Tumor immunotherapy! Mersadon Keytruda has two new approvals in Japan: esophageal cancer, a 6-week drug administration program!

August 25, 2020 // --- Merck and Co recently announced that the anti-PD-1 therapy Keytruda (Corida, generic name: pembrolizumab, Pabliju monotherapy) has received two new approvals from the Japan Medicines and Medical Devices Authority (PMDA): (1) Keytruda as a single drug therapy For the treatment of patients with progression after chemotherapy, positive expression of tumor PD-L1, complete inability to remove, advanced or relapsed esophageal squamous cell carcinoma (ESCC);
, Keytruda has been approved in Japan for 13 therapeutic adaptations, including 7 types of tumors and MSI-H tumors.
addition to the current 200mg dose programme every 3 weeks (Q3W), the approved Q6W 400mg scheme will provide patients with a new dosing option.
"We remain committed to improving the prognostics of as many cancer patients as possible, including esophageal squamous cell carcinoma, which is the leading cause of cancer-related deaths in Japan," said Dr. Jonathan Cheng, Vice President of Oncology Clinical Research at Mercado Research Laboratory.
with today's approval, specific esophageal cancer patients have access to much-needed new treatment options, while adult patients treated with Keytruda can now opt for a dosing program to reduce the frequency with which they go to the clinic.
"PDMA approves Keytruda for the treatment of certain ESCC patients based on the results of the Global Phase 3 KEYNOTE-181 trial.
data show that in patients with relapsed or metastasis ESCC with tumor expression PD-L1 (CPS-10), Keytruda single-drug treatment was extended compared to chemotherapy (yew alcohol, dosi yew alcohol, or elytecon) Lifetime (mid OS: 10.3 months vs 7.6 months), reducing the risk of death by 36% (HR=0.64 (95% CI: 0.46-0.90)).
PDMA approved keytruda Q6W administration, based on pharmacodynamic models and exposure reaction analysis.
pharmacodynamic model data are supported by an interim analysis of KEYNOTE-555 pharmacodynamics, efficacy, and safety data from the patient queue (queue B) treated with Keytruda 400mg Q6W.
more than 90 percent of esophageal cancer in Japan is squamous cell carcinoma," said Jannie Oosthuizen, president of Merca East Japan, which has been linked to esophageal cancer (Photo: Medscape.com).
patients with advanced diseases have poor prognostics and are in urgent need of new treatment options.
these approvals reinforce our commitment to innovative research that will continue to help more cancer patients in Japan.
" in China, Keytruda was approved in June 2020 as a single-drug therapy for the treatment of patients with local late stage or metastatic esophageal squamous cell carcinoma (ESCC) who had failed previous system therapy treatments and tumor expression PD-L1 (combined positive score of (CPS) of 10).
With this new approval, Keytruda is now approved in China for five adaptations to three different types of cancer, including first-line therapy (single-drug therapy and combination chemotherapy) for patients with advanced non-small cell lung cancer (NSCLC) and second-line therapy for advanced melanoma.
specifically: (1) for the treatment of non-removable or metastasis melanoma after first-line treatment failure; (2) first-line treatment for metastasis and platinum chemotherapy for EGFR/ALK gene mutation-negative metastasis NSCLC; (3) for tests approved by NMPA as PD-L1 expression positive (TPS -1%) And EGFR/ALK gene mutation negative local late stage or metastasis NSCLC first-line single-drug treatment; (4) combined carbapton and yew alcohol suitable for metastasis squamous NSCLC first-line treatment; (5) as a single drug therapy, used to treat the failure of previous system therapy treatment, tumor expression PD-L1 (CPS-10) local late stage or metastasis ESCC patients.
esophageal cancer is a particularly difficult cancer to treat, starting from the inner esophageal layer (mucous membranes) to grow outwards.
there are two main types of esophageal cancer: squamous cell carcinoma and adenocarcinoma.
, 90% of esophageal cancers are squamous cell carcinomas.
, esophageal cancer is the seventh most commonly diagnosed cancer.
estimates that in 2018, there will be more than 572,000 new cases of esophageal cancer worldwide and nearly 509,000 deaths.
, esophageal cancer is the fifth most common cancer and the fourth most common cause of death.
keytruda is a PD-(L)1 tumor immunotherapy that helps detect and fight tumor cells by improving the body's immune system.
Keytruda is an anthogeneic monoclonal antibody that blocks the interaction between PD-1 and its mediators PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells.
So far, more than 10 PD-(L)1 oncology immunotherapy treatments have been approved worldwide, with Keytruda leading the field, with more than 20 therapeutic adaptations approved, and global sales of $11.1 billion in 2019, up 58% from the previous year.
has the largest clinical development program in the industry for immuno-oncology, and more than 1,200 clinical trials are currently investigating Keytruda's role in multiple types of tumors and treatment backgrounds.
Keytruda Clinical Program aims to understand the role of the drug in cancer and the factors that may predict patients to benefit from Keytruda treatment, including exploring several different biomarkers.
() Original source: Merck's KEYTRUDA® Receives Two New approvals in Japan.