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On April 4, 2024, the FDA approved idecabtagene vicleucel (ide-cel; Abecma, Bristol Myers Squibb) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial. Read More
On April 5, 2024, the FDA granted approval to ciltacabtagene autoleucel (cilta-cel; CARVYKTI) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide based on the CARTITUDE-4 study. CARVYKTI is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse. Read More
On April 5, 2024, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2+ (IHC3+) solid tumors after prior treatment and no satisfactory alternative treatment options. Approval was based on the DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 trials. Read More
On April 18, 2024, the FDA approved alectinib (Alecensa) as an adjuvant treatment following tumor resection for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) whose tumors are at least 4 cm or node positive, as detected by an FDA-approved test based on the phase 3 ALINA trial. Read More
On April 22, 2024, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) 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 based on the phase 2/3 QUILT-3.032 trial. Read More
On April 23, 2024, the FDA approved lutetium Lu 177 dotatate (177Lu-Dotatate; Lutathera) for the treatment of pediatric patients 12 and older with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) based on the NETTER-P study. 177Lu-Dotatate is the first radioactive drug approved for the treatment of patients 12 and older with SSTR-positive GEP-NETs. Read More
On April 23, 2024, the FDA approved tovorafenib (DAY101), an oral, type II RAF kinase inhibitor that targets a key enzyme in the MAPK signaling pathway, for relapsed or progressive pediatric low-grade glioma (pLGG) supported by findings from the phase 2 FIREFLY-1 trial. Read More
On April 29, 2024, the FDA granted full approval to tisotumab vedotin (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy based on the innovaTV 301 trial. Read More
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