|
APPROVED ONCOLOGY DRUGS (FDA Center for Drug
Evaluation and Research) |
|
Drug Name |
Brand Name |
Indication |
| Alemtuzumab |
Campath |
Accel. Approv. (clinical benefit not
established) Campath is indicated for the treatment of B-cell chronic
lymphocytic leukemia (B-CLL) in patients who have been treated with
alkylating agents and who have failed fludarabine therapy. |
| alitretinoin |
Panretin |
Topical treatment of cutaneous lesions
in patients with AIDS-related Kaposi's sarcoma. |
| allopurinol |
Zyloprim |
Patients with leukemia, lymphoma and
solid tumor malignancies who are receiving cancer therapy which causes
elevations of serum and urinary uric acid levels and who cannot tolerate
oral therapy. |
| altretamine |
Hexalen |
Single agent palliative treatment
of patients with persistent or recurrent ovarian cancer following first-line
therapy with a cisplatin and/or alkylating agent based combination. |
| amifostine |
Ethyol |
To reduce the cumulative renal toxicity
associated with repeated administration of cisplatin in patients with
advanced ovarian cancer |
| amifostine |
Ethyol |
Accel. Approv. (clinical benefit not
established) Reduction of platinum toxicity in non-small cell lung
cancer |
| amifostine |
Ethyol |
To reduce post-radiation xerostomia
for head and neck cancer where the radiation port includes a substantial
portion of the parotid glands. |
| anastrozole |
Arimidex |
Accel. Approv. (clinical benefit not
established) for the adjuvant treatment of postmenopausal women with
hormone receptor positive early breast cancer |
| anastrozole |
Arimidex |
Treatment of advanced breast cancer
in postmenopausal women with disease progression following tamoxifen
therapy. |
| anastrozole |
Arimidex |
For first-line treatment of postmenopausal
women with hormone receptor positive or hormone receptor unknown locally
advanced or metastatic breast cancer. |
| arsenic
trioxide |
Trisenox |
Second line treatment of relapsed
or refractory APL following ATRA plus an anthracycline. |
| Asparaginase |
Elspar |
ELSPAR is indicated in the therapy
of patients with acute lymphocytic leukemia. This agent is useful primarily
in combination with other chemotherapeutic agents in the induction
of remissions of the disease in pediatric patients. |
| BCG
Live |
TICE
BCG |
|
| bexarotene
capsules |
Targretin |
For the treatment by oral capsule
of cutaneous manifestations of cutaneous T-cell lymphoma in patients
who are refractory to at least one prior systemic therapy. |
| bexarotene
gel |
Targretin |
For the topical treatment of cutaneous
manifestations of cutaneous T-cell lymphoma in patients who are refractory
to at least one prior systemic therapy. |
| bleomycin |
Blenoxane |
|
| bleomycin |
Blenoxane |
Sclerosing agent for the treatment
of malignant pleural effusion (MPE) and prevention of recurrent pleural
effusions. |
| busulfan
intravenous |
Busulfex |
Use in combination with cyclophoshamide
as conditioning regimen prior to allogeneic hematopoietic progenitor
cell transplantation for chronic myelogenous leukemia. |
| busulfan
oral |
Myleran |
Chronic Myelogenous Leukemia- palliative
therapy |
| calusterone |
Methosarb |
|
| capecitabine |
Xeloda |
Accel. Approv. (clinical benefit subsequently
established) Treatment of 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 |
| capecitabine |
Xeloda |
Initial therapy of patients with metastatic
colorectal carcinoma when treatment with fluoropyrimidine therapy alone
is preferred. Combination chemotherapy has shown a survival benefit
compared to 5-FU/LV alone. A survival benefit over 5_FU/LV has not
been demonstrated with Xeloda monotherapy. |
| capecitabine |
Xeloda |
Treatment in combination with docetaxel
of patients with metastatic breast cancer after failure of prior anthracycline
containing chemotherapy |
| carboplatin |
Paraplatin |
Palliative treatment of patients with
ovarian carcinoma recurrent after prior chemotherapy, including patients
