Last reviewed 2026-04-23 · How we verify

Placebo PF00299804

Pfizer · Phase 3 active Small molecule

Placebo PF00299804 is a EGFR/HER2 tyrosine kinase inhibitor Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Non-small cell lung cancer (NSCLC), HER2-positive breast cancer. Also known as: PF-00299804.

PF00299804 is a small-molecule tyrosine kinase inhibitor that targets EGFR and HER2 to block cancer cell growth signaling.

Dacomitinib (PF-00299804) is a second-generation, irreversible EGFR tyrosine kinase inhibitor developed by Pfizer. It has completed several clinical trials in advanced non-small cell lung cancer (NSCLC), showing promise in patients who have not responded to standard therapy. Despite no FDA approval, it has been evaluated for its efficacy and safety in multiple phases of clinical development.

Likelihood of approval

64.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Big-pharma sponsor +3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Placebo PF00299804
Also known as	PF-00299804
Sponsor	Pfizer
Drug class	EGFR/HER2 tyrosine kinase inhibitor
Target	EGFR, HER2
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

PF00299804 irreversibly inhibits epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) tyrosine kinases. By blocking these key growth signaling pathways, it prevents proliferation of cancer cells that depend on EGFR/HER2 activation. This dual targeting approach is designed to overcome resistance mechanisms seen with single-target EGFR inhibitors.

Approved indications

Non-small cell lung cancer (NSCLC)
HER2-positive breast cancer

Common side effects

Diarrhea
Rash
Nausea
Fatigue
Vomiting

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Placebo PF00299804 CI brief — competitive landscape report
Placebo PF00299804 updates RSS · CI watch RSS
Pfizer portfolio CI

Frequently asked questions about Placebo PF00299804

What is Placebo PF00299804?

Placebo PF00299804 is a EGFR/HER2 tyrosine kinase inhibitor drug developed by Pfizer, indicated for Non-small cell lung cancer (NSCLC), HER2-positive breast cancer.

How does Placebo PF00299804 work?

PF00299804 is a small-molecule tyrosine kinase inhibitor that targets EGFR and HER2 to block cancer cell growth signaling.

What is Placebo PF00299804 used for?

Placebo PF00299804 is indicated for Non-small cell lung cancer (NSCLC), HER2-positive breast cancer.

Who makes Placebo PF00299804?

Placebo PF00299804 is developed by Pfizer (see full Pfizer pipeline at /company/pfizer).

Is Placebo PF00299804 also known as anything else?

Placebo PF00299804 is also known as PF-00299804.

What drug class is Placebo PF00299804 in?

Placebo PF00299804 belongs to the EGFR/HER2 tyrosine kinase inhibitor class. See all EGFR/HER2 tyrosine kinase inhibitor drugs at /class/egfr-her2-tyrosine-kinase-inhibitor.

What development phase is Placebo PF00299804 in?

Placebo PF00299804 is in Phase 3.

What are the side effects of Placebo PF00299804?

Common side effects of Placebo PF00299804 include Diarrhea, Rash, Nausea, Fatigue, Vomiting.

What does Placebo PF00299804 target?

Placebo PF00299804 targets EGFR, HER2 and is a EGFR/HER2 tyrosine kinase inhibitor.

Drug class: All EGFR/HER2 tyrosine kinase inhibitor drugs
Target: All drugs targeting EGFR, HER2
Manufacturer: Pfizer — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer (NSCLC)
Indication: Drugs for HER2-positive breast cancer
Also known as: PF-00299804

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing