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Mylotarg (gemtuzumab ozogamicin) Injection

Phase 2
PFIZER (PFE)

Phase 2

Development Phase

0

Upcoming Catalysts

0

Historical Events

2

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Acute Myelogenous Leukemia

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Drug Information

Target Indication

Acute Myelogenous Leukemia

Clinical Trial

NCT00044733

Last updated: 3/3/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMAPending

Mylotarg

re-induction treatment of CD33-positive AML adult patients in first relapse who are not candidates for other intensive re-induction chemotherapy regimens (e.g. high-dose Ara-C) and meet at least one of the following criteria: duration of first remission 60 years.

Orphan
View on EMA
EMA4/19/2018

Mylotarg

Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).

Orphan
View on EMA
Drug Science
Mechanism of action & safety profile
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