Current FDA Approved Drugs for use in Oncology
- Levulan Kerastick (aminolevulinic
acid HCL) for Topical Solution, 20%, received
approval on December 3, 1999 to be used in conjunction
with photodyamic therapy for treatment of actinic
keratoses (AKs) (pre-cancerous skin lesiions) of the
face or scalp. This is the first combined drug and
device treatment designed for targeted treatment that
can be limited just to the lesion site(s).
Aminolevulinic acid HCL is marketed by DUSA
Pharmaceuticals, Inc. of Valhalla, NY and will be
marketed under the trade number Levulan Kerastick for
Topical solution, 20%. It is to be marketed in
combination with the light source BLU-U Blue Light
Photodynamic Therapy Illuminator.
-
Taxol (paclitaxel) injection, from
Bristol-Myers Squibb, received additional approval on
October 25, 1999 for adjuvant treatment of
node-positive breast cancer administered sequentially
to standard doxorubicin-containing combination
chemotherapy. In the clinical trial, there was an
overall favorable effect on disease-free and overall
survival in the total population of patients with
receptor-positive and receptor-negative tumors, but
the benefit has been specifically demonstrated by
available data (median follow up 30 months) only in
the patients with estrogen and progesterone receptor
negative tumors.
- Aromasin (exemestane) Tablets,
from Pharmacia & Upjohn Company, received approval on
October 21, 1999 for the treatment of advance breast
cancer in postmenopausal women whose disease has
progressed following tamoxifen therapy.
- Ellence (epirubicin
hydrochloride), from Pharmacic & Upjohn received
approval on September 15, 1999 for use as a component
of adjuvant therapy in patients with evidence of
axillary node tumor involvement following resection of
primary breast cancer.
- Zofran (ondansetron), from Glaxo
Wellcome received additional approval on August 27,
1999 for the prevention of nausea and vomiting
associated with highly emetogenic cancer chemotherapy,
including cisplatin.
- Temodar (temozolomide), from
Schering-Plough Corporation received accelerated
approval on August 11, 1999 for the treatment of adult
patients with refractory anaplastic astrocytoma, (i.e.
patients at first relapse who have experienced disease
progression on a drug regimen containing a
nitgrosourea and procarbazine).
- Kytril (granisetron), from
SmithKline Beecham, received additional approval on
June 27, 1999 for the prevention of nausea and
vomiting associated with radiation, including total
body irradiation (TBI) and fractionated abdominal
radiation.
- Doxil (doxorubicin HCL liposome
injection), from Alza Corporation, received
accelerated approval on June 28, 1999 for a
supplemental indication for the treatment of
metastatic carcinoma of the ovary in patients with
disease that is refractory to both paclitaxel- and
platinum-based chemotherapy regimens. Refractory
disease is defined as disease that has progressed
while on treatment, or within 6 months of completing
treatment.
- Ethyol (amifostine) for
Injection, by US Bioscience, received additional
approval on June 24, 1999 to reduce the incidence of
moderate to severe xerostomia in patients undergoing
post-operative radiation treatment for head and neck
cancer, where the radiation port includes a
substantial portion of the parotid glands. Ethyol is
also marketed by Alza Pharmaceuticals.
- DepoCyt (cytarabine liposomal
injection, 10 mg/mL), by DepoTech Corporation,
received accelerated approval on April 1, 1999 for the
intrathecal treatment of lymphomatous meningitis.
This indication is based on demonstration of increased
complete response rate compared to unencapsulated
cytarabine. There are no controlled trials that
demonstrate a clinical benefit resulting from this
treatment, such as improvement in disease-related
symptoms, or increased time to disease progression, or
increased survival.
- UVADEX (methoxsalen sterile
solution, 20 mcg/mL), by Therakos, Inc. received
approval on February 25, 1999 for the use of UVADEX
with the UVAR Photopheresis System in the palliative
treatment of the skin manifestations of cutaneous
T-cell lymphoma (CTCL) that is unresponsive to other
forms of treatment.
- Ontak denileukin diftitox,
marketed by Ligand Pharmaceuticals and manufactured by
Seragen, Inc., received accelerated approval (based on
tumor reduction) on February 5, 1999 for the treatment
of persistent or recurrent cutaneous t-cell lymphoma,
(CTCL), a rare slow-growing form of non-Hodgkin's
lymphoma, whose malignant cells express the CD25
component of the IL-2 receptor.
- Busulfex (busulfan), by Orphan
Medical Inc received approval on February 4, 1999 for
use in combination with cyclophosphamide as a
conditioning regiment prior to allogeneic
hematopoietic progenitor cell transplantation for
chronic myelogenous leukemia.
- Zofran ODT (odansetron) orally
disintegrating tablets, by Glaxo Wellcome, Inc.,
received additional approval on January 27, 1999 for
prevention of chemotherapy and radiation-induced
nausea and vomiting, and prevention of postoperative
nausea and vomiting (new dosage form).
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