パルボシクリブとトラスツズマブの併用療法が、HR陽性、HER2陽性の転移性乳がんに対して米国FDAにより承認されました – Oncology Central

記事本文

US FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer. The Food and Drug Administration has approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment. Full prescribing information for palbociclib will be posted on Drugs@FDA. Efficacy was evaluated in PATINA (NCT02947685), a randomised, open-label trial in 518 patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer who had no evidence of disease progression after induction treatment with a taxane and trastuzumab, with or without pertuzumab, for their advanced disease. Patients were randomized (1: 1) to receive either palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy (fulvestrant or an aromatase inhibitor [anastrozole, letrozole, or exemestane]) or trastuzumab, with or without pertuzumab, and endocrine therapy alone. Patients received treatment until disease progression or unacceptable toxicity. The major efficacy outcome measure was investigator-assessed progression-free survival (PFS) per RECIST version 1.1. Overall survival (OS) was an additional efficacy outcome measure. A statistically significant improvement in investigator-assessed PFS was observed for palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy compared to trastuzumab, with or without pertuzumab, and endocrine therapy alone (Hazard ratio 0.76,1-sided p-value 0.0134). Median PFS could not be adequately described because of censoring. At the time of the PFS analysis, OS data were not mature. The palbociclib prescribing information includes warnings and precautions for neutropenia, interstitial lung disease/pneumonitis, and embryo-fetal toxicity. The recommended palbociclib dosage is 125 mg orally once daily for 21 consecutive days, followed by seven days off treatment to comprise a complete cycle of 28 days. Refer to the prescribing information for the recommended dosages for trastuzumab, pertuzumab, and endocrine therapy. This article has been republished from the following materials. Material may have been edited for length and house style. For further information, please contact the cited source. Our press release publishing policy can be accessed here.