Roche is aiming to hasten use of its breast cancer drug Kadcyla with the submission to the FDA under the Real-Time Oncology Review and Assessment Aid programme.
Kadcyla (trastuzumab emtansine) is for the adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.
The Real-Time Oncology review was piloted by the FDA last year allowing the regulator to access clinical data immediately after ‘data lock’ on a trial and before a pharma company carries out its analysis. All in all it aims to assist the pharma company as to what data would help the drug receive clinical approval.
Sandra Horning, chief medical officer and head of global product development at Roche, said: “Kadcyla was granted Breakthrough Therapy Designation and is also the first Roche medicine tho be reviewed under the FDA’s Real-Time Oncology Review pilot programme.”
Today’s application comes on the back of data from the phase III KATHERINE study which showed that as a second-line treatment, Kadcyla significantly reduced invasive disease-free survival compared to blockbuster Herceptin (trastuzumab).
The study showed that after three years of treatment, around 88% of those treated with Kadcyla did not see their breast cancer return compared with just 77% for those treated with Herceptin.
A green light for Kadcyla from the FDA will ultimately assist Roche fight off competition from Herceptin biosimilars which are creeping into the market as patent expiry will happen this coming June.