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12:00 AM
Mar 29, 2010
 |  BioCentury  |  Regulation

No dice for Pixuvri

FDA cancer panel cites trial flaws to reject Pixuvri from Cell Therapeutics

Although Cell Therapeutics Inc. failed to completely enroll its single Phase III study of Pixuvri pixantrone, it bet the results provided sufficient evidence to support accelerated FDA approval of the compound for use to treat aggressive non-Hodgkin's lymphoma in patients with relapsed/refractory disease.

The gamble did not pay off at last week's review by FDA's Oncologic Drugs Advisory Committee, which unanimously concluded the company had failed to provide adequate evidence to support approval, even if the results did suggest that Pixuvri is an active agent.

Front-line therapy for aggressive NHL is CHOP-R, a combination of chemotherapeutics (doxorubicin, cyclophosphamide, vincristine and prednisone) plus Rituxan rituximab. The 30-40% of patients who relapse typically turn to high-dose myeloablation followed by autologous stem cell transplant.

Anthracyclines such as doxorubicin form the cornerstone of therapy for many cancers, including leukemias and lymphomas.

Pixuvri is an aza-anthracenedione chemotherapeutic. Like the anthracyclines, Pixuvri is a topoisomerase II (TOP2) inhibitor, but Cell Therapeutics believes its structural differences should increase the stability of DNA adduct formation and reduce oxygen free radical formation.

As a result, the company hypothesized Pixuvri's mechanism would make it more effective than anthracyclines while avoiding the cardiotoxicity issues that limit their use.

According to John Leonard, professor of hematology and medical oncology at Weill Cornell Medical College and...

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