who have been previously treated with cisplatin. |
| carboplatin |
Paraplatin |
Initial chemotherapy of advanced ovarian
carcinoma in combination with other approved chemotherapeutic agents. |
| carmustine |
BCNU,
BiCNU |
|
| carmustine
with Polifeprosan 20 Implant |
Gliadel
Wafer |
For use in addition to surgery to
prolong survival in patients with recurrent glioblastoma multiforme
who qualify for surgery. |
| celecoxib |
Celebrex |
Accel. Approv. (clinical benefit not
established) Reduction of polyp number in patients with the rare genetic
disorder of familial adenomatous polyposis. |
| chlorambucil |
Leukeran |
Chronic Lymphocytic Leukemia- palliative
therapy |
| chlorambucil |
Leukeran |
|
| cisplatin |
Platinol |
Metastatic testicular-in established
combination therapy with other approved chemotherapeutic agents in
patients with metastatic testicular tumors whoc have already received
appropriate surgical and/or radiotherapeutic procedures. An established
combination therapy consists of Platinol, Blenoxane and Velbam. |
| cisplatin |
Platinol |
Metastatic ovarian tumors - in established
combination therapy with other approved chemotherapeutic agents: Ovarian-in
established combination therapy with other approved chemotherapeutic
agents in patients with metastatic ovarian tumors who have already
received appropriate surgical and/or radiotherapeutic procedures. An
established combination consists of Platinol and Adriamycin. Platinol,
as a single agent, is indicated as secondary therapy in patients with
metastatic ovarian tumors refractory to standard chemotherapy who have
not previously received Platinol therapy. |
| cisplatin |
Platinol |
as a single agent for patients with
transitional cell bladder cancer which is no longer amenable to local
treatments such as surgery and/or radiotherapy. |
| cladribine |
Leustatin,
2-CdA |
Treatment of active hairy cell leukemia. |
| cyclophosphamide |
Cytoxan,
Neosar |
|
| dacarbazine |
DTIC-Dome |
|
| dactinomycin,
actinomycin D |
Cosmegen |
|
| Darbepoetin
alfa |
Aranesp |
Treatment of anemia associated with
chronic renal failure. |
| Darbepoetin
alfa |
Aranesp |
Aranesp is indicated for the treatment
of anemia in patients with non- myeloid malignancies where anemia is
due to the effect of concomitantly administered chemotherapy. |
| daunorubicin
liposomal |
DanuoXome |
First line cytotoxic therapy for advanced,
HIV related Kaposi's sarcoma. |
| daunorubicin,
daunomycin |
Daunorubicin |
Leukemia/myelogenous/monocytic/erythroid
of adults/remission induction in acute lymphocytic leukemia of children
and adults. |
| daunorubicin,
daunomycin |
Cerubidine |
In combination with approved anticancer
drugs for induction of remission in adult ALL. |
| Denileukin
diftitox |
Ontak |
Accel. Approv. (clinical benefit not
established) treatment of patients with persistent or recurrent cutaneous
T-cell lymphoma whose malignant cells express the CD25 component of
the IL-2 receptor |
| dexrazoxane |
Zinecard |
Accel. Approv. (clinical benefit subsequently
established) Prevention of cardiomyopathy associated with doxorubicin
administration |
| dexrazoxane |
Zinecard |
reducing the incidence and severity
of cardiomyopathy associated with doxorubicin administration in women
with metastatic breast cancer who have received a cumulative doxorubicin
dose of 300 mg/m2 and who will continue to receive doxorubicin therapy
to maintain tumor control. It is not recommended for use with the initiation
of doxorubicin therapy. |
| docetaxel |
Taxotere |
Accel. Approv. (clinical benefit subsequently
established) Treatment of patients with locally advanced or metastatic
breast cancer who have progressed during anthracycline-based therapy
or have relapsed during anthracycline-based adjuvant therapy. |
| docetaxel |
Taxotere |
For the treatment of locally advanced
or metastatic breast cancer which has progressed during anthracycline-based
