The FDA on January 27, 2023, approved ORSERDU® (Elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. ORSERDU® is a product of Stemline Therapeutics, Inc.
Category: FDA Approvals
JAYPIRCA® (Pirtobrutinib)
The FDA on January 27, 2023, granted accelerated approval to JAYPIRCA® for Relapsed or Refractory Mantle Cell Lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. JAYPIRCA® is a product of Eli Lilly and Company.
KEYTRUDA® (Pembrolizumab)
The FDA on January 26, 2023, approved KEYTRUDA® for adjuvant treatment following resection and platinum-based chemotherapy for Stage IB (T2a ≥4 cm), II, or IIIA Non-Small Cell Lung Cancer (NSCLC). KEYTRUDA® is a product of Merck & Co., Inc.
BRUKINSA® (Zanubrutinib)
The FDA on January 19, 2023, approved BRUKINSA® for Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). BRUKINSA® is a product of BeiGene USA, Inc.
TUKYSA® (Tucatinib)
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.
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.