November 2024 FDA Updates: Key Developments in Oncology

November 2024 was a significant month for the FDA, with numerous approvals, designations, and clinical trial advancements in the oncology space.

Notably, the FDA approved revumenib (SNDX-5613) in KMT2A-rearranged acute leukemia and obecabtagene autoleucel (obe-cel; Aucatzyl) as a treatment for adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).

In the realm of immunotherapy, the combination of RP1 (vusolimogene oderparepvec) and nivolumab (Opdivo) for advanced melanoma was submitted to the FDA for accelerated approval. The FDA also granted fast track designation toa number of agents, including ALE.P02 for patients with Claudin-1-positive squamous solid tumors.

For solid tumors, the FDA cleared a phase 1 trial of BL-M17D1 in advanced solid tumors, and granted orphan drug designation to LBL-024 for neuroendocrine cancer. In the realm of hematologic malignancies, elraglusib received orphan drug designation from the FDA for the potential treatment of Ewing sarcoma.

Here is a look back on all the FDA happenings from the month of November 2024.

FDA Clears Phase 2 Trial of Leronlimab for Microsatellite-Stable CRC

The FDA gave clearance for the commencement of a phase 2 trial evaluating the efficacy of leronlimab for the treatment of patients with relapsed/refractory microsatellite stable colorectal cancer on November 4, 2024.

FDA Pushes Zenocutuzumab Decision Date in NGR1+ NSCLC, PDAC

On November 5, 2025, the FDA announced that the Prescription Drug User Fee Act (PDUFA) for the biologics license application seeking the approval of zenocutuzumab (MCLA-128) for patients with NRG1-positive non–small cell lung cancer (NSCLC) and pancreatic cancer has been extended.

FDA Grants Orphan Drug Designation to LBL-034 in Multiple Myeloma

LBL-034 received orphan drug designation from the FDA on November 6, 2024, for the treatment of patients with multiple myeloma.

MB-108 Gains FDA Orphan Drug Status for Malignant Glioma Treatment

The FDA granted orphan drug designation to MB-108 for the treatment of patients with malignant glioma on November 7, 2024.

Sunvozertinib New Drug Application in EGFR-Mutant NSCLC Submitted to FDA

A new drug application for sunvozertinib in relapsed/refractory NSCLC with EGFR exon 20 insertion mutations was submitted to the FDA on November 8, 2024.

FDA Greenlights Obe-cel in Relapsed/Refractory B-ALL

On November 8, 2024, the FDA approved obe-cel (Aucatzyl) as a treatment for adult patients with relapsed/refractory B-cell ALL.

FDA Grants Clearance for Phase 1 Trial of BL-M17D1 in Solid Tumors

On November 8, 2024, the FDA also cleared an investigational new drug application for BL-M17D1 in advanced or metastatic solid tumors.

Elraglusib Gains FDA Rare Pediatric Disease Designation in Ewing Sarcoma

Elraglusib was granted rare pediatric disease designation from the FDA for the treatment of patients with Ewing sarcoma on November 12, 2024.

FDA OKs Study of Amezalpat in Frontline Liver Cancer

The FDA approved a “Study May Proceed” letter to evaluate amezalpat (formerly TPST-1120) with atezolizumab (Tecentriq) and bevacizumab (Avastin) in a phase 3 trial for patients with unresectable or metastatic hepatocellular carcinoma, also on November 12, 2024.

FDA Approval Sought for Dato-DXd in EGFR-Mutated NSCLC

On November 12, 2024, a new biologics license application was submitted specifically for EGFR-mutated NSCLC after FDA feedback, replacing the earlier nonsquamous NSCLC application.

FDA Approves IND for AS1986NS, a New Approach in Prostate Cancer Research

The investigational new drug application for AS1986NS, a novel prostate cancer diagnostic and treatment agent, received FDA approval on November 12, 2024.

FDA Clears Spectral 4DCT for Precision in Radiation Oncology

Also on November 12, 2024, the FDA granted 510(k) clearance to Philips Spectral computed tomography 7500 RT.

FDA Approves Nilotinib With No Mealtime Restrictions in Ph-Positive CML

The FDA granted approval to nilotinib (Danziten) on November 14, 2024, for the treatment of adult patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase and adult patients with chronic phase and acute phase.

FDA Approves Revumenib in KMT2A-Rearranged Acute Leukemia

Revumenib (SNDX-5613) was approved by the FDA for patients with relapsed/refractory KMT2A-rearranged acute leukemia on November 15, 2024.

ALE.P02 Gains FDA Fast Track Status in CLDN1+ Solid Tumors

On November 18, 2024, the FDA granted fast track designation to ALE.P02 for treating patients with Claudin-1-positive squamous solid tumors.

FDA Updates Fludarabine Labeling Under Project Renewal Initiative

The FDA approved an updated drug labeling for fludarabine phosphate (fludarabine phosphate injection) under Project Renewal on November 19, 2024.

FDA Receives BLA for RP1 and Nivolumab Combo in Advanced Melanoma

On November 21, 2024, a biologics license application seeking the accelerated approval of RP1 (vusolimogene oderparepvec) plus nivolumab (Opdivo) in adult patients with advanced melanoma who have received previous treatment with a regimen containing a PD-1 inhibitor was submitted to the FDA.

LBL-024 Gains FDA Orphan Drug Status in Neuroendocrine Cancer

The FDA granted LBL-024 orphan drug designation for the treatment of neuroendocrine cancer on November 22, 2024.

FDA Approves First Oral Liquid Imatinib for Leukemia and Other Cancers

The FDA approved imatinib oral solution (Imkeldi) on November 25, 2024, for the treatment of certain forms of leukemia and other cancers.

FDA Accepts BLA for Belantamab Mafodotin Combinations in R/R Multiple Myeloma

On November 25, 2024, the FDA accepted a biologics license application for belantamab mafodotin (Blenrep) in combination with bortezomib (Velcade) and dexamethasone, as well as with pomalidomide (Pomalyst) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior line of therapy.

FDA Approves HER2 Test as Companion Diagnostic for Zanidatamab in Biliary Tract Cancer

PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody was approved by the FDA on November 25, 2024, as a companion diagnostic for zanidatamab-hrii (Ziihera) to assess HER2-positive status in patients with biliary tract cancer.

FDA Grants Fast Track Designation to LBS-007 in AML

The FDA granted LBS-007 fast track designation for the treatment of patients with acute myeloid leukemia on November 27, 2024.