FDA approves Kadcyla
pharmafile | February 25, 2013 | News story | | Herceptin, Roche, T-DM1
Roche’s new ‘smart bomb’ breast cancer drug Kadcyla has been approved by the FDA, giving it hope of replacing revenue lost by blockbuster Herceptin from 2015.
Kadcyla (trastuzumab emtansine or T-DM1) combines Herceptin and chemotherapy in one molecule and is the first antibody-drug conjugate (ADC) for treating HER2-positive metastatic breast cancer (mBC).
It could make more than $1.1 billion in peak annual sales, analysts say, which would help plug the $6 billion a year set to be eroded by Herceptin’s upcoming patent loss.
Trials have shown Kadcyla significantly delayed disease progression in HER2-positive mBC and produced fewer side effects.
The combination can attach to certain types of cancer cells and deliver chemotherapy directly to them, sparing patients the side-effects of traditional chemo, where healthy cells are also killed.
Kadcyla is thought to block out-of-control signals that make the cancer grow: once it is taken up by the cancer cells, it is designed to destroy them by releasing the DM1.
The Phase III EMILIA study showed Kadcyla reduced the risk of disease worsening or death compared to GlaxoSmithKline’s Tyverb (lapatinib) plus Roche’s Xeloda (capecitabine).
It has been approved by the US regulator for people with HER2-positive mBC who have received prior treatment with Herceptin and a taxane chemotherapy.
The European Medicines Agency is among the international authorities which are also reviewing the new treatment for HER2-positive mBC.
“It helped people in the EMILIA study live nearly six months longer,” explained Hal Barron, Roche’s chief medical officer and head of global product development.
Roche is hoping for great things from ADCs, and has more than 25 in the pipeline, it says, with eight in Phase I or Phase II for different types of cancer.
In EMILIA, patients receiving Kadcyla lived a median of 5.8 months longer than those who received the combination of Tyverb and Xeloda, the current standard of care.
Kadcyla patients also saw a 32% reduction in the risk of dying compared to those in the other treatment arm.
They also lived significantly longer without their disease getting worse, with median progression-free survival of 9.6 months versus 6.4 months.
There were also no safety concerns, with fewer people receiving Kadcyla experiencing severe adverse events than those on Tyverb and Xeloda (43.1% versus 59.2%).
Breast cancer is the most common cancer among women, with 1.4 million new cases diagnosed worldwide, and over 450,000 women dying of the disease annually.
HER2-positive cancer – in which increased quantities of the human epidermal growth factor receptor 2 are present on the surface of tumour cells – is particularly aggressive and affects approximately 15-20% of women with breast cancer.
Adam Hill
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