publication date: Jul. 10, 2015

Lilly Drug to Change Squamous NSCLC, but ODAC’s Opinion is Nuanced



The FDA Oncologic Drugs Advisory Committee July 9 appears to have recommended approval for the Eli Lilly and Co. agent necitumumab.

Yes, the word “appears” has indeed appeared in the previous sentence.

It had to because, in breaking with a long-standing tradition, the agency asked ODAC members to “discuss” the key questions of risk vs. benefit of the experimental therapy instead of reducing their answers to a yea or nay vote.

No vote was taken, but The Cancer Letter’s analysis of ODAC’s discussion suggests that, had a vote been taken, necitumumab would have received an overwhelming 11:1 vote in favor of approval.

Thus, it’s a fair guess that the agent is heading toward becoming a part of front-line treatment of locally advanced or metastatic squamous non-small cell lung cancer.

Approval of this Biologics License Application is important, because the treatment of squamous NSCLC hasn’t changed in over 15 years. Necitumumab would be used in combination with a doublet treatment of gemcitabine and cisplatin.

Apparent (that word again; sorry) procedural change at FDA is a landmark as well. If the agency indeed intends to solicit discussion rather than votes from its clinical advisors, it will acquire far more flexibility in making approval decisions.

In the era when cancer care becomes increasingly specialized, this is certain to have … Continue reading 41-27 Lilly Drug to Change Squamous NSCLC, but ODAC’s Opinion is Nuanced

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