Merck's Keytruda Receives NMPA Approval for New 400mg Every-6-Weeks Dosing Regimen Across All Indications in China

March 19, 2021 /Bio ValleyBIOON/ -- Merck & Co. recently announced that its anti-PD-1 therapy Keytruda (brand name: Keytruda; generic name: pembrolizumab) has been approved by the National Medical Products Administration (NMPA) of China for an additional dosing regimen of 400 mg every six weeks (Q6W). This approval applies to all currently approved indications for Keytruda. The new dosing regimen will help reduce the frequency of treatment for patients and provide physicians with greater flexibility in designing treatment plans.

Following this approval, the recommended dosage of Keytruda for adults in China is 200 mg every three weeks or 400 mg every six weeks, applicable to all currently approved indications:

—Indicated for unresectable or metastatic disease following failure of first-line therapyMelanomatreatment (prior to this approval, the recommended dose for this indication was 2 mg/kg once every 3 weeks);

—The combination of pemetrexed and platinum-based chemotherapy is indicated for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) that is negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK);

——Applicable to PD-L1 testing and assessment approved by the National Medical Products AdministrationTumorFirst-line monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) that is EGFR mutation-negative and ALK-negative, with a Tumor Proportion Score (TPS) ≥1%;

—The combination of carboplatin and paclitaxel is indicated for first-line treatment in patients with metastatic squamous non-small cell lung cancer;

——Monotherapy for assessment via fully validated assaysTumorPD-L1-expressing (Combined Positive Score (CPS) ≥10), previouslyTreatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma who have failed prior systemic therapy;

—Monotherapy for assessment via fully validated assaysTumorFirst-line treatment for patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma expressing PD-L1 (CPS ≥20).

Keytruda belongs to the class of anti-PD-(L)1 tumor immunotherapies, which help detect and combat tumor cells by enhancing the capabilities of the human immune system. Keytruda is an anti-PD-1 therapy that activates potential effects by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2.TumorT lymphocytes of cells and healthy cells. Currently, Keytruda has become a foundational therapy for multiple types of cancer.

Globally, 10 anti-PD-(L)1 therapies have been approved for marketing, with Keytruda leading the pack. Its global sales reached $14.38 billion in 2020, representing a 30% increase from the previous year.

Previously, the pharmaceutical market research firm EvaluatePharma released a report predicting that Keytruda’s sales would reach $24.91 billion in 2026, making it the world’s best-selling drug. Meanwhile, sales of Bristol-Myers Squibb’s anti-PD-1 therapy Opdivo (Opdivo, nivolumab) are also projected to reach $12.677 billion, ranking it as the second best-selling drug globally. (Bioon.com)

Original source: MSD, Bioon