The FDA on June 6, 2024, approved RYTELO® an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk MyeloDysplastic Syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks, who have not responded to, or have lost response to, or are ineligible for Erythropoiesis-Stimulating Agents (ESAs). RYTELO® is a product of Geron Corporation.
Category: FDA Approvals
BREYANZI® (Lisocabtagene maraleucel)
The FDA on May 30, 2024, approved BREYANZI® for adult patients with relapsed or refractory Mantle Cell Lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton Tyrosine Kinase Inhibitor (BTKi). BREYANZI® is a product of Juno Therapeutics, Inc.
RETEVMO® (Selpercatinib)
The FDA on May 29, 2024, granted accelerated approval to RETEVMO® (Selpercatinib) for pediatric patients two years of age and older with RET-altered metastatic thyroid cancer or solid tumors. RETEVMO® is a product of Eli Lilly and Company.
IMDELLTRA® (Tarlatamab-dlle)
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.
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.