treatment or relapsed during anthracycline-based adjuvant therapy. |
| docetaxel |
Taxotere |
For locally advanced or metastatic
non-small cell lung cancer after failure of prior platinum-based chemotherapy. |
| docetaxel |
Taxotere |
in combination with cisplatin for
the treatment of patients with unresectable, locally advanced or metastatic
non-small cell lung cancer who have not previously received chemotherapy
for this condition. |
| doxorubicin |
Adriamycin
PFS Injectionintravenous injection |
Antibiotic, antitumor agent. |
| doxorubicin
liposomal |
Doxil |
Accel. Approv. (clinical benefit not
established) Treatment of AIDS-related Kaposi's sarcoma in patients
with disease that has progressed on prior combination chemotherapy
or in patients who are intolerant to such therapy. |
| doxorubicin
liposomal |
Doxil |
Accel. Approv. (clinical benefit not
established) Treatment of metastatic carcinoma of the ovary in patient
with disease that is refractory to both paclitaxel and platinum based
regimens |
| Elliott's
B Solution |
Elliott's
B Solution |
Diluent for the intrathecal administration
of methotrexate sodium and cytarabine for the prevention or treatment
of meningeal leukemia or lymphocytic lymphoma. |
| epirubicin |
Ellence |
A component of adjuvant therapy in
patients with evidence of axillary node tumor involvement following
resection of primary breast cancer. |
| Epoetin
alfa |
epogen |
EPOGENB is indicated for the reatment
of anemia related to therapy with zidovudine in HIV- infected patients.
EPOGENB is indicated to elevate or maintain the red blood cell level
(as manifested by the hematocrit or hemoglobin determinations) and
to decrease the need for transfusions in these patients. EPOGEND is
not indicated for the treatment of anemia in HIV-infected patients
due to other factors such as iron or folate deficiencies, hemolysis
or gastrointestinal bleeding, which should be managed appropriately. |
| Epoetin
alfa |
epogen |
EPOGENB is indicated for the treatment
of anemic patients (hemoglobin > 10 to _< 13 g/dL) scheduled
to undergo elective, noncardiac, nonvascular surgery to reduce the
need for allogeneic blood transfusions. |
| Epoetin
alfa |
epogen |
EPOGENB is indicated for the treatment
of anemia in patients with non-myeloid malignancies where anemia is
due to the effect of concomitantly administered chemotherapy. EPOGEND
is indicated to decrease the need for transfusions in patients who
will be receiving concomitant chemotherapy for a minimum of 2 months.
EPOGENB is not indicated for the treatment of anemia in cancer patients
due to other factors such as iron or folate deficiencies, hemolysis
or gastrointestinal bleeding, which should be managed appropriately. |
| Epoetin
alfa |
epogen |
EPOGEN is indicated for the treatment
of anemia associated with CRF, including patients on dialysis (ESRD)
and patients not on dialysis. |
| estramustine |
Emcyt |
palliation of prostate cancer |
| etoposide
phosphate |
Etopophos |
Management of refractory testicular
tumors, in combination with other approved chemotherapeutic agents. |
| etoposide
phosphate |
Etopophos |
Management of small cell lung cancer,
first-line, in combination with other approved chemotherapeutic agents. |
| etoposide
phosphate |
Etopophos |
Management of refractory testicular
tumors and small cell lung cancer. |
| etoposide,
VP-16 |
Vepesid |
Refractory testicular tumors-in combination
therapy with other approved chemotherapeutic agents in patients with
refractory testicular tumors who have already received appropriate
surgical, chemotherapeutic and radiotherapeutic therapy. |
| etoposide,
VP-16 |
VePesid |
In combination with other approved
chemotherapeutic agents as first line treatment in patients with small
cell lung cancer. |
| etoposide,
VP-16 |
Vepesid |
In combination with other approved
chemotherapeutic agents as first line treatment in patients with small
cell lung cancer. |
| exemestane |
