BioBlast®

Merck receives a positive opinion from the EU’s CHMP for an extended indication set for Keytruda® (pembrolizumab). If approved, Keytruda® will also be indicated for metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

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.

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.

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.

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.

Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck’s patents for this product are set to expire in 2028.