Roche cracks China's ADC market open as Kadcyla scores its first breast cancer OK in the country
Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.
The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.
That’s the same indication Roche scored in Kadcyla’s expanded label at the FDA recently. Since the therapy was first introduced in the US, it has steadily racked up blockbuster sales around the world, surpassing $1 billion in the first nine months of 2019.
As with the other regulators, China’s National Medical Product Administration based their OK on the KATHERINE study, Roche said, which showed that Kadcyla reduced the risk of invasive breast cancer recurrence or death from any cause — a metric known as iDFS — by 50% (p<0.0001) compared to Herceptin. At three years, 88.3% of patients treated with Kadcyla did not see their breast cancer return (by comparison, 77% of those on Herceptin didn’t).
“In May 2019, Kadcyla was approved as an adjuvant treatment for early HER-2 positive breast cancer, and in December it was approved by the EU,” Hong Zhou, Roche’s head of China, noted in a statement. “Thanks to China’s ever increasing speed in new drug review and approval, Kadcyla’s approval timeline in China was basically aligned with the US and Europe.”
In the past decade, China has risen from Roche’s 10th largest market to its second just behind the US, Reuters noted.