FDA's October 2024 Highlights: Advancing Treatments in Oncology
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.
FDA Grants Priority Review to T-DXd for HR+, HER2-Low/Ultralow Breast Cancer
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.
VLS-1488 Gains FDA Fast Track Status in Advanced Ovarian Cancer
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.
Acalabrutinib Receives FDA Priority Review in Frontline MCL
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.
FDA Approves Perioperative Nivolumab in Resectable NSCLC
Also on October 3, 2024, the FDA approved nivolumab (Opdivo) plus chemotherapy for operable non–small cell lung cancer (NSCLC) treatment.
FDA Approves Cologuard Plus Stool DNA Test for Colorectal Cancer Screening
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.
Namodenoson Earns FDA Orphan Drug Designation in Pancreatic Cancer
The FDA granted orphan drug designation to namodenoson (CF102) in pancreatic cancer on October 9, 2024.
FDA Approves Inavolisib Plus Standard Therapy in PIK3CA-Mutant Breast Cancer
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.
Cancer cells, 3D illustration: © Dr_Microbe - stock.adobe.com
FDA Clears IND of Novel ADC in AML Treatment
October 10, 2024, the FDA cleared the investigational new drug application of BL-M11D1 in acute myeloid leukemia (AML).
FDA Provides Positive Feedback on AMPLIFY Trial for Prostate Cancer Diagnostic
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.
FDA OKs Optune Lua for Use With PD-1/PD-L1 Inhibitors in Metastatic NSCLC
The FDA approved Optune Lua on October 15, 2024, in metastatic NSCLC following platinum-based regimen progression.
FDA Clears NDA of Intravesical Mitomycin in Non–Muscle-Invasive Bladder Cancer
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.
FDA Grants Rare Pediatric Disease Designation to Galinpepimut-S in AML
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.
LP-184 Earns FDA Fast Track Designation in Glioblastoma
The FDA granted fast track designation to LP-184 (STAR-001) for the treatment of glioblastoma, also on October 15, 2024.
DNA Molecule : © ktsdesign - stock.adobe.com
FDA Pushes Back Decision on Sotorasib/Panitumumab in Colorectal Cancer
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.
Zolbetuximab Scores FDA Approval in CLDN 18.2+ Gastric/GEJ Cancer
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.
FDA Approves Companion Diagnostic for Vorasidenib in IDH-Mutant Glioma
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.
FDA Accepts NDA Resubmission of Rivoceranib and Camrelizumab in HCC
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.
FDA Fast Tracks HC-7366 in Relapsed/Refractory Acute Myeloid Leukemia
The FDA has granted fast track designation to HC-7366 for the treatment of adult patients with relapsed/refractory AML on October 23, 2024.
FDA Grants Priority Review for TLX101-CDx PET Imaging Agent in Glioma
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.
FDA Issues Warning on BioZorb Markers After Recall Due to Patient Complications
On October 25, 2024, the FDA warned against using BioZorb Markers due to potential adverse effects, following Hologic’s recall of all unused devices.
FDA Expands Approval for Jylamvo Oral Methotrexate Solution in ALL
The FDA expanded the approval for Jylamvo, an oral methotrexate solution, to include pediatric patients with acute lymphoblastic leukemia on October 29, 2024.
FDA Approves Asciminib in Newly Diagnosed Ph+ CML in Chronic Phase
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.
Ready-to-Use 3-Month Leuprolide Depot Formulation Nears FDA Approval
A new drug application for a 3-month depot formulation of leuprolide mesylate (Camcevi) has been submitted to the FDA on October 30, 2024.
Therapy Type and Site of Metastases Factor into HR+, HER2+ mBC Treatment
December 20th 2024During a Case-Based Roundtable® event, Ian Krop, MD, and participants discussed considerations affecting first- and second-line treatment of metastatic HER2-positive breast cancer in the first article of a 2-part series.
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Ilson Examines Chemoimmunotherapy Regimens for Metastatic Gastroesophageal Cancers
December 20th 2024During a Case-Based Roundtable® event, David H. Ilson, MD, PhD, discussed the outcomes of the CheckMate 649, CheckMate 648, and KEYNOTE-859 trials of chemoimmunotherapy regimens in patients with upper GI cancers.
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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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Advancing Neoadjuvant Therapy for HER2+ Breast Cancer Through ctDNA Monitoring
December 19th 2024In an interview with Targeted Oncology, Adrienne Waks, MD, provided insights into the significance of the findings from the DAPHNe trial and their clinical implications for patients with HER2-positive breast cancer.
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