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.

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.

FDA Approves Fruquintinib in Refractory Metastatic Colorectal Cancer

On November 8, the US Food and Drug Administration (FDA) approved fruquintinib for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

For more information read the FDA announcement.

Posted 11/9/2023

FDA Approves Pembrolizumab with Chemotherapy for Biliary Tract Cancer

On October 31, the US Food and Drug Administration (FDA) approved pembrolizumab to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer. 

For more information read the FDA announcement and Merck announcement. 

Posted 11/1/2023

FDA Approves Toripalimab-tpzi for Nasopharyngeal Carcinoma

On October 27, the US Food and Drug Administration (FDA) approved toripalimab-tpzi in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. The FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy.

For more information read the FDA announcement and the Coherus BioSciences announcement. 

Posted 11/1/2023

FDA Approves Ivosidenib for Myelodysplastic Syndromes

On October 24, the US Food and Drug Administration approved ivosidenib for adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test.

For more information read the FDA announcement.

Posted 10/27/2023

FDA Expands Pediatric Indication for Entrectinib and Approves New Pellet Formulation

On October 20, 2023, the US Food and Drug Administration (FDA) granted accelerated approval to entrectinib for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory standard therapy.

For more information read the FDA announcement.

Posted 10/20/2023