Aromasin |
Treatment of advance breast cancer
in postmenopausal women whose disease has progressed following tamoxifen
therapy. |
| Filgrastim |
Neupogen |
NEUPOGEN is indicated to reduce the
duration of neutropenia and neutropenia-related clinical sequelae,
eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing
myeloablative chemotherapy followed by marrow transplantation. |
| Filgrastim |
Neupogen |
NEUPOGEN is indicated to decrease
the incidence of infection, as manifested by febrile neutropenia, in
patients with nonmyeloid malignancies receiving myelosuppressive anticancer
drugs associated with a significant incidence of severe neutropenia
with fever. |
| Filgrastim |
Neupogen |
NEUPOGEN is indicated for reducing
the time to neutrophil recovery and the duration of fever, following
induction or consolidation hemotherapy treatment of adults with AML. |
| floxuridine
(intraarterial) |
FUDR |
|
| fludarabine |
Fludara |
Palliative treatment of patients with
B-cell lymphocytic leukemia (CLL) who have not responded or have progressed
during treatment with at least one standard alkylating agent containing
regimen. |
| fluorouracil,
5-FU |
Adrucil |
prolong survival in combination with
leucovorin |
| fulvestrant |
Faslodex |
the treatment of hormone receptor-positive
metastatic breast cancer in postmenopausal women with disease progression
following antiestrogen therapy |
| gemcitabine |
Gemzar |
Treatment of patients with locally
advanced (nonresectable stage II or III) or metastatic (stage IV) adenocarcinoma
of the pancreas. Indicated for first-line treatment and for patients
previously treated with a 5-fluorouracil-containing regimen. |
| gemcitabine |
Gemzar |
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 lung cancer. |
| gemtuzumab
ozogamicin |
Mylotarg |
Accel. Approv. (clinical benefit not
established) Treatment of CD33 positive acute myeloid leukemia in patients
in first relapse who are 60 years of age or older and who are not considered
candidates for cytotoxic chemotherapy. |
| goserelin
acetate |
Zoladex
Implant |
Palliative treatment of advanced breast
cancer in pre- and perimenopausal women. |
| hydroxyurea |
Hydrea |
Decrease need for transfusions in
sickle cell anemia |
| Ibritumomab
Tiuxetan |
Zevalin |
Accel. Approv. (clinical benefit not
established) treatment of patients with relapsed or refractory low-grade,
follicular, or transformed B-cell non-Hodgkin's lymphoma, including
patients with Rituximab refractory follicular non-Hodgkin's lymphoma. |
| idarubicin |
Idamycin |
For use in combination with other
approved antileukemic drugs for the treatment of acute myeloid leukemia
(AML) in adults. |
| idarubicin |
Idamycin |
In combination with other approved
antileukemic drugs for the treatment of acute non-lymphocytic leukemia
in adults. |
| ifosfamide |
IFEX |
Third line chemotherapy of germ cell
testicular cancer when used in combination with certain other approved
antineoplastic agents. |
| imatinib
mesylate |
Gleevec |
Accel. Approv. (clinical benefit not
established) Initial therapy of chronic myelogenous leukemia |
| imatinib
mesylate |
Gleevec |
Accel. Approv. (clinical benefit not
established) metastatic or unresectable malignant gastrointestinal
stromal tumors |
| imatinib
mesylate |
Gleevec |
Accel. Approv. (clinical benefit not
established) Initial treatment of newly diagnosed Ph+ chronic myelogenous
leukemia (CML). |
| Interferon
alfa-2b |
Intron
A |
Interferon alfa-2b, recombinant for
injection is indicated as adjuvant to surgical treatment in patients
18 years of age or older with malignant melanoma who are free of disease
but at high risk for systemic recurrence within 56 days of surgery. |
| Interferon
alfa-2b |
Intron
A |
Interferon alfa-2b, recombinant for
Injection is indicated for the initial treatment of clinically aggressive
follicular Non-Hodgkin's Lymphoma in conjunction with anthracycline-containing
