSA in HER2+ metastatic breast cancer and presented new LITFULO data, boosting its oncology and immunology portfolio. The company's shares have risen 15.46% over 90 days and 11.20% year-to-date. Analysts estimate Pfizer is 3% undervalued, with a fair value of $28.88 compared to its $28.00 closing price.