1
CURE FALL 2005
Clolar (clofarabine)
Femara (letrozole)
Erbitux (cetuximab)
Alimta (pemetrexed)
Iressa (gefitinib)
Bexxar (tositumomab)
Gleevec (imatinib)
Velcade (bortezomib)
Arimidex (anastrozole)
Eloxatin (oxaliplatin)
Zevalin (ibritumomab)
Campath (alemtuzumab)
Mylotarg (gemtuzumab)
Celebrex (celecoxib)
Temodar (temozolomide)
Doxil (doxorubicin)
DepoCyt (cytarabine)
Ontak (denileukin diftitox)
Xeloda (capecitabine)
Camptosar (irinotecan)
Taxotere (docetaxel)
Ethyol (amifostine)
Zinecard (dexrazoxane)
Pediatric relapsed or refractory acute lymphoblastic leukemia
Adjuvant treatment of early breast cancer in postmenopausal women
Metastatic colorectal cancer
Locally advanced or metastatic non-small-cell lung cancer
Third-line non-small-cell lung cancer [new labeling in June 2005 limits
Iressa use to clinical trial subjects or those benefiting from the drug]
Relapsed or refractory non-Hodgkin's lymphoma
Pediatric chronic myelogenous leukemia
Newly diagnosed CML
Metastatic or unresectable gastrointestinal stromal tumors
CML after interferon therapy
Multiple myeloma
Adjuvant treatment for hormone receptor-positive early breast cancer in
postmenopausal women
Second-line colorectal cancer
Relapsed or refractory follicular non-Hodgkin's lymphoma
Third-line B-cell chronic lymphocytic leukemia
Second-line acute myelogenous leukemia for patients 60 or older
Reduction of polyps in patients with familial adenomatous polyposis, a
genetic disorder that puts a person at high risk for colorectal cancer
Refractory anaplastic astrocytoma
Refractory ovarian cancer
Second-line Kaposi's sarcoma
Lymphomatous meningitis
Relapsed or refractory cutaneous T-cell lymphoma
Refractory breast cancer
Second-line colon cancer
Second-line breast cancer
Reduction of cisplatin toxicity in non-small-cell lung cancer
Prevention of heart disease associated with doxorubicin
2004
2004
2004
2004
2003
2003
2003
2002
2002
2001/2003
2003/2005
2002/2005
2002/2004
2002
2001
2000
1999
1999/2005
1999/2005
1995
1999
1999
1998/2001
1996/1998
1996/1998
1996
1995/2002
No additional indication to date
Approved in 1997 for treatment of advanced breast cancer in women
whose cancer had not responded to anti-estrogen drugs; approved in
2001 for newly diagnosed postmenopausal women with hormone
receptor-postive/unknown locally advanced or metastatic breast cancer
No additional indication to date
Approved in early 2004 for use in combination with cisplatin for
malignant pleural mesothelioma
No additional indication to date
No additional indication to date
No additional indication to date
No additional indication to date
Initially approved in 1996 for metastatic breast cancer refractory to
tamoxifen and later in 2000 for first-line treatment of postmenopausal
women with hormone receptor-positive/unknown locally advanced or
metastatic breast cancer
Approved in early 2004 for first-line therapy for metastatic colorectal
cancer; approved in late 2004 for adjuvant stage III colon cancer
treatment
No additional indication to date
No additional indication to date
No additional indication to date
Approved in 2005 for relief of signs and symptoms associated with
ankylosing spondylitis; approved in 2001 for acute pain in adults and
treatment of primary dysmenorrhea (painful menstrual cramps);
approved in 1998 for signs and symptoms of rheumatoid arthritis and
osteoarthritis
Approved in 2005 for glioblastoma multiforme
No additional indication to date
No additional indication to date
No additional indication to date
Approved in 2005 for advanced colon cancer
Approved in 2000 for newly diagnosed metastatic colon cancer
Approved in 1999 for cisplatin-refractory non-small-cell lung cancer;
approved in 2002 for unresectable locally advanced and metastatic
non-small-cell lung cancer; approved in 2004 for metastatic prostate
cancer
Approved in 1995 for cisplatin toxicity in advanced ovarian cancer;
approved in 1999 for radiation-induced xerostomia
No additional indication to date
YEAR OF
ACCELERATED
APPROVAL/FULL
APPROVAL
>
ADDITIONAL INDICATION
>
Accelerated Cancer Drugs
Currently, 24 oncology-related drugs have received accelerated approval from the FDA. Although only a handful of these drugs have gone on to
receive full approval, the FDA says drug companies must be allowed time to do phase III trials, which can take three years on average.
DRUG
>
ACCELERATED APPROVAL INDICATION
>
SOURCE: FDA
search
