Last reviewed 2026-06-01 · How we verify

Enoblituzumab Schedule 2

MacroGenics · Phase 1 active Biologic ✓ Verified Jun 2026 Quality 0/100

Enoblituzumab Schedule 2 is a Biologic drug developed by MacroGenics. It is currently in Phase 1 development. Also known as: MGA271.

Enoblituzumab Schedule 2 is being studied in combination with pembrolizumab for the treatment of refractory cancer, including melanoma, head and neck cancer, non small cell lung cancer, and urothelial carcinoma. The study is a phase 1, open-label, dose escalation study.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Enoblituzumab Schedule 2
Also known as	MGA271
Sponsor	MacroGenics
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

Enoblituzumab Schedule 2 CI brief — competitive landscape report
Enoblituzumab Schedule 2 updates RSS · CI watch RSS
MacroGenics portfolio CI

Frequently asked questions about Enoblituzumab Schedule 2

What is Enoblituzumab Schedule 2?

Enoblituzumab Schedule 2 is a Biologic drug developed by MacroGenics.

Who makes Enoblituzumab Schedule 2?

Enoblituzumab Schedule 2 is developed by MacroGenics (see full MacroGenics pipeline at /company/macrogenics).

Is Enoblituzumab Schedule 2 also known as anything else?

Enoblituzumab Schedule 2 is also known as MGA271.

What development phase is Enoblituzumab Schedule 2 in?

Enoblituzumab Schedule 2 is in Phase 1.

Manufacturer: MacroGenics — full pipeline
Also known as: MGA271

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