Changes to Ropeginterferon alfa-2b-njft in Updated NCCN Clinical Practice Guidelines

On February 27, PharmaEssentia, announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) have recently been updated to include ropeginterferon alfa-2b-njft, marketed as BESREMi®, as a preferred first-line cytoreductive therapy option for the treatment of adults with symptomatic, low-risk polycythemia vera. 

For more information read the PharmaEssentia announcement.

Posted 3/13/2024

FDA Approves Zanubrutinib for Relapsed or Refractory Follicular Lymphoma

On March 7, the US Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib in combination with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

For more information read the FDA announcement and BeiGene announcement. 

Posted 3/11/2024

FDA Approves Nivolumab + Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma

On March 6, the US Food and Drug Administration (FDA) approved nivolumab in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. 

For more information read the FDA announcement and the Bristol-Myers Squibb announcement. 

Posted 3/11/2024

FDA Approves Inotuzumab Ozogamicin for Pediatric Patients with Acute Lymphoblastic Leukemia

On March 6, the US Food and Drug Administration (FDA) approved inotuzumab ozogamicin for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia. 

For more information read the FDA announcement. 

Posted 3/8/2024 

FDA Approves Amivantamab-vmjw for Non-small Cell Lung Cancer

On March 1, the US Food and Drug Administration (FDA) approved amivantamab-vmjw in combination with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test.

For more information read the FDA announcement and the Janssen announcement. 

Posted 3/8/2024

FDA Approves Osimertinib + Chemotherapy for EGFR-mutated Non-small Cell Lung Cancer

On February 16, the US Food and Drug Administration (FDA) approved osimertinib in combination with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

For more information read the FDA announcement and the AstraZeneca Pharmaceuticals announcement. 

Posted 2/19/2024

FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma

On February 16, the US Food and Drug Administration (FDA) granted accelerated approval to lifileucel, a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.

For more information read the FDA announcement and the Iovance Biotherapeutics, Inc. announcement. 

Posted 2/19/2024

FDA Approves Tepotinib for Metastatic non-small Cell Lung Cancer

On February 15, the US Food and Drug Administration (FDA) granted traditional approval to tepotinib for adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations.

For more information read the FDA announcement.

Posted 2/16/2024

FDA Approves Irinotecan Liposome for First-line Treatment of Metastatic Pancreatic Adenocarcinoma

On February 13, the US Food and Drug Administration (FDA) approved irinotecan liposome in combination with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.

For more information read the FDA announcement.

Posted 2/13/2024

FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma

On January 19, the US Food and Drug Administration (FDA) approved erdafitinib for adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.

For more information read the FDA announcement and the Janssen announcement. 

Posted 1/22/2024

FDA Approves Pembrolizumab + CRT for FIGO 2014 Stage III-IVA Cervical Cancer

On January 12, the US Food and Drug Administration (FDA) approved pembrolizumab with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.

For more information read the FDA announcement and the Merck announcement.

Posted 1/15/2024

FDA Approves Iptacopan for Patients with Paroxysmal Nocturnal Hemoglobinuria

On December 5, the US Food and Drug Administration (FDA) approved iptacopan—offering superior hemoglobin improvement in the absence of transfusions—as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria. 

For more information read the Novartis announcement.

Posted 12/18/2023

FDA Approves Enfortumab vedotin-ejfv + Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer

On December 15, the US Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer. 

For more information read the FDA announcement, Astellas Pharma announcement, and Merck announcement.

Posted 12/18/2023

FDA Approves Belzutifan for Advanced Renal Cell Carcinoma

On December 14, the US Food and Drug Administration (FDA) approved belzutifan for patients with advanced renal cell carcinoma following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

For more information read the FDA announcement and the Merck announcement. 

Posted 12/18/2023

FDA Approves Eflornithine for Adult and Pediatric Patients with HRNB

On December 13, the US Food and Drug Administration (FDA) approved eflornithine to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

For more information read the FDA announcement and the US WorldMeds announcement. 

Posted 12/18/2023 

FDA Approves pirtobrutinib for Chronic Lymphocytic Leukemia + Small Lymphocytic Lymphoma

On December 1, the US Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

For more information read the FDA announcement and the Eli Lilly announcement. 

Posted 12/4/2023

FDA Approves Nirogacestat for Desmoid Tumors

On November 27, the US Food and Drug Administration (FDA) approved nirogacestat for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors.

For more information read the FDA announcement and the SpringWorks Therapeutic announcement. 

Posted 11/28/2023

FDA Approves Capivasertib + Fulvestrant for Breast Cancer

On November 16, the US Food and Drug Administration (FDA) approved capivasertib in combination with fulvestrant for adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with 1 or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least 1 endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

For more information read the FDA announcement and the AstraZeneca announcement. 

Posted 11/17/2023

FDA Approves Pembrolizumab + Chemotherapy for HER2-negative GEJ Junction Adenocarcinoma

On November 16, the US Food and Drug Administration (FDA) approved pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

For more information read the FDA announcement and the Merck announcement.

Posted 11/17/2023

FDA Approves Repotrectinib for ROS1-positive NSCLC

On November 15, the US Food and Drug Administration (FDA) approved repotrectinib for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.