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Recent and Upcoming Public FDA Oncology Events
April 30, 2026: Oncologic Drugs Advisory Committee. Discussions of NDA 220359 for camizestrant tablets and sNDA 218197/S-004 for capivasertib tablets.
May 6, 2026: Conversations on Cancer: Oncology Nurses - Frontliners in Oncology. Public panel discussion spotlighting the critical role nurses play as frontline professionals in oncology drug development. 3:00 pm-4:00 pm EST.
June 10, 2026: Conversations on Cancer: Patient First = Project Facilitate. Discussion on Project Facilitate, which streamlines access to investigational therapies for patients facing life-threatening cancers. 12:00 pm-1:00 pm EST.
June 12, 2026: Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing. Discussion of the CNPV Pilot Program, including the eligibility criteria, voucher selection processes, sponsor responsibilities, FDA review procedures, and program implementation.
In case you missed it:
December 11, 2025: Conversations on Cancer - Empowered Choices: Perspectives on Cancer Care Decision-Making Among Older Adults
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!
March 25: relacorilant in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
March 20: nivolumab with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).
March 5: teclistamab with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Approved under the Commissioner’s National Priority Voucher pilot program.
February 26: zongertinib for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. Approved under the Commissioner’s National Priority Voucher pilot program.
February 24: encorafenib with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.
February 19: acalabrutinib tablets and capsules with venetoclax for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
February 10: pembrolizumab as well as pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
Interested in learning more? Visit Oncology/Hematologic Malignancies Approvals to search or browse a full list of FDA oncology approvals. You can also take a look at this website How to Use Product Labeling.
Recent FDA Oncology Publications
Considerations for Clinical Trial Design in Relapsed and Refractory Osteosarcoma: An FDA Symposium. Clinical Cancer Research.
Project 5 in 5: Paving the Way for Increasing Pragmatism in Clinical Oncology Trials. JCO Oncology Practice.
FDA Approval Summary: Tarlatamab for the Treatment of Extensive Stage Small Cell Lung Cancer. Clinical Cancer Research.
Emulating Comparative Oncology Trials With Real-World Evidence Studies (ENCORE): Process Development and Methodological Considerations for Oncology Real-World Data. Clinical Pharmacology & Therapeutics.
An FDA analysis of the association of tumor growth rate, overall survival and progression-free survival in patients with metastatic NSCLC. Oncologist.
Adoption and Regional Variation of Prostate-Specific Membrane Antigen Positron Emission Tomography in the United States. JCO Oncology Practice.
FDA Approval Summary: Durvalumab for the Treatment of Adult Patients with Muscle Invasive Bladder Cancer. Clinical Cancer Research.
Oncology Drug Development: Challenges of Increasingly Available Therapies. Journal of Clinical Oncology.
FDA Approval Summary: Pembrolizumab for the Treatment of HER2-Positive Gastric Cancer. Clinical Cancer Research.
A novel real-world data methodology for lymphoma outcome classification: the real-world Lugano study. Journal of Comparative Effectiveness Research.
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval
To view all FDA guidance documents in oncology, visit Oncology Guidance.
Are you interested in a transformative career with FDA Oncology? A career where you will have a meaningful impact on public health while benefiting from personalized professional development and mentorship and have cutting-edge research opportunities? If so, email us at futureofonc@fda.hhs.gov for further information.
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