MSD aims to get the jump on BMS treating bladder cancer

pharmafile | February 6, 2017 | News story | Manufacturing and Production, Sales and Marketing BMS, Bristol-Myers Squibb, MSD, keytruda, opdivo 

Bristol-Myers Squibb’s Opdivo was only just approved for second-line treatment of bladder cancer, but MSD has attempted to have its own drug, Keytruda, leapfrog them with by having it accepted for priority review in both first and second-line treatments.

MSD have applied for Keytruda to be used in the treatment of patients suffering from locally advanced or metastatic urothelial carcinoma, the most common form of bladder cancer. The indication for first-line treatment would be targeting those patients who are unable to undergo cisplatin-containing therapy. While the treatment, in a second-line setting, would be in those patients who had experienced disease progression after or during platinum-containing chemotherapy.

“Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer,” said Dr. Roger Dansey, Senior Vice President and Therapeutic Area Head of Oncology Late-Stage Development, Merck Research Laboratories. “The data with Keytruda administered to patients with advanced urothelial cancer are promising, and we look forward to working with the FDA throughout the review process with the goal of bringing Keytruda to patients who may benefit as quickly as possible.”

The data is based upon two trials, one Phase 2 and one Phase 3 trial, that met their co-primary endpoint of extending overall survival. The indications for Keytruda are likely to come thick and fast, with the drug going through 400 clinical trials for over 30 tumour types.

Both Keytruda and Opdivo are lagging behind Roche’s Tecentriq, which has been already approved in second-line treatment and has been accepted for priority review from the FDA for first-line treatment in January of this year.

A decision will be reached on the two indications by 14 June of this year.

Ben Hargreaves

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