The FDA on January 19, 2023, granted accelerated approval to TUKYSA® in combination with Trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following Fluoropyrimidine, Oxaliplatin, and Irinotecan-based chemotherapy. TUKYSA® is a product of Seagen Inc.
Category: FDA Approvals
LUNSUMIO® (Mosunetuzumab-axgb)
The FDA on December 22, 2022 granted accelerated approval to LUNSUMIO®, a bispecific CD20-directed CD3 T-cell engager for adult patients with Relapsed or Refractory Follicular Lymphoma (FL) after two or more lines of systemic therapy. LUNSUMIO® is a product of Genentech, Inc.
LUNSUMIO® (Mosunetuzumab-axgb)
The FDA on December 22, 2022, granted accelerated approval to LUNSUMIO® (Mosunetuzumab-axgb), a bispecific CD20-directed CD3 T-cell engager for adult patients with Relapsed or Refractory Follicular Lymphoma (FL) after two or more lines of systemic therapy. LUNSUMIO® is a product of Genentech, Inc.
ADSTILADRIN® (Nadofaragene firadenovec-vncg)
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.
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.