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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