Kadcyla launches in UK
pharmafile | February 13, 2014 | News story | Sales and Marketing | CDF, Cancer, Kadcyla, NHS, Roche, breast
Roche’s Kadcyla, indicated to treat an aggressive form of breast cancer, has launched today in the UK.
Kadcyla (trastuzumab emtansine) which was also approved a year ago in the US, combines the manufacturer’s ageing breast cancer brand Herceptin (trastuzumab) and ImmunoGen’s DM1 chemotherapy in one molecule.
Administered intravenously once every three weeks, it is the first antibody-drug conjugate (ADC) for treating HER2-positive metastatic breast cancer.
The antibody, trastuzumab, binds to the HER2-positive cancer cells, and is thought to block signals that make the cancer grow while also mobilising the body’s immune system. Once Kadcyla is absorbed into cancer cells, it releases the DM1 to destroy them.
Roche told Pharmafile that its drug costs around £44,310 per patient. It is used as a treatment until disease progression – the average time to which, in the EMILIA Phase III trial, was 9.6 months.
This price tag may raise eyebrows with NICE, its next port of call for NHS funding in England, as the pricing watchdog has rejected many cancer medicines that cost far less than Kadcyla in the past.
The average cost of the once-weekly regimen of Herceptin is currently £28,000 per patient according to NICE, making Roche’s new medicine much more expensive.
Roche will most likely point to stronger clinical trial data to back up its price, but it will still be a nervy time for the Swiss firm given that NICE did not recommend any cancer medicines for final approval last year.
But at the moment its funding path is clear as earlier this month, Kadcyla was one of three drugs added to the Cancer Drugs Fund – which means it will be, in theory at least, available immediately in England.
The fund provides an additional £200 million a year to enable cancer patients to receive treatments not recommended by NICE, or under appraisal by the watchdog.
The European Medicines Agency has authorised Kadcyla for use in adults who have previously received Herceptin and a taxane, separately or in combination.
The EMILIA study showed Kadcyla reduced the risk of disease worsening or death compared with GlaxoSmithKline’s Tyverb (lapatinib) plus Roche’s Xeloda (capecitabine).
EMILIA showed overall survival (OS) of 30.9 months, compared to 25.1 months for patients treated with that existing combination, while Kadcyla patients experienced median progression-free survival (PFS) of 9.6 months, compared to 6.4 months.
Also, 43.6% of patients responded to treatment with Kadcyla, versus 30.8% treated with Tyverb and Xeloda, while those in the Kadcyla arm reported fewer severe side effects.
“Kadcyla represents a new way of targeting HER2-positive breast cancer, which ultimately means that we could extend patients’ lives compared to existing chemotherapy treatment,” said Paul Ellis, Professor of Cancer Medicine at King’s College London.
“In addition, we should be able to reduce many of the symptomatic side effects associated with standard chemotherapy,” he added.
Kadcyla on its own is indicated for adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin and a taxane, separately or in combination.
Roche is still making money from Herceptin, the NHS approving its new injectable form of the drug last year, potentially slashing treatment times for thousands of patients.
The jab received European regulatory authorisation in September, after a Phase III trial demonstrated comparable effectiveness to intravenously-administered Herceptin.
Adam Hill
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