Reblozyl (luspatercept) has received approval from the European Commission for the treatment of:
Guardant Health Inc. launched the GuardantINFORM platform, which includes a clinical-genomic liquid biopsy dataset of advanced cancer patients.
Keytruda was approved by FDA for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.
Selinexor (Xpovio) was granted accelerated approval from FDA for adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
Myovant Sciences' New Drug Application for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by FDA.
Keytruda was approved by the National Medical Products Administration in China as monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by a fully validated test, following failure of one prior line of systemic therapy.
Keytruda was approved by FDA as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
FoundationOne CDx has received FDA approval as a companion diagnostic for Keytruda (pembrolizumab), Merck's anti-PD-1 therapy.
Lurbinectedin (Zepzelca) was granted accelerated approval by FDA for adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy.
Gemtuzumab ozogamicin (Mylotarg) was granted an extended indication by FDA for newly-diagnosed CD33-positive acute myeloid leukemia to include pediatric patients 1 month and older.
