Roche seeks Kadcyla boost to fend off Herceptin biosimilars


As biosimilar competition to Herceptin ramps up, Roche is looking to bolster its position in HER2-positive breast cancer with a new indication for Kadcyla.

The Swiss pharma firm has announced that it has submitted a supplemental Biologics License Application to the US FDA that could broaden the drug’s use to post-surgical treatment of people with HER2-positive early breast cancer, who still had signs of disease after they were treated before surgery.

Kadcyla (trastuzumab emtansine) is already approved for people with metastatic HER2-positive breast cancer after treatment with Herceptin (trastuzumab) and chemotherapy.

Though Roche once dominated the HER2 space, recent months have seen a slew of approvals for biosimilars of Herceptin, its best-selling drug, as its patent expiry approaches – including candidates from Samsung Bioepis and Merck & Co, Celltrion and Teva, and Mylan and Biocon.

The new indication for Kadcyla could once again give Roche an advantage over competitors in the space.

The application is based on results of the phase III KATHERINE study showing Kadcyla reduced the risk of invasive breast cancer recurrence or death from any cause by 50%, compared to Herceptin (trastuzumab) as an adjuvant treatment in this indication.

The FDA will review the application under the Real-Time Oncology Review and Assessment Aid pilot programmes, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

For this indication, Kadcyla was also granted Breakthrough Therapy Designation.

There was no word on whether Roche was looking to apply for the new indication in other regions.

In the UK the drug faced a long road to market due to one of the bitterest disputes between NICE, the pharma industry and patient groups in recent memory. The three-year row saw NICE accused of stubborn inflexibility, and Roche accused by NICE of setting an outrageously high price for the drug.