MSD’s two filings for Keytruda’s use in bladder cancer treatment have been accepted by the US FDA and given priority review status. 

The first filing is for Keytruda’s use as a first-line treatment in patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin treatment. The second filing is for Keytruda’s use as a second-line therapy in patients whose cancers have progressed during or after platinum-based chemotherapy.

The second filing is for Keytruda’s use as a second-line therapy in patients whose cancers have progressed during or after platinum-based chemotherapy.

Both applications have a target action date of June 14 this year.

In each setting, MSD is seeking approval for Keytruda as a 200mg, intravenous monotherapy administered every three weeks. The FDA’s granting of priority review for both filings was based on data from the phase 2 KEYNOTE-052 and the phase 3 KEYNOTE-045 studies.

In the KEYNOTE-052 trial, Keytruda’s use as a second-line therapy for those who cannot receive cisplatin-containing treatment resulted in a 24% overall response rate. The KEYNOTE-045 showed a significant improvement in overall survival in those patients taking Keytruda as a second-line therapy.

“Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer,” said Roger Dansey, senior vice president and therapeutic area head of oncology late-stage development at 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.”

If given full FDA approval, Keytruda’s list of approved indications will grow to six – the same as its major PD-1 inhibitor rival, Bristol Myers-Squibb’s Opdivo. Keytruda had previously been granted breakthrough therapy designation as a second-line treatment of patients with bladder cancer whose disease progressed on or after platinum-containing chemotherapy.

Opdivo is still currently leading in indications following its own approval in second-line bladder cancer for use after failure of platinum-based chemotherapy or in those patients with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Opdivo is still currently leading in indications following its own approval in second-line bladder cancer for use after failure of platinum-based chemotherapy or in those patients with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Both drugs are being investigated in numerous other cancer indications as both monotherapies and as part of combination approaches. Keytruda itself is being investigated in 27 trials.

Opdivo does, however, have a distinct feature giving it an edge over Keytruda: it is approved in bladder cancer patients regardless of their PD-L1 status. This means more patients will be eligible for Opdivo treatment than MSD’s alternative.

Advertisements