Keytruda scores EU approval in combination with Inlyta for first-line advanced renal cell carcinoma

pharmafile | September 4, 2019 | News story | Research and Development, Sales and Marketing EU, Europe, MSD, keytruda, pharma, renal cell carcinoma 

The European Commission has awarded yet another authorisation in the region to MSD’s Keytruda, this time in combination with the tyrosine kinase inhibitor Inlyta (axitinib) in the first-line treatment of advanced renal cell carcinoma (RCC).

The ruling was made on the back of Phase 3 data confirming that the combination of Keytruda and Inlyta reduced the risk of death by 47% in RCC patients compared to Pfizer’s Sutent (sunitinib), while also presenting benefit in both progression-free survival and objective response rate.

“Advanced renal cell carcinoma is one of the most lethal types of cancer, with the majority of patients dying within five years of their initial diagnosis,” said Professor Thomas Powles, lead investigator for KEYNOTE-426 and Director of Barts Cancer Centre. “It’s encouraging that we can now offer patients in Europe the Keytruda with axitinib combination as a first-line treatment option.”

MSD’s UK Managing Director Louise Houson also remarked on the ruling: “People with advanced renal cell carcinoma have typically faced poor outcomes in past so it is of paramount importance that we strive to secure the best treatment options. The European Commission’s decision means that we are one step closer for these patients in the UK to have access to Pembrolizumab in combination with axitinib. Pembrolizumab has previously been recommended by NICE across a number of cancer types and MSD is working collaboratively with the Government, NHS and NICE to bring access to patients as rapidly as possible.”

Matt Fellows

Related Content

Merck’s Keytruda approved by EC for gastric cancer

Merck (known as MSD outside of the US and Canada) has announced the approval of …

Merck announces phase 3 LITESPARK-005 trial met primary endpoint

Merck (known as MSD outside of the US and Canada) has shared topline results from …

FDA approves IMIDEX’s AI-powered device VisiRad XR

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …

Latest content