Reflecting on Progress: Novel FDA Approvals in Oncology Across 2024

FDA Updates
January 2025 Vol 16, No 1

In 2024, the FDA approved an impressive array of new therapies, diagnostic tools, and indications, offering new hope to many people with cancer.

Bizengri (zenocutuzmab-zbco, Merus)

Class/route: Administer as an intravenous infusion, after dilution, over 4 hours
Indication: To treat non–small cell lung cancer and pancreatic adenocarcinoma
Approval date: December 4, 20241

Ziihera (zanidatamab-hrii, Jazz Pharmaceuticals)

Class/route: Injection
Indication: To treat unresectable or metastatic HER2-positive (IHC3+) biliary tract cancer
Approval date: November 20, 20242

Revuforj (revumenib, Syndax)

Class/route: Tablet
Indication: To treat relapsed or refractory acute leukemia
Approval date: November 15, 20243

Vyloy (zolbetuximab-clzb, Astellas)

Class/route: Use in combination with fluoropyrimidine- and platinum-containing chemotherapy
Indication: To treat gastric or gastroesophageal junction cancer
Approval date: October 18, 20244

Itovebi (inavolisib, Genentech)

Class/route: Tablet
Indication: To treat locally advanced or metastatic breast cancer
Approval date: October 10, 20245

Lazcluze (lazertinib, Janssen Biotech, Inc)

Class/route: EGFR inhibitor/oral
Indication: To treat non–small cell lung cancer
Approval date: August 19, 20246

Voranigo (vorasidenib, Servier)

Class/route: IDH1 and IDH2 inhibitor/oral
Indication: Grade 2 astrocytoma or oligodendroglioma
Approval date: August 6, 20247

Rytelo (imetelstat, Geron)

Class/route: Telomerase inhibitor/intravenous
Indication: To treat low- to intermediate-1 risk myelodysplastic syndromes
Approval date: June 6, 20248

Imdelltra (tarlatamab-dlle, Amgen)

Class/route: DLL3-targeting BiTE therapy/intravenous
Indication: To treat extensive-stage small cell lung cancer
Approval date: May 16, 20249

Anktiva (nogapendekin alfa inbakicept-pmln, ImmunityBio, Inc)

Class/route: IL-15 receptor agonist/intravenous
Indication: Bladder cancer
Approval date: April 22, 202410

Lumisight (pegulicianine, Lumicell)

Class/route: Imaging tool/used with fluorescence imaging device
Indication: To use as an optical imaging agent for detecting cancerous tissue following lumpectomy
Approval date: April 17, 202411

Tevimbra (tislelizumab-jsgr, BeiGene)

Class/route: Checkpoint inhibitor/intravenous
Indication: To treat unresectable or metastatic esophageal squamous cell carcinoma
Approval date: March 13, 202412

References

  1. Merus. Merus announces FDA approval of Bizengri (zenocutuzumab-zbco) for NRG1+ pancreatic adenocarcinoma and NRG1+ non–small cell lung cancer (NSCLC) based on safety and efficacy data from the eNRGy study. Press release. December 4, 2024. Accessed December 5, 2024. www.globenewswire.com/news-release/2024/12/04/2991955/37568/en/Merus-Announces-FDA-Approval-of-BIZENGRI-zenocutuzumab-zbco-for-NRG1-Pancreatic-Adenocarcinoma-and-NRG1-Non-Small-Cell-Lung-Cancer-NSCLC-Based-on-Safety-and-Efficacy-Data-From-the-.html
  2. Jazz Pharmaceuticals. Jazz Pharmaceuticals announces US FDA approval of Ziihera (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). Press release. November 20, 2024. Accessed December 5, 2024. www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-approval-of-ziihera-zanidatamab-hrii-for-the-treatment-of-adults-with-previously-treated-unresectable-or-metastatic-her2-positive-ihc-3-biliary-tract-cancer-btc-302312216.html
  3. Syndax. Syndax announces FDA approval of Revuforj (revumenib), the first and only menin inhibitor to treat adult and pediatric patients with relapsed or refractory acute leukemia with a KMT2A translocation. Press release. November 15, 2024. Accessed December 5, 2024. www.prnewswire.com/news-releases/syndax-announces-fda-approval-of-revuforj-revumenib-the-first-and-only-menin-inhibitor-to-treat-adult-and-pediatric-patients-with-relapsed-or-refractory-acute-leukemia-with-a-kmt2a-translocation-302307513.html
  4. Astellas Pharma Inc. Astellas’ Vyloy (zolbetuximab-clzb) approved by US FDA for treatment of advanced gastric and GEJ cancer. Press release. October 18, 2024. Accessed November 4, 2024. www.prnews wire.com/news-releases/astellas-vyloy-zolbetuximab-clzb-approved-by-us-fda-for-treatment-of-advanced-gastric-and-gej-cancer-302280716.html
  5. Genentech. FDA approves Genentech’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. Press release. October 10, 2024. Accessed November 4, 2024. www.businesswire.com/news/home/20241008295168/en/FDA-Approves-Genentech%E2%80%99s-Itovebi-a-Targeted-Treatment-for-Advanced-Hormone-Receptor-Positive-HER2-Negative-Breast-Cancer-With-a-PIK3CA-Mutation
  6. Food and Drug Administration. FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer. Press release. August 19, 2024. Accessed September 20, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer
  7. Food and Drug Administration. FDA approves vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation. Press release. August 6, 2024. Accessed October 14, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma-susceptible-idh1-or-idh2-mutation
  8. Geron Corporation. Geron announces FDA approval of Rytelo (imetelstat), a first-in-class telomerase inhibitor, for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia. Press release. June 6, 2024. Accessed September 20, 2024. https://ir.geron.com/investors/press-releases/press-release-details/2024/Geron-Announces-FDA-Approval-of-RYTELO-imetelstat-a-First-in-Class-Telomerase-Inhibitor-for-the-Treatment-of-Adult-Patients-with-Lower-Risk-MDS-with-Transfusion-Dependent-Anemia/default.aspx
  9. Amgen. FDA approves Imdelltra, the first and only T-cell engager therapy for the treatment of extensive stage small cell lung cancer. Press release. May 16, 2024. Accessed September 20, 2024. www.amgen.com/newsroom/press-releases/2024/05/fda-approves-imdelltra-tarlatamabdlle-the-first-and-only-tcell-engager-therapy-for-the-treat ment-of-extensivestage-small-cell-lung-cancer
  10. ImmunityBio. ImmunityBio announces FDA approval of Anktiva, first-in-class IL-15 receptor agonist for BCG-unresponsive non-muscle invasive bladder cancer. Press release. April 22, 2024. Accessed September 20, 2024. https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/
  11. Food and Drug Administration. FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy. April 17, 2024. Accessed October 14, 2024. www.fda.gov/drugs/news-events-human-drugs/fda-approves-imaging-drug-assist-detection-cancerous-tissue-following-lumpectomy
  12. BeiGene, Ltd. BeiGene receives FDA approval for Tevimbra for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy. News release. March 14, 2024. Accessed September 14, 2024. https://ir.beigene.com/news/beigene-receives-fda-approval-for-tevimbra-for-the-treatment-of-advanced-or-metastatic-esophageal-squamous/20eb032c-15ce-456a-a852-39c88a28d811/

Editor’s note: This listing and references are current as of December 4, 2024. They were generated partially using artificial intelligence- assistance.

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