Roche moves to broaden Kadcyla use in biosimilar defense

FILE PHOTO – The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann/File Photo

ZURICH (Reuters) – Roche aims to broaden use of its Kadcyla breast cancer drug as the Swiss pharmaceuticals giant defends itself against rivals who are crowding in with cheaper biosimilar copies of its older, patent-expired mainstay Herceptin.

Roche said on Tuesday it submitted an application for the U.S. Food and Drug Administration’s blessing for Kadcyla, a five-year-old drug that carries a killer chemotherapy payload into cancer cells, for post-surgical use in people with a kind of early breast cancer who still showed signs of disease after pre-surgical treatment.

Kadcyla, with 979 million Swiss francs ($981 million) in 2018 sales, is already approved for people with metastatic HER2-positive breast cancer after treatment with Herceptin and chemotherapy.

Roche’s $7 billion-per-year, 21-year-old Herceptin remains the company’s biggest-selling drug, but European sales last year tumbled 16 percent. The company sees possible U.S. competition in the second half of 2019 from rivals including Celltrion and Teva, Pfizer and Mylan.

Expanding use of Kadcyla, which works by attaching Herceptin to a chemotherapy drug developed by ImmunoGen Inc to interfere with cancer cell growth, could help Roche defend its turf in treating women whose cancer contains increased amounts of a protein known as HER2.

“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,” Sandra Horning, Roche’s chief medical officer, said.

At three years, 88.3 percent of people treated with Kadcyla did not have their breast cancer return, according to a clinical study, compared to 77 percent treated with Herceptin.

Reporting by John Miller; Editing by Michael Shields

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