Here is a look back on all the FDA happenings from the month of October 2024.
October 2024 brought a number of significant FDA actions across oncology, focusing on new approvals, priority reviews, and designations aimed at broadening therapeutic options and improving diagnostics across cancer types.
Some highlights include the FDA’s priority review for fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in HER2-low/ultra-low breast cancer, the approval of acalabrutinib (Calquence) for frontline mantle cell lymphoma (MCL) treatment, and the introduction of Cologuard Plus for noninvasive colorectal cancer (CRC) screening.
Here’s a summary of the key FDA updates from this month, relevant to oncology practice.
Here is a look back on all the FDA happenings from the month of October 2024.
On October 1, 2024, the FDA granted a priority review designation to a supplemental biologics license application for T-DXd for the treatment of adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer after at least 1 endocrine therapy in the metastatic setting.
Fast track designation was granted to VLS-1488 by the FDA on October 2, 2024, for the treatment of platinum-resistant high-grade serous ovarian cancer.
The FDA granted the supplemental new drug application of acalabrutinib priority review for the treatment of patients with previously untreated MCL on October 3, 2024.
Also on October 3, 2024, the FDA approved nivolumab (Opdivo) plus chemotherapy for operable non–small cell lung cancer (NSCLC) treatment.
The FDA approved the Cologuard Plus test, a noninvasive stool DNA test to screen adults 45 and older at average risk for CRC, on October 4, 2024.
The FDA granted orphan drug designation to namodenoson (CF102) in pancreatic cancer on October 9, 2024.
The FDA granted approval to inavolisib (Itovebi, previously GDC-0077) plus palbociclib (Ibrance) and fulvestrant for the treatment of hormone receptor-positive, HER2-negative, PIK3CA-mutated breast cancer on October 10, 2024.
October 10, 2024, the FDA cleared the investigational new drug application of BL-M11D1 in acute myeloid leukemia (AML).
On October 14, 2024, it was announced that a phase 3 trial of the 64Cu-SAR-bisPSMA diagnostic in patients with biochemical recurrence of prostate cancer plans to initiate.
The FDA approved Optune Lua on October 15, 2024, in metastatic NSCLC following platinum-based regimen progression.
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.
Rare pediatric disease designation has been granted to galinpepimut-S on October 15, 2024, by the FDA for the treatment of pediatric patients with AML.
The FDA granted fast track designation to LP-184 (STAR-001) for the treatment of glioblastoma, also on October 15, 2024.
On October 17, 2024, the FDA announced that it delayed its decision on the supplemental new drug application of sotorasib (Lumakras) plus panitumumab (Vectibix) for the treatment of chemorefractory metastatic CRC with a KRAS G12C mutation.
The FDA approved zolbetuximab (Vyloy) on October 18, 2024, as a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2 positive.
The Ion Torrent Oncomine Dx Target Test was approved as a companion diagnostic to identify patients eligible for treatment with vorasidenib (Voranigo), targeting IDH-mutant diffuse glioma on October 21, 2024.
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.
The FDA has granted fast track designation to HC-7366 for the treatment of adult patients with relapsed/refractory AML on October 23, 2024.
On October 24, 2024, the FDA accepted the new drug application for TLX101-CDx (Pixclara; 18F-floretyrosine [18F-FET]) for glioma treatment and granted the application priority review.
On October 25, 2024, the FDA warned against using BioZorb Markers due to potential adverse effects, following Hologic’s recall of all unused devices.
The FDA expanded the approval for Jylamvo, an oral methotrexate solution, to include pediatric patients with acute lymphoblastic leukemia on October 29, 2024.
Accelerated approval was granted to asciminib (Scemblix) by the FDA on October 29, 2024, for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
A new drug application for a 3-month depot formulation of leuprolide mesylate (Camcevi) has been submitted to the FDA on October 30, 2024.
Navigating ESR1 Mutations in HR-Positive Breast Cancer With Dr Wander
October 31st 2024In this episode of Targeted Talks, Seth Wander, MD, PhD, discusses the clinical importance of ESR1 mutations in HR-positive metastatic breast cancer and how these mutations influence treatment approaches.
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