Drugs

The FDA approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the first drug to receive a labeling update under this pilot program. Read More.

Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs’ labeling up to date, while providing transparency on FDA’s deliberative evaluation process and evidentiary standards, and improving awareness of drug labeling as an information resource for healthcare providers.

U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI™ (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Read More. 

Food and Drug Administration (FDA) approved atezolizumab (Tecentriq, Genentech, Inc.) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). Read more.

Rigel Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved REZLIDHIA™ (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. REZLIDHIA is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells. Read More. 

FDA approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours at a dose of 25 mg/m2 intramuscularly.  Read More.

The Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen, Inc.) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for brentuximab vedotin. Read More.

The Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Read More. 

Food and Drug Administration approved LIBTAYO® (cemiplimab-rwlc)  (Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.  Read More. 

Please see additional Important Safety Information below and the full LIBTAYO Prescribing Information here or go to www.libtayohcp.com.

Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Read More.

Food and Drug Administration approved IMJUDO® (tremelimumab-actl), (AstraZeneca Pharmaceuticals) in combination with IMFINZI® (durvalumab) for adult patients with unresectable hepatocellular carcinoma (uHCC). Read More. 

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. You may report side effects related to AstraZeneca products by clicking here.