The FDA on May 16, 2024, granted accelerated approval to IMDELLTRA® (Tarlatamab-dlle) (Imdelltra, Amgen, Inc.) for Extensive Stage Small Cell Lung Cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA® is a product of Amgen, Inc.
Category: FDA Approvals
BREYANZI® (Lisocabtagene maraleucel)
The FDA on May 15, 2024, granted accelerated approval to BREYANZI® for adults with relapsed or refractory Follicular Lymphoma (FL) who have received two or more prior lines of systemic therapy. BREYANZI® is a product of Juno Therapeutics, Inc.
TIVDAK® (Tisotumab vedotin-tftv)
The FDA on April 29, 2024, granted traditional approval to TIVDAK® for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication. TIVDAK® is a product of Seagen Inc., now a part of Pfizer Inc.
OJEMDA® (Tovorafenib)
The FDA on April 23, 2024, the Food and Drug Administration granted accelerated approval to OJEMDA® (Tovorafenib) for patients 6 months of age and older with relapsed or refractory pediatric Low-Grade Glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. OJEMDA® is a product of Day One Biopharmaceuticals, Inc.
LUTATHERA® (Lutetium Lu 177 dotatate)
The FDA on April 23, 2024, approved LUTATHERA® for pediatric patients 12 years and older with Somatostatin Receptor (SSTR)-positive GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA® received approval for this indication for adults in 2018. LUTATHERA® is a product of Advanced Accelerator Applications USA, Inc., a Novartis company.
ANKTIVA® (nogapendekin alfa inbakicept-pmln)
The FDA on April 22, 2024, the Food and Drug Administration approved ANKTIVA® with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in Situ (CIS) with or without papillary tumors. ANKTIVA® is a product of Altor BioScience, LLC.
ALECENSA® (Alectinib)
The FDA on April 18, 2024, approved ALECENSA® for adjuvant treatment following tumor resection in patients with Anaplastic Lymphoma Kinase (ALK)-positive Non-Small Cell Lung Cancer (NSCLC), as detected by an FDA-approved test. ALECENSA® is a product of Genentech, Inc.
ENHERTU® (fam-Trastuzumab Deruxtecan-nxki)
The FDA on April 5, 2024, granted accelerated approval to ENHERTU® for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. ENHERTU® is a product of Daiichi Sankyo, Inc.
ELAHERE® (Mirvetuximab soravtansine-gynx)
The FDA on March 22, 2024, approved ELAHERE® (Mirvetuximab soravtansine-gynx) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Patients are selected based on an FDA-approved test. ELAHERE® is a product of ImmunoGen, Inc. [now a part of AbbVie]).
ICLUSIG® (Ponatinib)
The FDA on March 19, 2024, granted accelerated approval to ICLUSIG® (Ponatinib) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). ICLUSIG® is a product of Takeda Pharmaceuticals U.S.A., Inc.