The latest approval for Kadcyla is for HER2-positive early breast cancer patients with residual invasive disease after being subjected to neoadjuvant treatment with taxane and Herceptin (trastuzumab).
The drug was previously approved as monotherapy in 104 countries, including the US and EU for treatment of HER2-positive metastatic breast cancer in patients who were previously subjected to Herceptin and taxane chemotherapy, either separately or in combination.
Its latest approval as adjuvant treatment of HER2-positive early breast cancer was based on the results of the phase 3 KATHERINE study. In the late-stage study, Kadcyla significantly brought down the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin.
The drug was evaluated in the trial as an adjuvant treatment of HER2-positive early breast cancer in patients with residual invasive disease after receiving neoadjuvant taxane and Herceptin-based treatment.
Roche submitted a supplemental biologics license application (sBLA) with the FDA for Kadcyla in February 2019. The drug was granted breakthrough therapy designation for the desired indication.
The regulator reviewed and approved the sBLA under its real-time oncology review (RTOR) and assessment aid pilot programs, in a little over 12 weeks of the date of submission.
Roche chief medical officer and global product development head Sandra Horning said: “This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot programme, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated.
“With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure.”
According to Roche, Kadcyla was designed to deliver potent chemotherapy to HER2-positive cancer cells directly, thereby potentially minimizing damage to healthy tissues. The ADC combines two anti-cancer agents the HER2-targeting trastuzumab and the chemotherapy agent DM1 by using a stable linker.