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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, multicente...
food-and-drug-administration

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 resect...
food-and-drug-administration

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 adult...
food-and-drug-administration

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 ...
food-and-drug-administration

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)-positiv...
food-and-drug-administration

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...
food-and-drug-administration

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