UK’s NICE recommends Roche breast cancer drug Kadcyla

The National Institute for Health and Care Excellence (NICE) in the UK has recommended the use of Roche’s Kadcyla (trastuzumab emtansine) to treat certain patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Kadcyla is an antibody-drug conjugate (ADC) designed to deliver chemotherapy directly to HER2-positive cancer cells and reduce damage to healthy tissues. It received the European Commission approval in December last year.

Roche licenses the technology for the drug as part of an agreement with ImmunoGen.

NICE noted that approximately 7,000 people with early breast cancer have HER2-positive disease each year in England. HER2 is a protein found on the surface of cancer cells and helps them grow and divide.

Kadcyla is a targeted cancer drug. Trastuzumab binds to the HER2 receptor and enables entry of the emtansine into the cancer cell, where it becomes active and destroys the cancer cell.

Data from clinical trial revealed that trastuzumab emtansine improves the time patients remain free of disease compared to trastuzumab alone in people with some cancer cells remaining following chemotherapy and HER2-targeted therapy.

Evidence on trastuzumab emtansine’s ability to increase the length of time patients live is yet to be available.

Kadcyla list price is an average £51,000 per patient for a course of treatment. Roche entered a commercial arrangement to offer the drug to the NHS at an undisclosed discount.

NICE Centre for Health Technology Evaluation deputy chief executive and director Meindert Boysen said: “Additional treatment options that can increase the amount of time in which people remain free of disease after surgery, and perhaps stop it from coming back altogether, are particularly welcome.

“We are therefore pleased to be able to recommend that trastuzumab emtansine is made available routinely for people with HER2-positive early breast cancer after surgery.”

The pricing watchdog will publish its final draft guidance on Kadcyla next month.

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