EMA gives positive opinion for Keytruda combination
EMA has decided on a positive opinion for a new combo of MSD’s cancer blockbuster, Keytruda (pembrolizumab) and Inlyta (axitinib).
The organisation’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of the anti-PD-1 therapy and Inlyta combo, a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
The recommendation applies to all IMDC risk groups and is based on findings from the pivotal Phase III KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for the combo compared to sunitinib.
“For patients with advanced renal cell carcinoma, the prognosis is poor, with a five-year survival rate of less than 10%,” said Dr Scot Ebbinghaus, vice president, clinical research, MSD Research Laboratories.
He added “The positive opinion adopted by the EMA, which is based on data showing Keytruda in combination with axitinib significantly improved overall survival regardless of PD-L1 expression, is an important step toward a new first-line treatment option for these patients.”
The data were presented for the first time at the 2019 Genitourinary Cancers Symposium (ASCO GU) and published in The New England Journal of Medicine. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorisation in the European Union, and a final decision is expected in the third quarter of 2019.
RCC is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are renal cell carcinomas, and it is about twice as common in men as in women. Modifiable risk factors include smoking, obesity, workplace exposure to certain substances and high blood pressure.