combination chemotherapy in patients 18 years of age or older. |
| Interferon
alfa-2b |
Intron
A |
Interferon alfa-2b, recombinant for
Injection is indicated for intralesional treatment of selected patients
18 years of age or older with condylomata acuminata involving external
surfaces of the genital and perianal areas. |
| Interferon
alfa-2b |
Intron
A |
Interferon alfa-2b, recombinant for
Injection is indicated for the treatment of chronic hepatitis C in
patients 18 years of age or older with compensated liver disease who
have a history of blood or blood-product exposure and/or are HCV antibody
positive. |
| Interferon
alfa-2b |
Intron
A |
Interferon alfa-2b, recombinant for
Injection is indicated for the treatment of chronic hepatitis B in
patients 18 years of age or older with compensated liver disease and
HBV replication. |
| Interferon
alfa-2b |
Intron
A |
Interferon alfa-2b, recombinant for
Injection is indicated for the treatment of patients 18 years of age
or older with hairy cell leukemia. |
| Interferon
alfa-2b |
Intron
A |
Interferon alfa-2b, recombinant for
Injection is indicated for the treatment of selected patients 18 years
of age or older with AIDS-Related Kaposi's Sarcoma. The likelihood
of response to INTRON A therapy is greater in patients who are without
systemic symptoms, who have limited lymphadenopathy and who have a
relatively intact immune system as indicated by total CD4 count. |
| irinotecan |
Camptosar |
Accel. Approv. (clinical benefit subsequently
established) Treatment of patients with metastatic carcinoma of the
colon or rectum whose disease has recurred or progressed following
5-FU-based therapy. |
| irinotecan |
Camptosar |
Follow up of treatment of metastatic
carcinoma of the colon or rectum whose disease has recurred or progressed
following 5-FU-based therapy. |
| irinotecan |
Camptosar |
For first line treatment n combination
with 5-FU/leucovorin of metastatic carcinoma of the colon or rectum. |
| letrozole |
Femara |
Treatment of advanced breast cancer
in postmenopausal women. |
| letrozole |
Femara |
First-line treatment of postmenopausal
women with hormone receptor positive or hormone receptor unknown locally
advanced or metastatic breast cancer. |
| leucovorin |
Wellcovorin,
Leucovorin |
Leucovorin calcium is indicated fro
use in combination with 5-fluorouracil to prolong survival in the palliative
treatment of patients with advanced colorectal cancer. |
| leucovorin |
Leucovorin |
In combination with fluorouracil to
prolong survival in the palliative treatment of patients with advanced
colorectal cancer. |
| levamisole |
Ergamisol |
Adjuvant treatment in combination
with 5-fluorouracil after surgical resection in patients with Dukes'
Stage C colon cancer. |
| lomustine,
CCNU |
CeeBU |
|
| meclorethamine,
nitrogen mustard |
Mustargen |
|
| megestrol
acetate |
Megace |
|
| melphalan,
L-PAM |
Alkeran |
|
| melphalan,
L-PAM |
Alkeran |
Systemic administration for palliative
treatment of patients with multiple myeloma for whom oral therapy is
not appropriate. |
| mercaptopurine,
6-MP |
Purinethol |
|
| mesna |
Mesnex |
Prevention of ifosfamide-induced hemorrhagic
cystitis |
| methotrexate |
Methotrexate |
|
| methoxsalen |
Uvadex |
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. |
| mitomycin
C |
Mutamycin |
|
| mitomycin
C |
Mitozytrex |
therapy of disseminated adenocarcinoma
of the stomach or pancreas in proven combinations with other approved
chemotherapeutic agents and as palliative treatment when other modalities
have failed. |
| mitotane |
Lysodren |
|
| mitoxantrone |
Novantrone |
For use in combination with corticosteroids
as initial chemotherapy for the treatment of patients with pain related
to advanced hormone-refractory prostate cancer. |
| mitoxantrone |
Novantrone |
For use with other approved drugs
in the initial therapy for acute nonlymphocytic leukemia (ANLL) in
adults. |
| Oprelvekin |
Neumega |
Neumega is indicated for the prevention
