Novantrone Gets FDA Nod for Use in Advanced Prostate Cancer
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`Published on Cancer Network (http://www.cancernetwork.com)
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`Home > Novantrone Gets FDA Nod for Use in Advanced Prostate Cancer
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`Novantrone Gets FDA Nod for Use in Advanced
`Prostate Cancer
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`December 01, 1996 | Genitourinary Cancers [1], Prostate Cancer [2]
`ROCKVILLE, Md--The FDA has approved a new indication for Novan-trone
`(mitoxantrone), making it the first chemotherapy agent approved for the treatment of
`advanced hormone-refractory prostate cancer. Novantrone in combination with
`corticosteroids has been shown to reduce bone pain and stabilize or reduce reliance on
`analgesics in these patients without adversely affecting quality of life.
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`ROCKVILLE, Md--The FDA has approved a new indication for Novan-trone
`(mitoxantrone), making it the first chemotherapy agent approved for the treatment of
`advanced hormone-refractory prostate cancer. Novantrone in combination with
`corticosteroids has been shown to reduce bone pain and stabilize or reduce reliance on
`analgesics in these patients without adversely affecting quality of life.
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`"As a urologist who works with medical oncologists to treat prostate cancer patients, I am
`excited about this new indication," Judd Moul, MD, of the Walter Reed Medical Center,
`said in an interview with Oncology News International. "It is a new concept to have a
`chemotherapy that works well for bone pain and can be of palliative benefit to patients
`with end-stage prostate cancer."
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`He said that results with Novantrone are often seen very quickly, with some patients
`getting pain relief within a day or so after administration. "It doesn't happen every time, but
`when it happens, it's certainly beneficial for both the patient and the physician," he said.
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`Novantrone, marketed by the Immunex Corporation, Seattle, Washington, was first
`approved in the United States in 1987 for the treatment of acute myelogenous leukemia
`(AML).
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`The supplemental application, submitted just 6 months ago, was given priority review
`status by the FDA under the user-fee guidelines, and was one of the first submitted after
`the FDA announced its initiative to speed cancer drug approvals in 1996.
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`Novantrone is also in phase II clinical trials in North America for the treatment of
`metastatic breast cancer and in phase I/II trials for non-Hodgkin's lymphoma.
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`Pivotal Study
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`http://www.cancernetwork.com/print/172210
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`12/22/2016
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`AVENTIS EXHIBIT 2154
`Mylan v. Aventis IPR2016-00712
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`Novantrone Gets FDA Nod for Use in Advanced Prostate Cancer
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`Page 2 of 2
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`In a pivotal study conducted by Ian Tannock, MD, and his colleagues at the University of
`Toronto, 161 patients with advanced hormone-refractory prostate cance were randomized
`to receive prednisone alone or predinosone with Novantrone.
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`The study, published in the Journal of Clinical Oncology, found that 38% of patients
`receiving Novantrone had a marked reduction in severe bone pain, which in some patients
`reduced their requirement for pain medications by half. Only 21% of patients who had
`received prednisone alone achieved the same degree of pain relief.
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`Median duration of pain relief was four times longer for patients who responded to
`Novantrone (8 months versus 2 months for those who received prednisone alone). There
`was no difference in survival between the two treatment groups.
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`Novantrone was well tolerated in these patients. Adverse effects include neutro-penia and
`the usual side effects associated with chemotherapy (nausea and vomiting, fatigue, and
`alopecia).
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`Said E. David Crawford, MD, of the University of Colorado, "Novantrone's approval is an
`important advance because physicians have had very few options to effectively manage
`hormone-resistant prostate cancer. Now we can offer a treatment that can reduce the pain
`of prostate cancer by working on the cancer itself."
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`In a press release, Us Too!, the Illinois-based prostate cancer patient advocacy
`organization, called the agent "an important addition to the currently limited treatment
`options available to patients with advanced disease." Said
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`Henry A. Porterfield, CEO of Us Too!, "Maintaining a good quality of life is a key goal in
`treating late-stage prostate cancer patients. We are hopeful that new therapy
`developments like Novantrone will contribute to achieving this goal."
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`Source URL: http://www.cancernetwork.com/articles/novantrone-gets-fda-nod-use-advanced-prostate-
`cancer
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`Links:
`[1] http://www.cancernetwork.com/genitourinary-cancers
`[2] http://www.cancernetwork.com/prostate-cancer
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`http://www.cancernetwork.com/print/172210
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`12/22/2016