Roche Korea said that it has received additional indication approval for Kadcyla, its HER2+ breast cancer drug, from the Ministry of Food and Drug Safety.
|Roche's HER2+ breast cancer drug Kadcyla|
Under the new regulation, hospitals can now use Kadcyla as postoperative adjuvant therapy in patients with HER2-positive early breast cancer with invasive residual lesions after receiving taxane and trastuzumab-based preoperative adjuvant therapy.
The ministry approved the expanded indication after Roche confirmed the treatment's efficacy through a global phase 3 KATHERINE clinical trial in patients with HER2-positive early breast cancer with invasive residual cancer identified at the surgical site or in the axillary lymph node following preoperative adjuvant therapy based on trastuzumab and taxanes.
The company either administered Kadcyla-alone or trastuzumab-alone for 14 cycles as an adjuvant therapy to patients participating in the trial. The primary endpoint of the trial was invasive disease-free survival (iDFS).
Results from the KATHERINE study showed that Kadcyla alone improved iDFS significantly compared to trastuzumab alone, reducing the risk of relapse by 50 percent.
The effects of Kadcyla's risk of recurrence in the KATHERINE clinical trials were consistent in subgroup analyses, depending on whether the hormone receptors and lymph nodes were positive or on the type of target anticancer drugs administered during preoperative adjuvant therapy. There were also no new safety signals identified.
"As confirmed by clinical trials, Kadcyla has dramatically reduced the risk of recurrence, which is most important in the treatment of breast cancer," Roche Korea CEO Nic Horridge said. "Roche has developed and delivered a range of treatment options tailored to patient characteristics, from HER2-positive early breast cancer to metastatic breast cancer, with treatment such as Herceptin, Perjeta, and Kadcyla."