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FDA Expands Cetuximab in Combination Label for Metastatic Colorectal Cancer
On September 28, 2021, the U.S. Food and Drug Administration (FDA) granted approval of a new indication for cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Read Eli Lilly's announcement.
Posted 9/29/2021
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FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Cervical Cancer
On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Read the FDA announcement.
Read Seagen and Genmab's announcement.
Posted 9/21/2021
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FDA Approves Cabozantinib for Locally Advanced or Metastatic DTC
On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible.
Read the FDA announcement.
Read Exelixis' announcement.
Posted 9/20/2021
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FDA Approves Mobocertinib for NSCLC with EGFR Exon 20 Insertion Mutations
On September 15, 2021, the U.S. Food and Drug Administration (FDA) approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Read the FDA announcement.
Read Takeda's announcement.
Posted 9/16/2021
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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.
Read the FDA announcement.
Read BeiGene's announcement.
Posted 9/15/2021
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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.
Read the FDA announcement.
Read BeiGene's announcement.
Posted 9/7/2021
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FDA Approves Updated Pembrolizumab Indication for UC
On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved a label update to pembrolizumab for first-line advanced urothelial carcinoma (UC). This approval converts the accelerated approval of pembrolizumab to a regular approval.
Read Merck's announcement.
Posted 9/1/2021
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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.
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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.
Read the FDA announcement.
Posted 8/20/2021
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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.
Read the FDA announcement.
Read the Merck announcement.
Posted 8/16/2021