AstraZeneca withdraws Zactima from EMEA and FDA in lung cancer - Pharma Strategy Blog

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October 28, 2009

AstraZeneca withdraws Zactima from EMEA and FDA in lung cancer

Earlier this year I posted about the interim results in non-small cell lung cancer (NSCLC) for AstraZeneca's Zactima (vandetanib) at the ASCO meeting, as part of a review about VEGF inhibitors.  Of the 3 trials available for review, one showed some responses and the other two 'had not yet reached significance'.

Unfortunately, it now seems that the final survival data was indifferent at best and AstraZeneca announced the sudden withdrawal of the marketing applications to the regulatory authorities this morning:

"The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint may not be sufficient for approval."

Granted that oncology is a difficult area to develop new drugs, but the woes in this category have made for a sad and sorry 2009 for R&D this year so far.

With 2 months to go, perhaps we might see a stunning winner yet...

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• Oncology R&D can be a wild ride (pharmastrategyblog.com)
• Gene Mutation Improves Response to Lung Cancer Drug (nlm.nih.gov)
• What's hot at the ESMO conference this week? (pharmastrategyblog.com)
• AstraZeneca Pulls Cancer Drug Applications (online.wsj.com)

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Posted by MaverickNY on October 28, 2009 in Drugs, Lung Cancer, Market Intelligence, Marketing, News, Oncology, Pipeline, Targeted Therapies | Permalink

Technorati Tags: AstraZeneca, NSCLC, vandetanib, VEGF, Zactima

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AstraZeneca withdraws Zactima from EMEA and FDA in lung cancer

Earlier this year I posted about the interim results in non-small cell lung cancer (NSCLC) for AstraZeneca's Zactima (vandetanib) at the ASCO meeting, as part of a review about VEGF inhibitors.  Of the 3 trials available for review, one showed some responses and the other two 'had not yet reached significance'.

Unfortunately, it now seems that the final survival data was indifferent at best and AstraZeneca announced the sudden withdrawal of the marketing applications to the regulatory authorities this morning:

"The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint may not be sufficient for approval."

Granted that oncology is a difficult area to develop new drugs, but the woes in this category have made for a sad and sorry 2009 for R&D this year so far.

With 2 months to go, perhaps we might see a stunning winner yet...

Related articles by Zemanta

• Oncology R&D can be a wild ride (pharmastrategyblog.com)
• Gene Mutation Improves Response to Lung Cancer Drug (nlm.nih.gov)
• What's hot at the ESMO conference this week? (pharmastrategyblog.com)
• AstraZeneca Pulls Cancer Drug Applications (online.wsj.com)

via pharmastrategyblog.com

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