ST LOUIS (MD Consult) - On January 29, 2010, the US Food and Drug Administration (FDA) and GlaxoSmithKline (GSK) announced the accelerated approval of antineoplastic agent Tykerb (lapatinib) for use in combination with Femara (letrozole) as a first-line treatment for hormone-positive and human epidermal growth factor receptor 2 (Her-2)–positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. This combination is an entirely oral treatment regimen.

Tykerb, a kinase inhibitor, was initially approved in combination with Xeloda (capecitabine) in 2007 for the treatment of Her-2–positive advanced breast cancer tumors in patients who had previously undergone chemotherapy that included an anthracycline, a taxane, and trastuzumab.

The approval of Tykerb for this indication was supported by results from a company-sponsored, double-blind, placebo-controlled study of 219 women with postmenopausal, hormone-receptor–positive, and Her-2–positive metastatic breast cancer. Women in the study who were treated with lapatinib and letrozole in combination experienced a 5.2-month increase in median progression-free survival compared with women treated with letrozole alone. The impact of this combination therapy on overall survival is not yet known.

According to GSK, safety information from this study was consistent with previous Tykerb clinical studies in advanced breast cancer. The most commonly reported adverse effects of combination therapy were diarrhea, rash, nausea, and fatigue.

Treatment with Tykerb has been associated with decreases in cardiac function, liver damage, and interstitial lung disease/pneumonitis. Fetal harm may occur if the product is used to treat advanced breast cancer in pregnant women.

 

圣路易斯(MD Consult)——2010年1月29日，美国食品药品管理局(FDA)与葛兰素史克(GSK)宣布，将加快批准抗肿瘤药Tykerb(拉帕替尼)与弗隆(来曲唑)联合用于激素阳性及人表皮生长因子受体2(Her-2)阳性晚期乳腺癌的一线治疗。适用人群为适用激素治疗的绝经后女性患者。 这种联合治疗是完全口服的治疗方案。

 

激酶抑制剂Tykerb最初于2007年获批与希罗达(卡培他滨)联合用于治疗曾接受过化疗(包括蒽环类药物、紫杉烷和曲妥珠单抗)的Her-2阳性晚期乳腺癌患者。

Tykerb获批用于治疗该适应证是基于一项公司资助的双盲、安慰剂对照研究的结果。该研究共纳入219例罹患激素受体阳性及Her-2阳性转移性乳腺癌的绝经后女性患者。在该研究中，与拉帕替尼单药治疗组相比，拉帕替尼/来曲唑联合治疗组的中位无进展生存期增加了5.2个月。这种联合治疗对总生存期的影响尚不清楚。

 

GSK表示，来自该研究的安全性信息与此前探讨Tykerb治疗晚期乳腺癌的临床研究一致。这种联合治疗所致的最常见不良反应为腹泻、皮疹、恶心和乏力。

Tykerb治疗与心功能下降、肝损害和间质性肺病/肺炎相关。如应用该药治疗妊娠期合并晚期乳腺癌的患者，则可能会伤害胎儿。