||Product Approvals For Cancer Indications:
February 2001 Through June 1996 Listed By Approval Date
- Femara (letrozole)
from Novartis Pharmaceuticals Company received additional approval on January 11,
2001 for first-line treatment of postmenopausal women with hormone receptor
positive or hormone receptor unknown locally advanced or metastatic breast cancer.(Approval
Letter, Package Insert)
- Trisenox (arsenic
trioxide) from Cell Therapeutics, Inc, received approval on september 25, 2000 for
induction of remission and consolidation in patients with acute promyelocytic leukemia
(APL) who are refractory to, or have relapsed from, retinoid and anthracycline
chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation
or PML/RAR-alpha gene expression.(Approval Letter, Package Insert)
- Arimidex (anastrozole) from AstraZeneca Pharmaceuticals, received
additional approval on September 1, 2000, for first-line treatment of
postmenopausal women with hormone receptor positive or hormone receptor unknown locally
advanced or metastatic breast cancer.(Approval Letter)
- Nolvadex (tamoxifen citrate) from AstraZeneca Pharmaceuticals, received
additional approval on June 29,2000 for use in women with DCIS, following breast
surgery and radiation, Nolvadex is indicated to reduce the risk of invasive breast cancer.(Approval
Letter, Package Insert)
- Taxol (paclitaxel) from Bristol-Myers Squibb Company, received
additional approval for the first-line and subsequent therapy for the treatment of
advanced carcinoma of the ovary. As first-line therapy, Taxol, is indicated in
combination with cisplatin. (Approval Letter, Package Insert)
- Trelstar Depot (triptorelin pamoate) for injectable suspension, from
Debio Recherche Pharmaceutique S.A., received approval on June 15, 2000 for the
palliative treatment of advanced prostate cancer. (Approval Letter, Package Insert)
- Fludeoxyglucose (F-18) injection from Downstate Clinical PET Center,
received approval on June 2, 2000 as an (a) Assessment of abnormal glucose
metabolism to assist in the evaluation of malignancy in patients with known or suspected
abnormalities found byother testing modalities, or in patients with an existing diagnosis
of cancer. (b) Assessment of patients with coronary artery disease and left ventricular
dysfunction, when used together with myocardial perfusion imaging, for the identification
of left ventricular myocardium with residual glucose metabolism and reversible loss of
systolic function. (Approval Letter,
- FocalSeal-L Surgical Sealant from Focal Inc., received approval on May
30, 2000 as a surgical sealant for use in lungs to seal air leaks following
removal of cancerous lung tumors. (More
- Mylotarg (gemtuzumab ozogamicin) for injection, from Wyeth-Ayerst
Research, recevied approval on May 17, 2000, for the treatment of patients with
CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and
who are not considered candidates for cytotoxic chemotherapy. (More Information)
- Camptosar (irinotecan hydrochloride) injection, from Pharmacia &
Upjohn, received additional approval on April 20, 2000, as a component of
first-line therapy in combination with 5-fluorouracil and leucovorin for patients with
metastatic carcinoma of the colon or rectum.
- Pacis (BCG,live), from BioChem Pharma Inc. received approval on March
9, 2000, for the treatment of carcinoma-in-situ (CIS) in the absence of associated
invasive cancer of the bladder.
- Viadur (leuprolide acetate implant), from Alza Corporation, received
additional approval on March 3, 2000 for palliative treatment of advanced prostate
cancer. The drug product is delivered through a titanium device that is
implanted in the upper arm, this is a new rout of administration for leuprolide acetate.
Targretin (bexarotene) capsules, from Ligand Pharmaceuticals Inc.,
received approval on December 29, 1999 for the treatment of cutaneous
manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one
prior systemic therapy.
from Aventis Pharmaceuticals, received approval on December 23, 1999 for the
treatment of non-small cell lung cancer that does not respond to cisplatin-based
from G.D. Searle & Co., received accelerated approval on December 23, 1999 to
reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis
(FAP), as an adjunct to unual care (e.g. endoscopic surveillance surgery). (Approval Letter, Approved Labeling)
(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. (Approval Letter, Labeling )
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.
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.
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.
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).
Isolex 300 and 300i Magnetic
Cell Selection System, Nexell Therapeutics, Inc., received approval on July
2, 1999, for processing autologous peripheral blood progenitor cell products to
obtain a CD34+ cell enriched population intended for hematopoietic reconstitution after
myeloablative therapy in patients with CD34 negative tumors.
