FDA Approves KEYTRUDA for Stage IIB and IIC Melanoma Patients

Breaking News Melanoma Research


December 4, 2021 (Richmond, California) Yesterday, Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection. The approval is based upon the results of a Phase 3 clinical trial involving 976 newly diagnosed patients in which Keytruda showed a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% compared to placebo alone.

Before this approval, observation was the standard of care for Stage IIB and IIC patients, even though the risk of recurrence for these patients is nearly as high as for patients with Stage IIIA and IIIB disease for whom treatment is recommended. “This approval is a tremendous advancement for patients 12 years and older with Stage IIB and IIC melanoma,” said Dr. Jason Luke, Director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center. “It provides a new option for these patients—one that can help reduce the risk of their melanoma returning.”

Patients will appreciate this new treatment option after a Stage IIB or IIC diagnosis. “Melanoma patients will welcome this treatment option,” said Samantha Guild, President of AIM at Melanoma. “Before yesterday’s approval, a Stage IIB or IIC diagnosis was difficult for patients because they were told they have a high risk of recurrence, yet they were also told there is no effective FDA approved drug treatment available to help reduce their risk. With yesterday’s approval, that situation has changed for this patient population.”

Additionally, Merck also announced that the FDA also expanded the indication for Keytruda as adjuvant treatment for Stage III melanoma following complete resection to include pediatric patients (12 years and older).

Click HERE to read the full press release from Merck.







What is the Standard of Care for Stage II Melanoma Patients in 2022
January 19, 2022, 7:00 PM Eastern Time

Our host of From the Clinic To the Living Room, Melissa Wilson, PA-C, MPAS, Melanoma Lead at UPMC Hillman Cancer Center and AIM’s resident “Ask a Melanoma Expert,” hosts this special presentation with guest, Jason J. Luke, MD, FACP, director, Cancer Immunotherapeutics Center, UPMC Hillman Cancer Center, associate professor of medicine, Division of Hematology/Oncology, University of Pittsburgh School of Medicine, discusses the standard of care for Stage II Melanoma patients in 2022.

– FDA Approval of KEYTRUDA for Stage IIB and IIC Melanoma Patients;
-What did the clinical trial show?
-What does the treatment entail?
– Are there other clinical trials for stage 2B and 2C being done right now?
– How do you determine what is the best option for you?
– A dedicated question-and-answer session during the webinar will provide an opportunity for attendees to converse and ask questions about the FDA approval.