USFDA sends CRL to Merck’s sBLA regarding KEYTRUDA

Merck has announced that the US Food and Drug Administration (FDA) has sent a Complete Response Letter (CRL) regarding Merck’s supplemental Biologics License Application (sBLA) for the approval of KEYTRUDA.

KEYTRUDA or pembrolizumab is the American multinational pharmaceutical giant’s anti-PD-1 therapy, used to treat patients with high-risk early-stage triple-negative breast cancer (TNBC), in combination with chemotherapy as pre-operative (neoadjuvant) treatment, following it up as a single agent treatment after surgery.

The letter is under review and Merck plans to discuss subsequent steps with the FDA.

The application was submitted on the basis of pCR data along with early interim event-free survival (EFS) findings from the Phase 3 KEYNOTE-522 trial. The trial continues to evaluate for EFS.

Prior to the Prescription Drug User Fee Act (PDUFA) action date for the application, the FDA’s Oncologic Drugs Advisory Committee voted 10-0 regarding deferral of a regulatory decision until the availability of further data from KEYNOTE-522.

The calendar-driven next interim analysis will be held in the third quarter of 2021.

However, the CRL by USFDA has no effect on any current approved indications for KEYTRUDA, which includes the indication for KEYTRUDA when combined with chemotherapy to treat patients with locally recurrent unresectable or metastatic TNBC, whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test.

This indication has been approved through accelerated approval on the basis of progression-free survival. Continued approval may depend upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA (pembrolizumab) 100 mg injection is an anti-PD-1 therapy, which enhances the ability of a body’s immune system to detect and fight tumour cells.

Merck has the largest immuno-oncology clinical research programme in the pharma industry.

Currently, there are over 1,400 trials studying KEYTRUDA’s potential benefits across various cancers and treatment settings.