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2006
- On December 8, FDA granted approval to bortezomib (Velcade), a proteasome inhibitor, for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. More information
- On November 16, FDA approved the expanded use of trastuzumab (Herceptin) for early stage breast cancer after primary therapy. More information
- On October 19, FDA approved imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indications. More information
- On October 17, FDA approved docetaxel (Taxotere) for use in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck. More information
- On October 11, FDA approved bevacizumab (Avastin) as a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer in combination with platinum-based chemotherapy. More information
- On October 6, FDA granted approval to vorinostat (Zolinza), a histone deacetylase inhibitor, for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease on or following two systemic therapies. More information
- On September 29, FDA approved two rituximab (Rituxan) supplemental applications for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma. More information
- On September 27, FDA approved imatinib mesylate (Gleevec) as a single agent for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML). More information
- On September 27, FDA approved panitumumab (vectibix) to treat metastatic colorectal carcinoma. More Information. More information
- On September 21, FDA approved changed in the Avastin package insert regarding warning and dose and administration for Reversible Posterior Leukoencephalopathy Syndrome. Nasal septum perforation was also added as a serious adverse event. More information
- On September
13, FDA approved changes to the product
labeling for oprelvekin (Neumega) to
include new warnings on ophthalmologic and
ventricular arrhythmias adverse events. More
information
- On July 24,
FDA approved pegaspargase (Oncaspar,
Enzon Pharmaceuticals, Inc) for the
first-line treatment of patients with acute
lymphoblastic leukemia. More
information
- On July 14,
FDA approved gemcitabine (Gemzar) in combination with
carboplatin for the treatment of patients with
advanced ovarian cancer that has relapsed at
least 6 months after completion of platinum
based therapy. More
information
- On June
29, FDA approved lenalidomide oral
capsules (Revlimid), Celgene Corporation)
for use in combination with dexamethasone in
patients with multiple myeloma who have
received one prior therapy. More
information
- On June 28,
FDA approved dasatinib (Sprycel) for
use in the treatment of adults with
chronic phase, accelerated phase, or myeloid
or lymphoid blast phase chronic myeloid
leukemia. More information
- On June 20,
FDA approved the labeling extension for bevacizumab (Avastin) for second-line
treatment of metastatic carcinoma of the
colon or rectum. More information
- On June 14,
FDA approved topotecan hydrochloride (Hycamtin) in combination with cisplatin for the
treatment of Stage IVB recurrent or
persistent carcinoma of the cervix. More information
- Dr.
Robert Justice Selected as the Director
of the Division of Drug Oncology Products. More
Information
- On June 8,
FDA licensed Quadrivalent Human
Papillomavirus (Types 6, 11, 16, 18)
Recombinant Vaccine (Gardasil) for the
prevention of cervical cancer and other
diseases in females caused by Human
Papillomavirus. More
information
- On May 26, FDA
granted accelerated approval for thalidomide
(Thalomid) in
combination with dexamethasone for the
treatment of newly diagnosed multiple
myeloma (MM) patients.
More Information
- On May 2, FDA approved decitabine for
injection (Dacogen) for
the treatment of patients with myelodysplastic syndromes (MDS).
More Information
- On March 3, the Division of Biologic Oncology
Products in FDA's Office of Oncology Drug
Products (OODP) approved changes to the
product labeling for denileukin diftitox
(Ontak) to include a new warning on
ophthalmologic adverse events.
More information
- On March 1, FDA
granted approval to cetuximab (Erbitux) for use in
combination with radiation therapy (RT) for
the treatment of locally or regionally
advanced squamous cell carcinoma of the head
and neck (SCCHN) or as a single agent for
the treatment of patients with recurrent or
metastatic SCCHN for whom prior
platinum-based therapy has failed.
More information
- On February
10, FDA granted approval to rituximab
(Rituxan) for use
in the first‑line treatment of patients with
diffuse large B-cell, CD20‑positive,
non-Hodgkin's lymphoma in combination with
CHOP or other anthracycline‑based
chemotherapy regimens.
More information
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Office of Oncology
Drug Products
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