FDA Approves Rituximab + Chemotherapy for Pediatric Cancer Indications

On December 2, 2021, the U.S. Food and Drug Administration approved rituximab in combination with chemotherapy for pediatric patients (greater than or equal to 6 months to less than 18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia. 

Read the FDA announcement.

Posted 12/6/2021

FDA Approves Pembrolizumab for IIB or IIC Melanoma Following Complete Resection

On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda^® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection. 

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Read Merck's announcement.

Posted 12/6/2021

FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

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Read Merck's announcement.

Posted 11/18/2021

FDA Grants Accelerated Approval to Asciminib for Chronic Myeloid Leukemia

On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved asciminib for adult patients with Ph+ CML in chronic phase with the T315I mutation.

Read the FDA announcement.

Read Novartis' announcement.

Posted 11/1/2021

FDA Approves Pembrolizumab Combination for Cervical Cancer

On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. 

Read the FDA announcement.

Read Merck's announcement.

Posted 10/14/2021

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. 

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Read Seagen and Genmab's announcement.

Posted 9/21/2021

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.

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Read Exelixis' announcement.

Posted 9/20/2021

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

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

FDA Approves Updated Pembrolizumab Indication for UC