of severe thrombocytopenia and the reduction of the need for platelet
transfusions following myelosuppressive chemotherapy in adult patients
with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. |
| oxaliplatin |
Eloxatin |
Accel. Approv. (clinical benefit not
established) in combination with infusional 5-FU/LV, is indicated for
the treatment of patients with metastatic carcinoma of the colon or
rectum whose disease has recurred or progressed during or within 6
months of completion of first line therapy with the combination of
bolus 5-FU/LV and irinotecan. |
| paclitaxel |
Paxene |
treatment of advanced AIDS-related
Kaposi's sarcoma after failure of first line or subsequent systemic
chemotherapy |
| paclitaxel |
Taxol |
Treatment of patients with metastatic
carcinoma of the ovary after failure of first-line or subsequent chemotherapy. |
| paclitaxel |
Taxol |
Treatment of breast cancer after failure
of combination chemotherapy for metastatic disease or relapse within
6 months of adjuvant chemotherapy. Prior therapy should have included
an anthracycline unless clinically contraindicated. |
| paclitaxel |
Taxol |
New dosing regimen for patients who
have failed initial or subsequent chemotherapy for metastatic carcinoma
of the ovary |
| paclitaxel |
Taxol |
second line therapy for AIDS related
Kaposi's sarcoma. |
| paclitaxel |
Taxol |
For first-line therapy for the treatment
of advanced carcinoma of the ovary in combination with cisplatin. |
| paclitaxel |
Taxol |
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. |
| paclitaxel |
Taxol |
For the adjuvant treatment of node-positive
breast cancer administered sequentially to standard doxorubicin-containing
combination therapy. |
| paclitaxel |
Taxol |
First line ovarian cancer with 3 hour
infusion. |
| pamidronate |
Aredia |
Treatment of osteolytic bone metastases
of breast cancer in conjunction with standard antineoplastic therapy. |
| pegademase |
Adagen
(Pegademase Bovine) |
Enzyme replacement therapy for patients
with severe combined immunodeficiency asa result of adenosine deaminase
deficiency. |
| Pegfilgrastim |
Neulasta |
Neulasta is indicated to decrease
the incidence of infection, as manifested by febrile neutropenia, in
patients with non-myeloid malignancies receiving myelosuppressive anti-cancer
drugs associated with a clinically significant incidence of febrile
neutropenia. |
| pentostatin |
Nipent |
Single agent treatment for adult patients
with alpha interferon refractory hairy cell leukemia. |
| pentostatin |
Nipent |
Single-agent treatment for untreated
hairy cell leukemia patients with active disease as defined by clinically
significant anemia, neutropenia, thrombocytopenia, or disease-related
symptoms. (Supplement for front -line therapy.) |
| porfimer
sodium |
Photofrin |
For use in photodynamic therapy (PDT)
for palliation of patients with completely obstructing esophageal cancer,
or patients with partially obstructing esophageal cancer who cannot
be satisfactorily treated with ND-YAG laser therapy. |
| porfimer
sodium |
Photofrin |
For use in photodynamic therapy for
treatment of microinvasive endobronchial nonsmall cell lung cancer
in patients for whom surgery and radiotherapy are not indicated. |
| porfimer
sodium |
Photofrin |
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). |
| procarbazine |
Matulane |
|
| quinacrine |
Atabrine |
|
| Rasburicase |
Elitek |
ELITEK is indicated for the initial
management of plasma uric acid levels in pediatric patients with leukemia,
lymphoma, and solid tumor malignancies who are receiving anti-cancer
therapy expected to result in tumor lysis and subsequent elevation
of plasma uric acid. |
| Rituximab |
Rituxan |
|
| Sargramostim |
Prokine |
|
| streptozocin |
Zanosar |
Antineoplastic agent. |
| talc |
Sclerosol |
For the prevention of the recurrence
of malignant pleural effusion in symptomatic patients. |
| tamoxifen |
Nolvadex |
|
| tamoxifen |
