Eli Lilly and Company, FDA, Food and Drug Administration, Jaypirca, Mantle cell lymphoma, MCL, pirtobrutinib
Accelerated approval is granted by FDA to pirtobrutinib for relapsed or refractory mantle cell lymphoma
Feb 2023: Accelerated approval is granted by FDA to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma. In BRUIN (NCT03740529), an open-label, multicenter, single-arm trial of pirtobr..
FDA, Food and Drug Administration, KEYTRUDA, Merck, Pembrolizumab, platinum-based chemotherapy
Pembrolizumab is approved by FDA as adjuvant treatment for non-small cell lung cancer
Feb 2023: For stage IB (T2a 4 cm), stage II, or stage IIIA non-small cell lung cancer, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) as adjuvant therapy after resection and platinum-based chemoth..
cGVHD, Food and Drug Administration, Incyte Corp, Jakafi, Ruxolitinib
Ruxolitinib is approved for chronic graft-versus-host disease
October 2021: After failure of one or two lines of systemic therapy, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host disease (cGVHD) in adults and children aged 12 and up...
FDA, Food and Drug Administration, NCT03438396, tisotumab vedotin-tftv, Tivdak
Tisotumab forvedotin-tftv is approved for recurrent or metastatic cervical cancer
October 2021: The FDA has given tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor combination, rapid approval for adult patients with recurrent or metastatic cervical cancer ..
anaplastic lymphoma kinase, B7461006, CDx Assay, Food and Drug Administration, Lorbrena, lorlatinib, NCT03052608, NSCLC, Pfizer, Ventana ALK, Ventana Medical Systems
Lorlatinib has been approved by the FDA for the treatment of metastatic ALK-positive NSCLC
August 2021: Lorlatinib (Lorbrena, Pfizer Inc.) received regular FDA approval for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive, as determined by an FDA-app..
cemiplimab-rwlc, EGFR, FDA, Food and Drug Administration, NCT03088540, NSCLC, PD-L1 expression
Cemiplimab-rwlc has been approved by the FDA for non-small cell lung cancer with high PD-L1 expression
August 2021: The FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgic..