MD Anderson Cancer Center and BostonGene Corporation formed a strategic alliance to advance the development and clinical integration of multiplatform biomarker signatures.
Jakafi (ruxolitinib) has received FDA approval for treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Cabometyx (cabozantinib) has received FDA approval for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible.
Brukinsa (zanubrutinib) has received FDA accelerated approval for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
The FDA granted accelerated approval to Tivdak (tisotumab vedotin-tftv), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
The FDA authorized the marketing of Paige Prostate, a software program which assists pathologists in the detection of areas that are suspicious for cancer as an adjunct to the review of digitally-scanned slide images from prostate biopsies.
The FDA granted Fast Track designation to CT-0508, a human epidermal growth factor receptor 2 targeted chimeric antigen receptor macrophage for the treatment of patients with solid tumors.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score ≥ 5.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 (Combined Positive Score ≥10) and who have not received prior chemotherapy for metastatic disease.
Exkivity (mobocertinib) was granted FDA accelerated approval for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
