Keytruda® | Pembrolizumab | Merck

01 Sep 20 | All | NeuClone Pharma | NeuClone Pharmaceuticals discloses it is working on a biosimilar referencing Keytruda® (pembrolizumab). The product is in the advanced stages of pre-clinical development and is being developed in partnership with the Serum Institute of India.

24 Aug 20 | JP | Merck | Merck announces Keytruda® (pembrolizumab) has received two additional approvals from the Japanese Pharmaceuticals and Medical Devices Agency:

• new indication for the treatment of patients whose tumours are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma;

• and an additional dosage regimen of 400mg every six weeks as an IV infusion over 30 minutes, across all adult indications.

19 Aug 20 | All | Merck | Merck announces the results of Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy for first-line treatment of patients with locally advanced or metastatic esophageal cancer. Merck reported that Keytruda® met the primary and secondary endpoints and that the safety profile was consistent with that observed in previously reported studies.

29 Jun 20 | US | Merck | Merck announces the FDA has approved Keytruda® (pembrolizumab) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

14 Feb 18 | All | Celltrion | Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck's patents for this product are set to expire in 2028.