The FDA on March 3, 2023, approved VERZENIO® with endocrine therapy (Tamoxifen or an Aromatase Inhibitor) for the adjuvant treatment of adult patients with Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. VERZENIO® is a product of Eli Lilly and Company.
Category: FDA Approvals
JEMPERLI® (Dostarlimab-gxly)
The FDA on February 9, 2023, approved JEMPERLI® for adult patients with MisMatch Repair deficient (dMMR) recurrent or advanced Endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. JEMPERLI® is a product of GlaxoSmithKline LLC.
TRODELVY® (Sacituzumab Govitecan-hziy)
The FDA on February 3, 2023, approved TRODELVY® for unresectable locally advanced or metastatic Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. TRODELVY® is a product of Gilead Sciences, Inc.
ORSERDU® (Elacestrant)
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.
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.