Pfizer Halts Phase III Figitumumab Trial In NSCLC But Forges On With Other Studies
This article was originally published in The Pink Sheet Daily
Executive Summary
Insulin growth factor-1 receptor inhibitor is one of Pfizer's lead oncology candidates, but the company is not throwing in the towel on figitumumab yet.
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In Brief
Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11
In Brief
Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11