Adding the novel CDK4/6 inhibitor tibremciclib (Betta Pharmaceuticals) to second-line fulvestrant significantly extended progression-free survival (PFS) in patients with HR-positive/ HER2- negative advanced breast cancer , but with the tradeoff of increased toxicity, new data suggest.

Compared with fulvestrant alone, the combination prolonged median PFS for these patients by 11 months, according to results from the phase 3 TIFFANY trial. However, similar to existing CDK4/6 inhibitors, the tibremciclib-fulvestrant combination added to treatment side effects — including substantially higher rates of diarrhea , hematologic toxicities, and hypokalemia .

The authors of the analysis, published in JAMA Oncology , described the toxicities as "manageable," emphasizing that few patie

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