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
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.( Labeling )
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. (Labeling)
(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.
( Labeling )
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.(Labeling)
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.
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.
Panretin (Alitretinoin) gel 0.1%, by Ligand Pharmaceuticals received
approval on February 2, 1999 for the topical treatment of cutaneous lesions in
patients with AIDS-related Kaposi's sarcoma. Approval Letter Approved Labeling
(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
Photofrin (porfimer sodium), by QLT Phototherapeutics,
Inc., received additional approval on December 22, 1998 for use in photodynamic
therapy (PDT) for reduction of obstruction and palliation of symptoms in patients with
completely or partially obstructing endobroncial nonsmall cell lung cancer (NSCLC).
hydrochloride) for injection, by SmithKline Beecham Pharmaceuticals received additional
approval on November 30, 1998 for the use of Hycamtin in the treatment of small
cell lung cancer sensitive disease after failure of first-line chemotherapy. In
clinical studies submitted to support approval, sensitive disease was defined as disease
responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3
study) or at least 90 days (in the phase 2 studies) after chemotherapy. (Labeling)
Sandostatin LARŪ Depot (octreotide acetate for injectable
suspension), by Novartis Pharmaceuticals, was approved on November 25, 1998 for
the reduction of growth hormone and IGF-1 in acromegaly, the suppression of severe
diarrhea and flushing associated with malignant carcinoid syndrome and for the treatment
of the profuse watery diarrhea associated with VIPoma (vasoactive intestinal peptide
tumor). ( Labeling )
citrate), flavored sugar lozenge on a stick, by Anesta Corporation received approval on
November 4, 1998 for management of chronic pain in cancer patients that are
experiencing breakthrough pain on their regular narcotic (opioid) therapy. ( Patient Package Insert)
citrate) by Zeneca Pharmaceuticals received additional approval on October 29, 1998 to
reduce the incidence of breast cancer in women at high risk for breast cancer.
hydrochlorise) by Pharmacia & Upjohn received additional approval on October 22, 1998 for
the treatment of patients with metastatic carcinoma of the colon or rectum whose disease
has recurred or progressed following 5-FU-based therapy.
intravenous injection by Genentech, Inc., received approval on September 25, 1998 for
use alone for certain patients who have tried chemotherapy with little success or as a
first-line treatment for metastatic disease when used in combination with paclitaxel
(trade name Taxol)(additional information)
Sterile Solution for Intravesical Instillation, 5 mL, Single-Use Vials (40 mg/mL) by
Anthra Pharmaceuticals received approval on September 25, 1998 for intravesical
therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for
whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
HCL) for injection by Eli Lilly & Co. received additional approval on August 26, 1998 for
use in combination with cisplatin for the first-line treatment of patients with
inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell
(goserelin acetate implant) by Zeneca Pharmaceuticals received additional approval on July
27, 1998 for use of 3.6 mg and 10.8 mg depots in combination with flutamide for
the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.
[New dosage and Administration]
Ceprate SC Stem Cell Concentration System, from CellPro Incorporated
received additional approval for processing peripheral blood progenitor cells to
obtain a CD34 positive cell enriched population which is intended for hematopoietic
support after myeloablative chemotherapy in patients with CD34 negative tumors.
Urowave Microwave Thermotherapy System by Dornier Medical Systems,
Inc., received approval on May 29, 1998 as a non-surgical treatment alternative to
transurethral resection of the prostate (TURP). To treat symptomatic benign
prostatic hyperplasia (BPH) in men withprostatic lengths between 30 mm and 55 mm.
Taxol (paclitaxel) injection by Bristol-Myers Squibb Pharmaceutical
Research Institute received additional approval on June 30, 1998 for use in
combination with cisplatin, for the first-line treatment of non-small cell lung cancer in
patients who are not candidates for potentially curative surgery and/or radiation therapy.
Taxotere (docetaxel) injection concentrate (20 mg and 80 mg) by
Rhone-Poulenc Rorer received additional approval on June 22, 1998 for the
treatment of patients with locally advanced or metastatic breast cancer after failure of
tablets by Hoffman-La Roche received accelerated approval on April 30, 1998 for
treatment of patients with metastatic breast cancer resistant to both paclitaxel and an
anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom
further anthracycline therapy may be contraindicated, e.g., patients who have received
cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents.
