FDA Approves Tarceva For Pancreatic Cancer
This article was originally published in The Pink Sheet Daily
Executive Summary
Supplemental NDA approval for Genentech/OSI’s erlotinib, previously approved for lung cancer, follows advisory committee recommendation.
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Roche Appeals Negative EMEA Decision For Tarceva Pancreatic Cancer Indication
EMEA has 60 days to review Tarceva on appeal; the oncologic is approved for treatment of advanced pancreatic cancer in the U.S.
Roche Appeals Negative EMEA Decision For Tarceva Pancreatic Cancer Indication
EMEA has 60 days to review Tarceva on appeal; the oncologic is approved for treatment of advanced pancreatic cancer in the U.S.
Tarceva Pancreatic Cancer Indication Turned Down In The EU
Roche will consider requesting a re-examination of the negative decision by the Committee for Medicinal Products for Human Use.