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Breast cancer Tx Ibrance¡¯s AE rate at 86%...6yr PMS results

By Lee, Hye-Kyung | translator Kim, Jung-Ju

23.06.22 05:50:34

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Post-marketing surveillance conducted on 293 patients in Korea...8 report serious adverse drug reactions

MFDS prepared a labeling change plan...will collect opinions until the 5th of next month


Post-marketing surveillance results of Pfizer Korea¡¯s breast cancer treatment ¡®Ibrance Cap (palbociclib)¡¯ showed an adverse event rate of 86.01% for the drug.

The Ministry of Food and Drug Safety prepared a label change order (draft) items based on its reevaluation results and will be conducting an opinion inquiry until the 5th of next month.

The results of the post-marketing surveillance study conducted by Pfizer on 293 people for 6 years for its reevaluation showed that Ibrance¡¯s reported adverse event rate was 86.01% (252/293 people, 642 cases), regardless of a causal relationship.

Of these, 2.73% (8/293 patients, 11 cases) were serious adverse reactions (ADRs) whos

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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