Taxol (paclitaxel) injection by Bristol-Myers Squibb Pharmaceutical
Research Institute received additional approval on April 9, 1998 for first-line
therapy for the treatment of advanced carcinoma of the ovary in combination with
Zoladex (goserelin acetate implant) by Zeneca Pharmaceuticals, Inc.,
received additional approval on April 9, 1998 for palliative treatment of advanced
carcinoma of the prostate. [New Route of Administration]
Neupogen (filgrastim) by Amgen, Inc. received additional
approval on April 2, 1998 for use in patients with acute myeloid leukemia.
Daunorubicin HCL (daunorubicin hydrochloride) by Bedford Laboratories,
Div. Ben Venue Laboratories, Inc., received approval on January 30, 1998, to
provide a new 5 mg/mL, 4 mL ready-to-use solution which can be immediately used in an IV
infusion without the possibility of reconstitution error. Daunorubicin
HCL's indication is for use in combination with other approved anticancer drugs for
remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid)
of adults and for remission induction in acute lymphocytic leukemia of children and
Proleukin (aldesleukin) sponsored by Chiron Corporation received an
additional indication on January 9, 1998, for treatment of adults with metastatic
melanoma and updated response data for metastatic renal cell carcinoma patients, as well
as revised package insert information.
Photofrin (porfimer sodium) sponsored by QLT
Phototherapeutics, Inc., received an additional indication on January 9, 1998, for
treatment in photodynamic therapy for treatment of microinvasive endobronchial nonsmall
cell lung cancer in patients for whom surgery and radiotherapy are not indicated.
Rituxan (rituximab) sponsored by Genentech, Inc.,
received approval on November 26, 1997, for the treatment of
patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's
Neumega (oprelvekin) sponsored by Genetics Institute,
Inc., received approval on November 25, 1997, for the prevention of severe
thrombocytopenia and the reduction of the need for platelet transfusion following
myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high
risk of severe thrombocytopenia.
Intron A (interferon alfa-2a) sponsored by Schering
Corp., received approval on November 6, 1997, for use in conjunction with
chemotherapy in patients with follicular lymphoma.
Zofran (ondanstron hydrochloride) sponsored by Glaxo
Wellcome Inc., received approval on October 31, 1997, for intramuscular
administration as an alternative to intravenous administration in the prevention of
postoperative nausea and vomiting (new route of administration.)
Anzemet (dolasetron mesylate Tablet) sponsored by
Hoechst Marion Roussel, Inc., received approval on September 11, 1997, for the
prevention of chemotherapy-induced nausea and vomiting, and prevention of postoperative
nausea and vomiting.
Anzemet (dolasetron mesylate Injectable) sponsored by
Hoechst Marion Roussel, Inc., received approval on September 11, 1997, for the
prevention of chemotherapy-induced emesis, prevention of postoperative nausea and
vomiting, and treatment of postoperative nausea and vomiting.
Taxol (paclitaxel) for Injection, sponsored by Bristol
Myers Squibb Co. Pharmaceutical Research Institute, received an additional indication on
August 4, 1997, for the second line treatment of AIDS-related Kaposis sarcoma. Taxol was
previously indicated, after failure of first-line or subsequent chemotherapy for the
treatment of metastatic carcinoma of the ovary, and for treatment of breast cancer after
failure of combination chemotherapy for metastatic disease or relapse within 6 months of
Femara (letrozole) Tablets, sponsored by Novartis
Pharmaceuticals Corporation, received approval on July 25, 1997, for the treatment of
advanced breast cancer in postmenopausal women.
Lupron Depot (leuprolide acetate) for Injection,
sponsored by TAP Holdings Incorporated, received an additional indication on May 30, 1997,
to help relieve the symptoms associated with advanced prostate cancer. Lupron was
previously indicated for management of endometriosis, preoperative hematologic improvement
of anemia caused by uterine leiomyomata, palliative treatment of advanced prostate cancer
and central precocious puberty.
Fareston (toremifene citrate) Tablets, sponsored by Orion
Corporation, received approval on May 29, 1997, for the treatment of metastatic breast
cancer in postmenopausal women with estrogen receptor positive or receptor unknown tumors.
Quadramet (samarium sm 153 edtmp) for Injection, sponsored
by Cytogen Corporation, received approval on March 28, 1997, for the relief of pain in
patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide
Zofran (ondansetron hydrochloride) Oral Solution,
sponsored by Glaxo Wellcome Incorporated, received approval on January 24, 1997, for
the prevention of chemotherapy, radiotherapy, and postoperative induced nausea and
vomiting. Zofran was previously available in oral tablet and injectable formulations.
