Keytruda has received two approvals from the Japan Pharmaceuticals and Medical Devices Agency.
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.
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.
Foundation Medicine Inc. is partnering with Epic to integrate its comprehensive genomic profiling and other testing services with Epic’s electronic medical record system.
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.
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.
A supplemental New Drug Application for Cabometyx (cabozantinib) was granted FDA priority review as a treatment for patients 12 years and older with differentiated thyroid cancer who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate).
Bristol Myers Squibb has withdrawn the U.S. indication for Istodax for relapsed/refractory peripheral T-cell lymphoma.
Keytruda (pembrolizumab) received FDA approval for high-risk, early-stage, triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
