Page updated ·next FDA decision on the calendar·Data as of Oct 13, 2026 11:39 PM ET
✓ APPROVED
KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) was approved by the FDA for muscle-invasive bladder cancer (MIBC); the approval was announced on July 10, 2026.
PADCEV (enfortumab vedotin-ejfv) plus Keytruda approved as neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer, regardless of cisplatin eligibility (Jul 10 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (1/15/26) through T+3. Run-up high $28.55 on 4/1/26, low $23.67 on 6/25/26 (T-120 to T-1). FDA decision 7/10/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-07-10
OutcomeApproved
Drug / candidateKEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYNOTE-B15/EV-304)
IndicationMuscle-invasive bladder cancer (MIBC)
CompanyPfizer Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)-6.3%
Cohort decision-day move (history)1.0% median (n=837)
The PDUFA goal date was August 17, 2026 for the cisplatin-eligible population, based on the Phase 3 KEYNOTE-B15 trial (also known as EV-304). The FDA approved on July 10, 2026, about five weeks early. PADCEV is partnered between Pfizer and Astellas.
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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was KEYTRUDA (pembrolizumab) approved by the FDA?
Yes. The approval of the application for KEYTRUDA (pembrolizumab) was announced on July 10, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Which company is behind KEYTRUDA (pembrolizumab)?
KEYTRUDA (pembrolizumab) is a Pfizer Inc. (PFE) program. The company announced the FDA decision on July 10, 2026; the company's own announcement is linked on this page.
How did PFE stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), PFE moved -6.3%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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