Keytruda, First-in-Class Melanoma Drug, Gets Accelerated Approval

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Keytruda (pembrolizumab) approved for the treatment of advanced or unresectable melanoma.
Keytruda (pembrolizumab) approved for the treatment of advanced or unresectable melanoma.

The Food and Drug Administration (FDA) has granted accelerated approval for Keytruda (pembrolizumab; Merck) for the treatment of advanced or unresectable melanoma in patients who are no longer responsive to other drugs.

It is indicated for use after treatment with ipilimumab (Yervoy; Bristol-Myers Squibb). For patients whose tumors express the BRAF V600 mutation, Keytruda is indicated for use after treatment with ipilimumab and a BRAF inhibitor.

Keytruda is the first PD-1 inhibitor approved, which restricts the immune system from attacking melanoma cells. It is designed to block the interaction of PD-1 on T-cells with its ligands, PD-L1 and PD-L2, to reactivate anti-tumor immunity. It exerts dual ligand blockade of the PD-1 pathway.

Keytruda was granted a breakthrough therapy designation, as well as priority review and orphan product designations.

RELATED: Incidence and Recurrence of Melanoma Are Equivalent

Keytruda's efficacy was established in clinical trial subjects (N=173) with advanced melanoma whose disease progressed after prior treatment. All were treated with Keytruda, either at the recommended dose of 2mg/kg or at a higher dose of 10mg/kg.

In the half of the participants who received Keytruda at the recommended dose of 2mg/kg, about 24% demonstrated tumor shrinkage. This effect lasted at least 1.4–8.5 months and continued beyond this period in most patients. A similar percentage of patients had their tumor shrink at the 10mg/kg dose.

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