FDA Approves Two Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma

On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved both nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of programmed death-ligand 1 (PD-L1) status. 

For more information, read Bristol Myers Squibb's announcement.

Posted 5/31/2022

FDA Approves Tisagenlecleucel for R/R Follicular Lymphoma

On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.

For more information, read Novartis' announcement.

Posted 5/31/2022

Fam-Trastuzumab Deruxtecan-Nxki Approved for Patients with HER2+ MBC

Fam-Trastuzumab Deruxtecan-Nxki (Enhertu^®, Daiichi Sankyo, AstraZeneca) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

Read press release. 

Posted 05/17/2022

FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Prostate Cancer

On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. 

Read the FDA announcement.

Read Novartis' announcement.

Posted 3/24/2022

FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma

FDA approves nivolumab and relatlimab-rmbw for melanoma

FDA Approves Olaparib for High-Risk Early Breast Cancer

FDA Approves Nivolumab in Combination for Early-Stage NSCLC

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. 

Read the FDA announcement.

Read Merck's announcement.

Posted 12/6/2021

FDA Approves Daratumumab and Hyaluronidase-fihj in Combination for MM

On November 30, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received one to three prior lines of therapy.

Read the FDA announcement.

Read Janssen, Inc.'s announcement.

Posted 12/2/2021

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.

Read the FDA announcement.

Read Merck's announcement.

Posted 11/18/2021

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 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

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.

Read the FDA announcement.

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.

Read the FDA announcement.

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).

Read the FDA announcement.

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. 

Read the FDA announcement.

Read the Merck announcement.

Read the Eisai Inc. announcement. 

Posted 7/22/2021