Roche has submitted a supplemental biologics license application seeking approval from the US Food and Drug Administration (FDA) for the expanded use of its Kadcyla (trastuzumab emtansine) drug in breast cancer.
The new indication covers adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC) patients having residual disease even after neoadjuvant (before surgery) therapy.
Kadcyla is an antibody-drug conjugate (ADC) designed to deliver potent chemotherapy directly to HER2-positive cancer cells.
It features a combination of HER2-targeting properties of trastuzumab and chemotherapy agent DM1. Roche licenses technology for the drug from ImmunoGen.
The drug already holds approval as a monotherapy to treat HER2-positive metastatic breast cancer patients who had prior Herceptin, another Roche breast cancer drug, and taxane chemotherapy.
In the application for expanded indication, Roche included findings from the Phase III KATHERINE clinical trial designed to assess the efficacy and safety of Kadcyla.
Results demonstrated significant decrease in the risk of invasive breast cancer recurrence or death from any cause when treated with Kadcyla as an adjuvant therapy, compared to Herceptin.
Around 88.3% of patients who received Kadcyla did not experience breast cancer recurrence compared to 77% treated with Herceptin.
Roche chief medical officer and Global Product Development head Sandra Horning: “Kadcyla was granted breakthrough therapy designation and is also the first Roche medicine to be reviewed under the FDA’s Real-Time Oncology Review pilot programme; both FDA initiatives aim to expedite reviews and bring medicines to patients sooner.
“We are working closely with the FDA to bring Kadcyla to people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy as early as possible.”
Herceptin has been one of Roche’s lead products, fetching $7bn in sales last year, reported Reuters.
However, the drug’s European patent expired paving way for cheaper biosimilar products.
Herceptin is also set to face competition in the US this year with the launch of multiple biosimilars, including those from Pfizer, Mylan, Teva and Celltrion.