FDA Approves Keytruda as Adjuvant Therapy for Stage IIB/IIC Melanoma, Expanding Access to Earlier-Stage Patients

On December 4, the U.S. FDA announced the approval of MSD's重磅 anti-PD-1 antibody therapy Keytruda as an adjuvant treatment for patients with stage IIB and IIC melanoma (aged 12 and above) who have undergone surgical resection. Previously, Keytruda had already been approved as an adjuvant therapy for patients with stage III melanoma.

This approval is based on positive results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial. In this trial, 976 patients with stage IIB or IIC melanoma received treatment with Keytruda or a placebo after surgical removal of their lesions. At a median follow-up time of 14.4 months, Keytruda reduced the risk of disease recurrence or death by 35% compared to the placebo (HR=0.65, 95% CI: 0.46, 0.92; p=0.0132).

Image Source: MSD Official Website

Patients with stage IIB or IIC melanoma carry deep or ulcerated primary tumors. These patients have the same risk of disease recurrence or death as those with stage IIIA and IIIB melanoma; however, the standard treatment for this patient population was previously observation after surgery.

Using Keytruda for the treatment of patients with earlier-stage cancer is one of MSD's key research and development directions. This year, Keytruda has already received FDA approval as an adjuvant therapy for treating patients with triple-negative breast cancer and renal cell carcinoma.

Note: The original text has been abridged.

References:

[1] FDA Approves Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma. Retrieved December 3, 2021, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-stage-iib-or-iic-melanoma

[2] Keytruda Label. Retrieved December 3, 2021, from https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s112lbl.pdf

[3] ADJUVANT IMMUNOTHERAPY PROLONGS RECURRENCE-FREE SURVIVAL IN RESECTED STAGE II B/C MELANOMA [ESMO CONGRESS 2021 PRESS RELEASE]. Retrieved December 3, 2021, from https://www.esmo.org/newsroom/press-office/adjuvant-immunotherapy-prolongs-recurrence-free-survival-in-resected-stage-ii-b-c-melanoma

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