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FDA Greenlights Merck’s KEYTRUDA® Combined with Chemoradiotherapy for Stage III-IVA Cervical Cancer Treatment

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Merck’s KEYTRUDA (pembrolizumab) in combination with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer has been approved by the FDA. Keytruda combined chemoradiotherapy enhanced progression-free survival relative to placebo in the Phase 3 KEYNOTE-A18 trial, which led to this approval. This is the third FDA-approved cervical cancer indication for KEYTRUDA and the 39th U.S. indication.

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FDA Approves KEYTRUDA® with Chemoradiotherapy for New Stage III-IVA Cervical Cancer Patients

New FIGO 2014 Stage III-IVA cervical cancer patients can now use KEYTRUDA with chemoradiotherapy. KEYTRUDA with chemoradiotherapy may reduce disease progression and death. The approval is important for patient treatment.

Immune-mediated adverse effects of KEYTRUDA can be severe or deadly and affect multiple organ systems and tissues. These side effects can develop during or after KEYTRUDA treatment. Safe use of KEYTRUDA requires early detection and management of these responses.

Dr. Bradley Monk, an oncologist and professor, said the approval of KEYTRUDA combined chemoradiotherapy gives cancer patients a new therapeutic option. Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, noted that KEYTRUDA plus chemoradiotherapy is the first U.S. anti-PD-1 regimen approved for FIGO 2014 Stage III-IVA cervical cancer, regardless of PD-L1 expression.

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FDA Expands KEYTRUDA® Approvals for Cervical Cancer Treatment

Along with this latest approval, KEYTRUDA has two more U.S. cervical cancer indications. These include treating persistent, recurrent, or metastatic cervical cancer patients with PD-L1-expressing tumors in combination with chemotherapy, with or without bevacizumab, or as a single agent with disease progression on or after chemotherapy.

The Phase 3 KEYNOTE-A18 trial (ENGOT-cx11/GOG-3047) examined KEYTRUDA with chemoradiotherapy in 1,060 cervical cancer patients. The experiment improved progression-free and overall survival.

The FDA approval of KEYTRUDA with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer patients is a major advance in treatment that may reduce disease progression and death.

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