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Recent and Upcoming Public FDA Oncology Events
Project Socrates: Educational Opportunities
FDA Oncology offers free educational programs for anyone interested in regulatory science and drug development. Check out the Project Socrates web page for more information.
Oncology Fellowship Program Directors: If you are interested in having FDA Oncology speak at your program, reach out to us at projectsocrates@fda.hhs.
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Recent FDA Oncology Approvals
We've recently approved these oncology products—check the labeling for details on indications, dosages, side effects, trial design, efficacy results, and more!
June 30: allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation with a myeloablative preparative regimen for hematopoietic and immunologic reconstitution and to improve chronic Graft-Versus-Host-Disease survival free in adults with hematologic malignancies.
June 24: sacituzumab govitecan-hziy for two indications in adults with triple-negative breast cancer (TNBC).
June 24: palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
June 12: capivasertib in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.
June 12: belzutifan in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
May 28: durvalumab in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
May 27: pivekimab sunirine-pvzy, a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
May 22: datopotamab deruxtecan-dlnk for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
May 15: fam-trastuzumab deruxtecan-nxki for two separate indications in adults with HER2-positive early-stage breast cancer.
May 15: atezolizumab and atezolizumab and hyaluronidase-tqjs as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.
May 13: oral combination of decitabine and cedazuridine tablets with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
May 13: sonrotoclax, a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
May 8: zenocutuzumab-zbco for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
May 1: vepdegestrant, a heterobifunctional protein degrader, for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Interested in learning more? Tune into our FDA Oncology Podcast. You can also take a look at this website How to Use Product Labeling and find full list of FDA oncology approvals online.
Recent FDA Oncology Publications
Building Capacity for Research on Cancer, Older Adults, and Under-Represented Populations: Methods and Lessons Learned From the Development of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center-Medicare Database. JCO Clin Cancer Inform.
Is Progression-Free Survival 2 Ready for Prime Time in US Food and Drug Administration Regulatory Decision Making? J Clin Oncol.
Rare cancers research: Current state of knowledge and emerging opportunities for prevention and interception. J Natl Cancer Inst.
Selpercatinib and the Crossover Conundrum: Potential Impact of Postprogression Therapies on Overall Survival. J Clin Oncol.
New FDA Guidance Documents in Oncology
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products
To view all FDA guidance documents in oncology, visit Oncology Guidance.
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