The amended protocol now allows additional treatment options in the control arm including Mylotarg
, Venetoclax, and the FLT3 inhibitors Midostaurin and Sorafenib.
M2 EQUITYBITES-April 25, 2018-EU approval for Pfizer's Mylotarg
as treatment for AML
M2 PHARMA-April 25, 2018-EU approval for Pfizer's Mylotarg
as treatment for AML
You could not get a better example than Pfizer's Mylotarg
which has recently come back on the market after it was withdrawn in 2010 after patient toxicity concerns.
To date, there are several FDA approved NPs such as Doxil (1995), Feridex (1996), Mylotarg
(2000), Zevalin (2002), Abraxane (2005, 2013), Oncospar (2006), and Ontac (2008) that utilize EPR effect to accumulate in solid tumors .
Patient Age Sex Disease type Mutation 1 49 F AML K700E 2 65 F AML K700E 3 25 M AML K700E 4 64 F AML K700E 5 50 M MDS K700E 6 70 F MDS K700E 7 76 F MDS K700E 8 77 M Lung V701F Patient Treatment 1 AcIVP-16, Aza, decitabine, CLAG-M 2 Azacitadine 3 Cytarabine/Idarubicin, AcIVP16, decitabine/ mylotarg
, CLAG-M, Aza/Len 4 AcIVP-16 5 Sotatercept 6 Len, Aza 7 Len, Decitabine, Sotatercept 8 carboplatin/pemetrexed, pemetrexed, now on nivolumab AcIVP-16: cytarabine, idarubicin, etoposide; CLAG-M: cladribine, cytarabine, mitoxantrone; Aza: azacitadine; Len: lenaldiomide.
Food and Drug Administration has approved MYLOTARG
(gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.1 MYLOTARG
is the first therapy with an indication that includes pediatric AML.
Jatoi et al., "Gemtuzumab ozogamicin (Mylotarg
) is infrequently associated with sinusoidal obstructive syndrome/veno-occlusive disease," Annals of Oncology, vol.
The first conjugate to be approved was Mylotarg
which was pulled from the market in 2010 by Pfizer Inc's after a study showed it did not extend survival for patients with myeloid leukemia, a bone marrow cancer.
Estey et al., "Antibody-targeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg
(gemtuzumab ozogamicin)," Leukemia, vol.
For example, Pfizer's leukemia drug Mylotarg
, which was sold in the US for 10 years, did not extend survival.