Puma's once-vaunted cancer drug dogged by side effects in Phase II results

Puma Biotechnology's ($PBYI) in-development breast cancer treatment demonstrated some clinical benefit in a Phase II trial, but the high rates of serious diarrhea that have long plagued the drug again resurfaced, clouding the therapy's regulatory future. Puma's neratinib charted a 32% response rate in interim results from a 20-patient cohort presented at the San Antonio Breast Cancer Symposium, an effect the company called encouraging. But 35% of women in the group came down with grade 3 diarrhea despite getting 16 mg of Imodium per day. Puma, whose shares fell about 11% on the news, is planning to file the drug for FDA approval in the first quarter of next year. Release

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