FDA Actions in October 2024 Accelerate Oncology Treatment Advances
Key Insights
The FDA granted priority review to fam-trastuzumab deruxtecan-nxki (T-DXd) for HER2 (search)-low/ultra-low breast cancer (search), potentially expanding treatment options for this patient subgroup.
Acalabrutinib (Calquence) was approved for frontline mantle cell lymphoma (search) (MCL), offering a new first-line treatment option for patients with this aggressive lymphoma.
The FDA approved zolbetuximab (Vyloy) for HER2 (search)-negative gastric or gastroesophageal junction adenocarcinoma, marking progress in treating this challenging cancer type.
October 2024 saw significant activity from the FDA in the realm of oncology, marked by approvals, priority reviews, and designations aimed at broadening therapeutic options and improving diagnostics across various cancer types. These actions reflect a commitment to addressing unmet needs and improving outcomes for cancer patients.
Approvals and Priority Reviews
The FDA granted priority review to a supplemental biologics license application for fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) on October 1, 2024, for treating adult patients with unresectable or metastatic HER2 (search)-low or HER2-ultralow breast cancer (search) after at least one endocrine therapy in the metastatic setting. This decision could expand the use of T-DXd to a broader population of breast cancer patients. Acalabrutinib (Calquence) received supplemental approval on October 3, 2024, for the treatment of patients with previously untreated mantle cell lymphoma (search) (MCL), offering a new first-line treatment option. On October 18, 2024, the FDA approved zolbetuximab (Vyloy) as a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2 positive. Asciminib (Scemblix) was granted accelerated approval on October 29, 2024, for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (search) in chronic phase.
Diagnostic Advances
The FDA approved the Cologuard Plus test on October 4, 2024, a noninvasive stool DNA test to screen adults 45 and older at average risk for colorectal cancer (search) (CRC). This approval provides an additional screening option for CRC, potentially improving early detection rates. The Ion Torrent Oncomine Dx Target Test was approved on October 21, 2024, as a companion diagnostic to identify patients eligible for treatment with vorasidenib (Voranigo), targeting IDH (search)-mutant diffuse glioma (search). This approval enables more precise patient selection for targeted therapy.
Designations and Other Actions
Several therapies received designations to expedite their development. VLS-1488 was granted fast track designation on October 2, 2024, for platinum-resistant high-grade serous ovarian cancer (search). Namodenoson (CF102) received orphan drug designation in pancreatic cancer (search) on October 9, 2024. Galinpepimut-S was granted rare pediatric disease designation on October 15, 2024, for pediatric patients with acute myeloid leukemia (search) (AML). LP-184 (STAR-001) received fast track designation on October 15, 2024, for glioblastoma (search). HC-7366 was granted fast track designation on October 23, 2024, for adult patients with relapsed/refractory AML. The FDA also accepted the new drug application for TLX101-CDx (Pixclara; 18F-floretyrosine [18F-FET]) for glioma (search) treatment and granted the application priority review on October 24, 2024. On October 10, 2024, the FDA cleared the investigational new drug application of BL-M11D1 in acute myeloid leukemia (AML).
Expanded Approvals and Submissions
The FDA approved nivolumab (Opdivo) plus chemotherapy for operable non–small cell lung cancer (NSCLC) treatment on October 3, 2024. Inavolisib (Itovebi, previously GDC-0077) plus palbociclib (Ibrance) and fulvestrant received approval on October 10, 2024, for hormone receptor (search)-positive, HER2 (search)-negative, PIK3CA-mutated breast cancer (search). The FDA expanded the approval for Jylamvo, an oral methotrexate solution, to include pediatric patients with acute lymphoblastic leukemia (search) on October 29, 2024. A new drug application for a 3-month depot formulation of leuprolide mesylate (Camcevi) was submitted to the FDA on October 30, 2024. The FDA accepted the new drug application of intravesical mitomycin (UGN-102) for the treatment of low-grade, intermediate-risk non–muscle-invasive bladder cancer (search). Also on October 21, 2024, the FDA accepted the resubmission of a new drug application for the combination of rivoceranib (Apatinib) and camrelizumab (SHR-1210) as a first-line systemic treatment in unresectable or metastatic hepatocellular carcinoma (search).
Regulatory Delay and Safety Warning
The FDA delayed its decision on the supplemental new drug application of sotorasib (Lumakras) plus panitumumab (Vectibix) for chemorefractory metastatic CRC with a KRAS (search) G12C mutation on October 17, 2024. On October 25, 2024, the FDA warned against using BioZorb Markers due to potential adverse effects, following Hologic’s recall of all unused devices.