A Look Back: Novel FDA Approvals in Oncology, 2024

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: Tablets

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 Corp)

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 14, 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. Merus. Published December 4, 2024. Accessed December 5, 2024. https://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. Jazz Pharmaceuticals. Published November 20, 2024. Accessed December 5, 2024. https://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. https://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.prnewswire.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. FDA. 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. FDA. 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-treatment-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. FDA. FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy. Press release. 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 receives FDA approval for Tevimbra for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy. Press release. BeiGene, Ltd. 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.