Nolvadex |
As a single agent to delay breast
cancer recurrence following total mastectomy and axillary dissection
in postmenopausal women with breast cancer (T1-3, N1, M0) |
| tamoxifen |
Nolvadex |
For use in premenopausal women with
metastatic breast cancer as an alternative to oophorectomy or ovarian
irradiation |
| tamoxifen |
Nolvadex |
For use in women with axillary node-negative
breast cancer adjuvant therapy. |
| tamoxifen |
Nolvadex |
Metastatic breast cancer in men. |
| tamoxifen |
Nolvadex |
Equal bioavailability of a 20 mg Nolvadex
tablet taken once a day to a 10 mg Nolvadex tablet taken twice a day. |
| tamoxifen |
Nolvadex |
to reduce the incidence of breast
cancer in women at high risk for breast cancer |
| tamoxifen |
Nolvadex |
In women with DCIS, following breast
surgery and radiation, Nolvadex is indicated to reduce the risk of
invasive breast cancer. |
| temozolomide |
Temodar |
Accel. Approv. (clinical benefit not
established) Treatment of adult patients with refractory anaplastic
astrocytoma, i.e., patients at first relapse with disease progression
on a nitrosourea and procarbazine containing regimen |
| teniposide,
VM-26 |
Vumon |
In combination with other approved
anticancer agents for induction therapy in patients with refractory
childhood acute lymphoblastic leukemia (all). |
| testolactone |
Teslac |
|
| testolactone |
Teslac |
|
| thioguanine,
6-TG |
Thioguanine |
|
| thiotepa |
Thioplex |
|
| thiotepa |
Thioplex |
|
| thiotepa |
Thioplex |
|
| topotecan |
Hycamtin |
Treatment of patients with metastatic
carcinoma of the ovary after failure of initial or subsequent chemotherapy. |
| topotecan |
Hycamtin |
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 |
| toremifene |
Fareston |
Treatment of advanced breast cancer
in postmenopausal women. |
| Tositumomab |
Bexxar |
Accel. Approv. (clinical benefit not
established) Treatment of patients with CD20 positive, follicular,
non-Hodgkin's lymphoma, with and without transformation, whose disease
is refractory to Rituximab and has relapsed following chemotherapy |
| Trastuzumab |
Herceptin |
HERCEPTIN as a single agent is indicated
for the treatment of patients with metastatic breast cancer whose tumors
overexpress the HER2 protein and who have received one or more chemotherapy
regimens for their metastatic disease. |
| Trastuzumab |
Herceptin |
Herceptin in combination with paclitaxel
is indicated for treatment of patients with metastatic breast cancer
whose tumors overexpress the HER-2 protein and had not received chemotherapy
for their metastatic disease |
| Trastuzumab |
Herceptin |
|
| Trastuzumab |
Herceptin |
|
| Trastuzumab |
Herceptin |
|
| tretinoin,
ATRA |
Vesanoid |
Induction of remission in patients
with acute promyelocytic leukemia (APL) who are refractory to or unable
to tolerate anthracycline based cytotoxic chemotherapeutic regimens. |
| Uracil
Mustard |
Uracil
Mustard Capsules |
|
| valrubicin |
Valstar |
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. |
| vinblastine |
Velban |
|
| vincristine |
Oncovin |
|
| vinorelbine |
Navelbine |
Single agent or in combination with
cisplatin for the first-line treatment of ambulatory patients with
unresectable, advanced non-small cell lung cancer (NSCLC). |
| vinorelbine |
Navelbine |
Navelbine is indicated as a single
agent or in combination with cisplatin for the first-line treatment
of ambulatory patients with unreseactable, advanced non-small cell
lung cancer (NSCLC). In patients with Stage IV NSCLC, Navelbine is
indicated as a single agent or in combination with cisplatin. In Stage
III NSCLC, Navelbine is indicated in combination with cisplatin. |
| zoledronate |
Zometa |
the treatment of patients with multiple
myeloma and patients with documented bone metastases from solid tumors,
in conjunction with standard antineoplastic therapy. Prostate cancer
should have progressed after treatment with at least one hormonal therapy |
