Tukysa (tucatinib) FDA approval for HER2+ breast cancer maintenance: Oct 7, 2026

Tukysa (tucatinib) + trastuzumab + pertuzumab - HER2+ metastatic breast cancer maintenance (HER2CLIMB-05) was approved by the FDA on October 7, 2026 for maintenance treatment, in combination with trastuzumab and pertuzumab, of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction therapy.

The FDA approved Tukysa (tucatinib) in combination with trastuzumab and pertuzumab as maintenance treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction therapy on October 7, 2026 (NDA 213411, supplement 10). Pfizer announced the approval the same day.

Run-up into the decision (T-120 → T+5)

Key facts

The FDA's approval letter for NDA 213411 supplement 10 is dated October 7, 2026 (FDA approval letter); Drugs@FDA lists the supplement as received December 17, 2025. Pfizer's release of October 7, 2026 describes the approval as based on the Phase 3 HER2CLIMB-05 trial (Pfizer release). pdufa.bio did not hold a goal date for this supplement, so no early or late margin is computed.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: FDA approval letter, NDA 213411 supplement 10, October 7, 2026

FDA record of the action: the FDA approved on October 7, 2026, per NDA 213411 SUPPL-10 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.