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FDA grants orphan drug designation to Reolysin for malignant gliomas

April 17, 2015

The FDA today granted orphan drug designation to pelareorep for the treatment of patients with malignant gliomas, according to a press release from the drug’s manufacturer.

The FDA based its decision in part on results of three brain cancer studies of pelareorep (Reolysin, Oncolytics Biotech) in gliomas. Study results demonstrated that pelareorep infected a variety of brain tumors when administered intravenously.

Sunit Das, MD, PhD In the Journals

Hypofractionated radiation, temozolomide effective in elderly patients with glioblastoma

April 17, 2015
Hypofractionated radiotherapy or temozolomide monotherapy may be a viable treatment option for elderly patients with glioblastoma multiforme, according to results of a…
FDA News

FDA grants orphan drug status to pritumumab for brain cancer

April 10, 2015
The FDA has granted orphan drug designation to pritumumab for the treatment of brain cancer, according to a press release from the drug’s manufacturer.According to…
Industry News

VB-111 plus bevacizumab confers positive interim results in recurrent glioblastoma

March 26, 2015
Interim results from an ongoing phase 2 study demonstrated that patients with recurrent glioblastoma who received VB-111 alone and subsequently with bevacizumab achieved…
CME CNE
Stem Cell Transplant for AAMDS

Treatment Decision-Making through the Spectrum of MDS:
Case 3 Stem Cell Transplant for MDS

An educational presentation from Aplastic Anemia & MDS International Foundation.

MDS is a difficult disease to diagnose and treat. Frequently it is challenging for healthcare providers to explain to…
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CME
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Targeted Therapy and Immunotherapy in the Management of Metastatic Melanoma: 2014 Updates

This activity is supported by an educational grant from Merck & Co., Inc.

Melanoma remains a challenging condition for clinicians. An array of targeted therapies and immunotherapy are in…
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FDA News

FDA grants orphan drug designation to Reolysin for malignant gliomas

April 17, 2015
The FDA today granted orphan drug designation to pelareorep for the treatment of patients with malignant gliomas, according to a press release from…
Sunit Das, MD, PhD In the Journals

Hypofractionated radiation, temozolomide effective in elderly patients with glioblastoma

April 17, 2015
Hypofractionated radiotherapy or temozolomide monotherapy may be a viable treatment option for elderly patients with glioblastoma multiforme…
FDA News

FDA grants orphan drug status to pritumumab for brain cancer

April 10, 2015
The FDA has granted orphan drug designation to pritumumab for the treatment of brain cancer, according to a press release from the drug’s…
Industry News

VB-111 plus bevacizumab confers positive interim results in recurrent glioblastoma

March 26, 2015
Interim results from an ongoing phase 2 study demonstrated that patients with recurrent glioblastoma who received VB-111 alone and subsequently with…
In the Journals

Metronomic temozolomide extends PFS, OS in EGFR-amplified glioblastoma

March 16, 2015
Patients with epidermal growth factor receptor-amplified and -overexpressing glioblastomas demonstrated a significant benefit from metronomic…
Richard Pazdur, MD FDA News

FDA approves Unituxin for pediatric patients with high-risk neuroblastoma

March 10, 2015
The FDA today announced the approval of dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma, according to a press…
Breaking News

Oraya receives CE mark extension for IRay to treat choroidal metastases

March 3, 2015
The Oraya IRay radiotherapy system received a CE mark extension for the treatment of choroidal metastases, expanding on prior approval for treatment…
In the Journals

Chest CT imaging may safely be omitted from neuroblastoma surveillance for pediatric patients

February 27, 2015
Neuroblastoma progression or recurrence in the chest is rare among children and usually can be detected with non-CT imaging modalities or through the…
FDA NewsDrug Pipeline

FDA grants breakthrough therapy designation to Rintega for EGFRvIII-positive glioblastoma

February 23, 2015
 The FDA today granted breakthrough therapy designation to rindopepimut for the treatment of adults with epidermal growth factor receptor…
FDA NewsDrug Pipeline

FDA grants orphan drug status to BXQ-350 for treatment of glioblastoma multiforme

February 16, 2015
The FDA granted orphan drug designation to BXQ-350, an agent in development for treatment of glioblastoma multiforme.BXQ-350 (Bexion Pharmaceuticals)…
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