FDA has accepted for review a supplemental Biologics License Application seeking approval for Keytruda as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.Â
FDA has accepted and granted priority review to the New Drug Application for asciminib (ABL001) in chronic myeloid leukemia.Â
The European Commission has granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.Â
Keytruda has received two approvals from the Japan Pharmaceuticals and Medical Devices Agency.Â
The European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for both Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.Â
The European Commission has granted orphan drug designation to sabatolimab (MBG453) for the treatment of myelodysplastic syndromes, based on clinical data showing a high rate of responses in patients with high-risk MDS who were treated with sabatolimab in combination with hypomethylating agents.Â
Foundation Medicine Inc. is partnering with Epic to integrate its comprehensive genomic profiling and other testing services with Epic’s electronic medical record system.Â
Werewolf Therapeutics Inc. has entered into a clinical trial collaboration and supply agreement with Merck to evaluate WTX-124, a systemically-delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE product candidate, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.Â
The European Commission has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
FDA has accepted the Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer whose tumors express PD-L1≥1%, as determined by an FDA-approved test.
