The FDA has handed Merck another potential runway for its blockbuster drug KEYTRUDA, granting priority review to two new applications targeting bladder cancer.
On Monday, Merck announced the FDA accepted two supplemental Biologics License Applications for KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph). Both are being reviewed in combination with Padcev (enfortumab vedotin-ejfv) for patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy.
The FDA has set a Prescription Drug User Fee Act target action date of August 17, 2026.
Priority review status is reserved for drugs that may offer meaningful improvements in treating serious conditions. It typically shortens the review timeline to about six months, compared to the standard ten months.
The applications are backed by data from the Phase 3 KEYNOTE-B15 trial. That study showed improved survival outcomes in patients with muscle-invasive bladder cancer when treated with the KEYTRUDA plus Padcev combination.
Merck did not release specific trial data in Monday’s announcement, but the FDA’s decision to grant priority review signals the agency sees the data as potentially practice-changing.
The current approved use of KEYTRUDA plus Padcev covers adult patients with locally advanced or metastatic urothelial cancer in the U.S., the European Union, Japan, and several other countries.
This new application would expand that footprint into an earlier stage of the disease — the muscle-invasive setting — where treatment intent is often curative.
If approved, the KEYTRUDA and KEYTRUDA QLEX combinations with Padcev would become the first perioperative treatments for MIBC patients regardless of cisplatin eligibility.
That’s a meaningful distinction. Currently, the combination is approved for MIBC patients who are ineligible for cisplatin-based chemotherapy. The new applications would extend coverage to those who are eligible — broadening the potential patient pool.
Perioperative treatment refers to therapy given around the time of surgery, which is standard of care for muscle-invasive bladder cancer. Getting into that setting with a priority review label puts Merck in a strong regulatory position heading into the August decision date.
KEYTRUDA QLEX is a subcutaneous formulation of pembrolizumab, meaning it can be delivered by injection under the skin rather than via intravenous infusion. That could offer convenience benefits over the standard IV administration.
Merck’s stock was up 3.13% on Monday as the news crossed. The August 17 target date now becomes a key watch point for investors tracking the company’s oncology pipeline.
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