Puma touts its latest advances in a basket trial for Nerlynx, as Europeans appear ready to reject the drug
While European regulators appear ready to slap down Puma Biotechnology’s $PBYI first shot at an approval for Nerlynx (neratinib), the company is pushing ahead with a basket trial it hopes to use to eventually use to broaden its initial FDA approval for breast cancer to a whole range of solid tumors.
In the first cut of the SUMMIT study, researchers say they noted that “responses were observed in patients with breast, cervical, biliary, salivary and non-small-cell lung cancers, which led to cohort expansions in these tumor types. No activity was observed in the HER3-mutant cohort.”
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