FDA Panel Review Alert : Cell Therapeutics, ChemGenex Pharma

(RTTNews) - The Food and Drug Administration's Oncologic Drugs Advisory Committee is scheduled to review Cell Therapeutics Inc.'s (CTIC: News ) New Drug Application for Pixuvri (Pixantrone) for the treatment of relapsed and refractory non-Hodgkin lymphoma tomorrow. (March 22).

The FDA panel was originally scheduled to review Cell Therapeutics' application for Pixuvri on February 10, but was postponed because of severe weather conditions then. The company is seeking approval for Pixuvri injection as a single agent treatment for patients with recurring or refractory , aggressive non-Hodgkin lymphoma who have received two or more prior lines of therapy.

Pixuvri came into Cell Therapeutics' fold following the 2003 acquisition of Novuspharma, a publicly traded Italian company. Novuspharma was acquired in a share-swap deal valued at about $236 million. The transaction was completed on January 1, 2004.

According to Cell Therapeutics, in a phase III trial dubbed EXTEND, patients who were treated with Pixuvri attained a high rate of persistent and unconfirmed complete remissions (absence of disease activity) compared to patients treated with standard chemotherapy.

Additionally, patients treated with Pixuvri experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents. The overall response rate was also significantly higher in the Pixuvri arm compared to the control arm, according to the company.

In February, the FDA staffers had raised questions about the efficacy and safety of Pixuvri.

Early this month, the FDA completed its inspection of the facility at NerPharMa, which manufactures Pixuvri, and found the site in compliance and acceptable for continued manufacturing of the drug product.

Yet another company facing the FDA panel tomorrow (March 22) is Australian drugmaker ChemGenex Pharmaceuticals Ltd. (CXSPY.PK: News ). The company is seeking regulatory approval for Omapro injection for the treatment of adults with chronic myeloid leukemia bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with Novartis AG's (NVS) Gleevec.

The FDA panel was originally scheduled to review the application for Omapro on February 10, but was postponed because of severe weather conditions then. In briefing documents posted online in February, the FDA staff said that Omapro showed a low response rate in clinical trial.

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by RTT Staff Writer

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