Puma May Face Marketing Hurdles Even If Neratinib Wins Final Approval
Neratinib's value as extended adjuvant therapy for HER2-positive breast cancer may be diminished if Roche succeeds in altering the standard of care for initial adjuvant treatment, among other challenges.
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A positive opinion on the marketing application for Puma's neratinib in the EU is unlikely next month after a recent discussion with regulators failed to satisfy risk-benefit concerns, but more data on controlling diarrhea are expected shortly.
Five funds raised more than $1bn to back biotech firms; Arcus leads recent VC rounds with $107m GV-backed Series C; Celgene, Valeant sell notes to retire debt; and Alnylam cashes in on investor goodwill.
US FDA labeling details the differences in performance of neratinib in adjuvant breast cancer by subgroup, as well as results relative to the timing of Roche's Herceptin, but the drug's indication covers all.