Orphan Drugs: In Development

DISEASE
Cancer, Leukemia
(continued)

DRUG NAME
monoclonal
antibodies
(PM-81 and AML-2.23)

SPONSOR
Medarex
(Princeton, NJ)

FDA OFFICIAL DESIGNATION
for the exogenous depletion of
CD14 and CD15 positive acute
myeloid leukemia bone marrow cells
from patients undergoing bone
marrow transplantation

DEVELOPMENT
STATUS
Phase II

ONCOLYSIN B ImmunoGen treatment of B-cell leukemia and Phase II
anti-b4-blocked ricin (Cambridge, MA) B-cell lymphoma
ONCOLYSIN M ImmunoGen treatment of myeloid leukemia, Phase I/II
anti-my9-blocked (Cambridge, MA) including AML and blast crisis of CML
ricin
PEG-L-asparaginase Enzon treatment of acute lymphocytic application submitted
(S. Plainfield, NJ) leukemia
Veasnoid Hoffmann-La Roche treatment of acute promyelocytic Phase III
all-trans retinoic acid (Nutley, NJ) leukemia

VeeM-26
teniposide (VM-26)

Bristol-Myers Squibb
(New York, NY)

treatment of refractory childhood
acute lymphocytic leukemia (ALL)

application submitted

Cancer, Lung trimetrexate U.S. Bioscience treatment of advanced nonsmall cell Phase II
glucuronate (West Conshohocken, PA) carcinoma of the lung
ONCOLYSIN S ImmunoGen treatment of small cell lung cancer Phase I/II
N901-blocked ricin (Cambridge, MA)
Cancer, FludaraTM Berlex treatment and management of Phase I
Lymphoma fludarabine phosphate (Wayne, NJ) non-Hodgkin's lymphoma (NHL)
ImmuRAIT-LL2 Immunomedics (See Cancer, Leukemia)
iodine 131-intact IgG (Warren, NJ)
MAb
methotrexate with Whitby Research topical treatment of mycosis Phase II
laurocapram (Richmond, VA) fungoides
ONCOLYSIN B ImmunoGen (See Cancer, Leukemia)
anti-b4-blocked ricin (Cambridge, MA)
SPECIFIDTM IDEC Pharmaceuticals treatment of B-cell lymphoma Phase III
murine monoclonal (Mountain View, CA)
antibodies to human
B-cell lymphomas
(anti-idiotypes)
Sterecyt~ Kabi Pharmacia treatment of malignant Phase III
prednimustine (Piscataway, NJ) non-Hodgkin's lymphomas
Cancer, Alkeran~ for Burroughs Wellcome hyperthermic regional limb application submitted
Melanoma Injection (Rsch. Triangle Park, NC) perfusion to treat metastatic
melphalan melanoma of the extremity
EthyoTM U.S. Bioscience use as a chemoprotective agent for application submitted
amifostine (W. Conshohocken, PA) cisplatin in the treatment of
metastatic melanoma
MelacineTM Ribi ImmunoChem treatment of stage III-IV melanoma Phase III
melanoma vaccine (Hamilton, MT)
OncoTrac~ NeoRx for use in detecting, by imaging, application submitted
Melanoma (Seattle, WA) metastases of malignant melanoma
technetium Tc-99m
antimelanoma
murine MAb
XomaZyme~-Mel Xoma treatment of stage III melanoma not Phase II
antimelanoma (Berkeley, CA) amenable to surgical resection
immunotoxin
Cancer, Alkeran~ for Burroughs Wellcome treatment of patients with multiple application submitted
Multiple Myeloma Injection (Rsch. Triangle Park, NC) myeloma for whom oral therapy is
melphalan inappropriate
Cancer, Ovarian Decapeptyl~ Organon for use in the palliative treatment of Phase II

Injection
triptorelin pamoate
EthyoTM
amifostine

(West Orange, NJ)

advanced ovarian carcinoma of
epithelial origin

U.S. Bioscience
(W. Conshohocken, PA)

use as a chemoprotective agent for
cisplatin in the treatment of
advanced ovarian carcinoma

application submitted

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