The FDA on December 16, 2022, approved ADSTILADRIN® (Nadofaragene firadenovec-vncg) for adult patients with high-risk Bacillus Calmette-Guérin (BCG) unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in Situ (CIS), with or without papillary tumors. ADSTILADRIN® is a product of Ferring Pharmaceuticals.
Category: FDA Approvals
XELODA® (Capecitabine tablets)
The FDA on December 14, 2022, approved updated labeling for XELODA® (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. XELODA® is a product of Genentech, Inc.
KRAZATI® (Adagrasib)
The FDA on December 12, 2022, granted accelerated approval to KRAZATI® (Adagrasib), a RAS GTPase family inhibitor, for adult patients with KRAS G12C-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. KRAZATI® is a product of Mirati Therapeutics, Inc.
TECENTRIQ® (Atezolizumab)
The FDA on December 9, 2022, approved TECENTRIQ® (Atezolizumab) for adult and pediatric patients 2 years of age and older with unresectable or metastatic Alveolar Soft Part Sarcoma (ASPS). TECENTRIQ® is a product of Genentech, Inc.
REZLIDHIA® (Olutasidenib)
The FDA on December 1, 2022, approved REZLIDHIA® (Olutasidenib) capsules for adult patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. REZLIDHIA® is a product of Rigel Pharmaceuticals, Inc.
RYLAZE® (Asparaginase erwinia chrysanthemi recombinant-rywn)
The FDA on November 18, 2022, approved a new Monday-Wednesday-Friday dosing regimen for RYLAZE® (Asparaginase erwinia chrysanthemi recombinant-rywn). 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. RYLAZE® is a product of Jazz Pharmaceuticals.
ELAHERE® (Mirvetuximab soravtansine-gynx)
The FDA on November 14, 2022, granted accelerated approval to ELAHERE® (Mirvetuximab soravtansine-gynx) for adult patients with Folate Receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. ELAHERE® is a Folate Receptor alpha directed antibody and microtubule inhibitor conjugate. Patients are selected for therapy based on an FDA-approved test. ELAHERE® is a product of ImmunoGen, Inc.
IMJUDO® (Tremelimumab)
The FDA on November 10, 2022, approved IMJUDO® (Tremelimumab) in combination with IMFINZI® (Durvalumab) 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. Both IMJUDO® and IMFINZI® are products of AstraZeneca Pharmaceuticals.
ADCETRIS® (Brentuximab vedotin)
The FDA on November 10, 2022, approved ADCETRIS® (Brentuximab vedotin) 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 ADCETRIS®. ADCETRIS® is a product of Seagen, Inc.
LIBTAYO® (Cemiplimab-rwlc)
The FDA on November 8, 2022, approved LIBTAYO® (Cemiplimab-rwlc) in combination with platinum-based chemotherapy for adult patients with advanced Non-Small Cell Lung Cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. LIBTAYO® is a product of Regeneron Pharmaceuticals, Inc.