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Cell TherapeuticsInc. (CTIC) recently announced that the resubmitted new drug application (“NDA”) for its lead pipeline candidate pixantrone will be reviewed by a panel of the US Food & Drug Administration (“FDA”) on February, 9, 2012.
Pixantrone has been developed for the treatment of relapsed or refractory aggressive non-Hodgkin’s lymphoma (“NHL”) in patients who have not responded to other treatment options. The Oncologic Drugs Advisory Committee (“ODAC”) will review the additional data and information which was submitted by Cell Therapeutics on the recommendation of the Office of New Drugs (“OND”) of the FDA in May 2011. The final FDA decision on pixantrone is expected in April 24, 2012.
In April 2010, the FDA had issued a complete response letter (“CRL”) to the original NDA for pixantrone, based on concerns that the trial PIX301 did not sufficiently prove the effectiveness of the drug. PIX301 was the basis of the original NDA filed by Cell Therapeutics for approval of pixantrone. The FDA asked Cell Therapeutics to conduct an additional trial to determine the safety and efficacy of pixantrone. Even though the company began an additional trial (PIX306) for pixantrone, it appealed to the OND of the FDA in December 2010 to reverse the FDA’s earlier decision to deny approval to pixantrone.
In early May 2011, Cell Therapeutics met with the OND which allowed the company to re-submit the NDA for review without the need for an additional trial. The OND recommended that Cell Therapeutics will have to conduct an additional independent radiologic review, utilizing a new independent panel of radiologists, of the PIX301 trial to determine the soundness of the primary endpoint. In late September 2011, the additional independent radiologic review of data from PIX301, by an independent panel of three radiologists, confirmed the statistical significance of response and progression endpoints of the study. The OND also required the company to submit new information regarding the circumstances that prompted an early halt of the PIX301 trial.
Cell Therapeutics resubmitted the NDA on the basis of results of the radiologic review in late October 2011. Cell Therapeutics is looking for accelerated approval of the NDA. Cell Therapeutics believes the resubmitted NDA addresses all the concerns raised in the CRL as well as includes all information required by the OND. Pixantrone is also under review in the European Union (“EU”) and an opinion from the Committee for Human Medicinal Products ("CHMP") of the European Medicines Agency ("EMA") is expected on January 19, 2012.
Currently, we have an Outperform recommendation on Cell Therapeutics. The company carries a Zacks #3 Rank (“Hold” rating) in the short run. With the re-submitted NDA for pixantrone accepted for review, we believe the company has moved closer to getting the candidate approved. Moreover, Cell Therapeutics’ other pipeline drugs, Opaxio and tosedostat also focus on different types of cancers.