Merck's Subcutaneous Keytruda Demonstrates Comparable Efficacy in Phase 3 Trial, Aims for Regulatory Approval Amid Competition

Merck has achieved a notable breakthrough with its subcutaneous formulation of Keytruda, which has successfully passed a Phase 3 trial, demonstrating non-inferiority to its intravenous counterpart[1]. This form of administration significantly streamlines the drug delivery process, reducing the time required to merely 2-3 minutes compared to the 30 minutes needed for intravenous infusion, thus increasing patient convenience and accessibility, especially outside urban centers[1]. This achievement is critical as Merck plans to discuss the trial outcomes with regulatory authorities to leverage this form of Keytruda as its patent approaches expiration, allowing it to sustain its competitive advantage in the burgeoning immunotherapy market[2].
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What are the key differences in side effects between the subcutaneous and intravenous versions of Keytruda?
How does Merck plan to price the subcutaneous version of Keytruda compared to the intravenous formulation?
What specific strategies does Merck intend to adopt to expedite the regulatory approval process for the subcutaneous Keytruda?
In what ways are Roche and Bristol Myers Squibb's subcutaneous cancer therapies positioned as competitors to Merck's new formulation?
How might the introduction of a subcutaneous Keytruda influence the overall treatment landscape for cancer patients?