FDA Grants Accelerated Approval to Zanubrutinib for R/R MZL

On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

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Read BeiGene's announcement.

Posted 9/15/2021

FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia

On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved zanubrutinib for adult patients with Waldenström’s macroglobulinemia.

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Read BeiGene's announcement.

Posted 9/7/2021

FDA Approves Updated Pembrolizumab Indication for UC

New Permanent J-Code for Melphalan Flufenamide

Oncopeptides announces J-code J9247 for Pepaxto^® (melphalan flufenamide) injection, 1mg. This J-code will be effective on October 1, 2021.

FDA Approves Nivolumab for High-Risk Urothelial Carcinoma

On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab—240 mg every two weeks or 480 mg every four weeks—for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or programmed death-ligand 1 (PD-L1) status.

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Posted 8/20/2021

FDA Approves Belzutifan for von Hippel-Lindau Disease-Associted Tumors

On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan, a hypoxia-inducible factor inhibitor, for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.

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Read the Merck announcement.

Posted 8/16/2021

FDA Approves Levnatinib + Pembrolizumab for Advanced RCC

On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib plus pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

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Read the Eisai announcement.

Posted 8/16/2021

FDA Approves Pembrolizumab for High-Risk, Early-Stage TNBC

On July 27, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

Read Merck's announcement.

Posted 7/27/2021

FDA Approves Pembrolizumab + Lenvatinib for Advanced Endometrial Cancer

On July 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. 

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Read the Merck announcement.

Read the Eisai Inc. announcement. 

Posted 7/22/2021

FDA Grants Regular Approval + New Indication to Enfortumab Vedotin-ejfv