Keytruda Receives Two New Approvals in Japan

by Judy Ya-Hsuan Lin
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On August 24th, Merck announced its anti-PD-1 therapy received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency for treating unresectable, advanced or recurrent esophageal squamous cell carcinoma (ESCC).

By Judy Ya-Hsuan Lin

Patients with esophageal cancer, either with squamous cell carcinoma type or adenocarcinoma type, desperately demand more treatment options. Esophageal cancer is challenging to treat and is the seventh most commonly diagnosed cancer globally, resulting in more than 572,000 new cases and approximately 509,000 deaths in 2018. Especially in Japan, over 90% of all esophageal cancers are squamous cell carcinogen type.

Merck’s blockbuster drug, KEYTRUDA (Pembrolizumab), is a humanized monoclonal antibody, that increases the ability of patients’ immune system by inhibiting the interaction between PD-1 and its ligands PD-L1/PD-L2 and activating T lymphocytes to affect the growth of tumor cells. The drug is approved for several indications, and it recently notched two new approvals in Japan.

Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck, said, “We remain committed to improving outcomes for as many patients with cancer as possible, including those with esophageal squamous cell carcinoma, which is a leading cause of cancer-related death in Japan. With today’s approvals, specific patients with esophageal cancer can receive a much-needed new treatment option, and adult patients receiving KEYTRUDA will now have the option of a dosing schedule that reduces how often they are at the clinic for treatment.”

Jannie Oosthuizen, President, MSD Japan, said, “In Japan, more than 90% of esophageal cancers are squamous cell carcinomas. Patients with (the) advanced disease face a poor prognosis and are in critical need of new treatment options. These approvals reinforce our commitment to innovative research that will continue to help more patients with cancer in Japan.”


PMDA Approval

Merck has the most extensive immuno-oncology clinical research program in the pharmaceutical industry. As such, it has already investigated KEYTRUDA under several types of cancer and treatment settings through more than 1,200 trials to help understand how KEYTRUDA benefits and posts any negatives to patients.

With years of research, the results have indicated that KEYTRUDA can treat various areas including the head, neck, digestive organs, and immune cells, such as non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin Lymphoma, urothelial carcinoma, microsatellite instability-high or mismatch repair deficient colorectal cancer, and gastric cancer. The success of KEYTRUDA naturally accompanies some permanent discontinuations of the trials due to strong side-effects percentages in the testing populations. However, the constant narrowing down of KEYTRUDA’s use wins Merck approval from the U.S., Canada, and Japan.

The approval of KEYTRUDA in Japan was based on Phase 3 KEYNOTE-181 trial, in which patients with recurrent or metastatic ESCC demonstrated a higher median overall survival for KEYTRUDA (10.3 months) than for chemotherapy (6.7 months). The combined positive score for KEYTRUDA was greater than 10 as well. The approved, recommended use of dosage, according to the pharmacokinetic modeling and exposure-response analyses are 400 mg every six weeks through intravenous infusion over 30 minutes for adults only. For pediatric use, more research is required because there is limited experience in administering large sample populations to help ascertain the safety and efficacy.

Related Article: Lynparza Notches EU Authorization for BRCA-Mutated Metastatic Pancreatic Cancer



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