Dostinex (cabergoline) Tablets, sponsored by Pharmacia
& Upjohn Company, received approval on December 23, 1996, for the treatment of
hyperprolactinemic disorders, either idiopathic (i.e. of unknown cause)
or due to pituitary adenomas.
Novantrone (mitoxantrone hydrochloride) for Injection,
sponsored by Immunex Corporation, received an additional indication on November 13, 1996, for
use in combination with corticosteroids as initial chemotherapy for the treatment of
patients with pain related to advanced hormone refractory prostate cancer. Novantrone
was previously indicated for use in combination with other approved drugs in the initial
therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes
myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.
Duraclon (clonidine hydrochloride) for Injection,
sponsored by Fujisawa USA Incorporated, was approved on October 2, 1996, for continuous
epidural administration (a type of injection) as additional therapy with
intraspinal opiates (pain medication injected into the spinal column) for the
treatment of severe pain in cancer patients that is not adequately relieved by opioid pain
Elliotts B Solution (calcium chloride, dextrose, magnesium
sulfate, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate,
dibasic) for Injection, sponsored by Orphan Medical Incorporated, was approved on
September 27, 1996, for use in mixing methotrexate sodium and/or cytarabine for
intrathecal administration (a type of injection) to prevent or
treat meningeal leukemia or lymphocytic lymphoma.
Gliadel (carmustine wafer) for Implantation, sponsored by
Guilford Pharmaceuticals Incorporated, was approved on September 23, 1996, for use in
addition to surgery to prolong survival in patients with recurrent glioblastoma multiforme
who qualify for surgery.
Nilandron (nilutamide) Tablets, sponsored by GH Besselaar
Associates Incorporated, was approved on September 19, 1996, for use in combination
with surgical castration for the treatment of stage D2 metastatic prostate cancer.
Aredia (pamidronate disodium) for Injection, sponsored by
Ciba Geigy Corporation Pharmaceuticals Division, received an additional indication on July
16, 1996, for the treatment of osteolytic bone metastases of breast cancer. Aredia
was previously indicated for hypercalcemia associated with malignancy, osteolytic bone
lesions of multiple myeloma, and Paget's disease of bone.
Camptosar (irinotecan HCL) sponsored by Pharmacia and
Upjohn, received accelerated approval on June 14, 1996, for treatment of
metastatic carcinoma of the colon or rectum which has progressed or recurred after
treatment with 5-fluorouracil (5FU).
Hycamtin (topotecan HCL), from SmithKline Beecham, received approval
on May 28, 1996 for the treatment of metastatic ovarian cancer after failure of
first line chemotherapy.
Zyloprim (allopurinol sodium) from Glaxo Wellcome, received approval
on May 17, 1996 for the management of patients with leukemia, lymphoma, and solid
tumor malignancies who are receiving cancer therapy which causes elevation of uric acid
levels and who cannot tolerate oral therapy.
Etopophos (etoposide phosphate) from Bristol-Myers Squibb, received
approval on May 17, 1996 for the management of small cell lung cancer, firstline
and refractory testicular tumors, in combination with other approved chemotherapeutic
Gemzar ( gemcitabine HCL), from Lilly, received approval on May 16,
1996 for first line treatment for locally advanced (nonresectable stage II or III)
or metastatic (stage IV) pancreatic cancer; second-line treatment for pancreatic cancer
previously treated with 5-fluorouracil.
Taxotere (docetaxel) from Rhone-Poulenc Rorer, received approval on
May 14, 1996 for the treatment of locally advanced or metastatic breast cancer
which has progressed during anthracycline-based treatment or relapsed during
anthracycline-based adjuvant therapy.
DaunoXome (daunorubicin citrate liposome) from NeXstar, received
approval on April 8, 1996 for the first line cytotoxic treatment of advanced
HIV-associated Kaposi's sarcoma.
Ethyol (amifostine), from Alza, received approval on March 15, 1996, for
chemoprotectant/ cisplatin non-small cell lung cancer (NSCLC).
Blenoxane (bleomycin sulfate), from Bristol-Myers Squibb, received
approval on February 20, 1996 as a sclerosing agent for the treatment of malignant
pleural effusion and prevention of recurrent pleural effusions.
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Editor: Susan K. Boyer, RN
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