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What's on Radar These Days?

It’s notable that in President Obama’s recent, first speech before Congress, the only disease mentioned in addressing the country’s urgent need for health care reform was cancer. Obama pledged “to seek a cure for cancer in our time,” a tall order that has so far eluded researchers.

Each cancer drug approval and every trial represents yet another step towards achieving that elusive goal. Yet we were reminded again of the risks associated with cancer drug development last week with the negative outcome of the Phase 3 study evaluating elesclomol [Synta, GSK] in melanoma. With that in mind, we wanted to pique your interest in looking at OBR’s RADAR, just updated, to see what’s on the horizon in 1H09 for oncology drugs in the way of pending FDA decisions and anticipated key clinical trial data:

Pivotal Phase 3 results due:

  • Mid-April 2009: Avastin® [Genentech/Roche] adjuvant colon cancer data from the NSABP C-08 trial
  • April 2009: Provenge® [Dendreon] advanced prostate cancer data from the IMPACT trial
  • June 2009: picoplatin [Poniard] small cell lung cancer data from the SPEAR trial

Upcoming PDUFA action dates:

  • March 9, 2009: Afinitor® [Novartis] for advanced kidney cancer
  • May 24, 2009: Clolar® [Genzyme] for adult acute myeloid leukemia (AML)
  • July 2, 2009: Zevalin® [Spectrum Pharmaceuticals] as first-line consolidation therapy in B-cell follicular non-Hodgkin's lymphoma (NHL)

OBR Radar was developed to keep our reading audience ahead of market moving events in oncology. For more information and the latest updates, go to http://www.obroncology.com/radar.php or just click on the RADAR icon in any edition of OBR daily.

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