March Roundup of FDA Approvals in Oncology: 4 Decisions to Know

Below is your guide to all the oncologic options that were approved, rejected, or withdrawn by the FDA in March 2026. The regulatory roundup provides everything you need to know, right at your fingertips—all the topline data that supported the decisions and expert insights detailing clinical practice implications.

3/5: Teclistamab Plus Subcutaneous Daratumumab in Relapsed/Refractory Multiple Myeloma

Indication: The FDA approved teclistamab-cqyv (Tecvayli) in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro) for use in adult patients with relapsed/refractory multiple myeloma who have previously received at least 1 line of therapy. The agency also converted the prior accelerated approval of single-agent teclistamab in this setting to traditional status.¹

Supporting Data: The decision was based on data from the phase 3 MajesTEC-3 trial (NCT05083169), which enrolled patients who had received 1 to 3 prior lines of therapy.² At a median follow-up of 34.5 months, the median progression-free survival (PFS) was not reached (95% CI, not evaluable [NE]-NE) with teclistamab plus daratumumab (n = 291) vs 18.1 months (95% CI, 14.6-22.8) with investigator’s choice of daratumumab and hyaluronidase-fihj, pomalidomide (Pomalyst) and dexamethasone or daratumumab and hyaluronidase-fihj, bortezomib (Velcade) and dexamethasone (n = 296; HR, 0.17; 95% CI, 0.12-0.23; P < .0001). The respective objective response rates were 89.0% (95% CI, 84.8%-92.4%) vs 75.3% (95% CI, 70.0%-80.1%), complete response or better rates were 81.8% (95% CI, 76.9%-86.0%) vs 32.1% (95% CI, 26.8%-37.7%), and minimal residual disease (MRD) negativity rates were 58.4% (95% CI, 52.2%-64.4%) and 17.1% (95% CI, 12.8%-22.1%). A significant overall survival (OS) benefit was also observed with the teclistamab combination (HR, 0.46; 95% CI, 0.32-0.65; P < .0001). The safety profile was consistent with the known profiles of each agent; cytokine release syndrome occurred in 60.1% of patients but was predominantly grade 1, with no grade 3 or higher effects reported.

Clinical Significance: This approval establishes teclistamab plus daratumumab as a potent bispecific antibody–based combination option earlier in the multiple myeloma treatment continuum, delivering deep and durable responses, including high rates of MRD negativity, compared with standard doublet regimens. The concurrent conversion of the monotherapy approval to traditional status further solidifies the role of teclistamab in the relapsed/refractory setting.

“This new treatment option can redefine how we approach relapsed/refractory multiple myeloma treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile,” Luciano J. Costa, MD, professor of multiple myeloma and director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham, and primary investigator of MajesTEC-3, stated in a news release.³ “The option to use this regimen as early as second line is particularly important because patients with relapsed/refractory multiple myeloma often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical. In addition, the steroid-sparing approach may reduce toxicity and improve tolerability.”

OTHER RELATED COVERAGE

• Findings from the MajesTEC-3 trial presented at the 2025 ASH Annual Meeting and Exposition showed that teclistamab plus daratumumab and hyaluronidase-fihj significantly improved OS and PFS compared with standard daratumumab-based regimens in patients with relapsed/refractory multiple myeloma who had received 1 to 3 prior lines of therapy.⁴
• In a past interview with OncLive®, Peter Forsberg, MD, of Colorado Blood Cancer Institute, discussed how the MajesTEC-3 trial data could affect the management of relapsed/refractory multiple myeloma.⁵
• In a past Peer Exchange program, a panel of experts including Ajai Chari, MD, PhD; Krina K. Patel, MD, MSc; Cristina Gasparetto, MD; Rafael Fonseca, MD; and Omar Nadeem, MD, unpacked patient selection and combining therapies as it relates to teclistamab in multiple myeloma.⁶

3/6: Pylarify TruVu for PSMA-PET Imaging in Prostate Cancer

Indication: The FDA cleared Pylarify TruVu (piflufolastat F 18) injection for PET imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or with suspected recurrence based on elevated serum prostate-specific antigen levels.⁷

Supporting Data: The application was filed via the 505(b)(2) pathway, leveraging findings from the phase 2/3 OSPREY trial (NCT02981368) and phase 3 CONDOR trial (NCT03739684), which previously supported the 2021 approval of the original Pylarify formulation.⁸ In OSPREY, piflufolastat F 18 PET/CT demonstrated significantly higher specificity than standard imaging (97.9% vs 65.1%) and nearly triple the positive predictive value (86.7% vs 28.3%) in patients with high-risk prostate cancer prior to initial therapy. In CONDOR, the agent achieved a correct localization rate of 85% to 87% across readers in patients with biochemically recurrent disease, meeting the trial's primary end point.⁷ The safety profile was favorable, with headache, dysgeusia, and fatigue among the most common adverse reactions.

Clinical Significance: Pylarify TruVu carries the same diagnostic properties as the original Pylarify formulation but is engineered for greater stability at higher radioactive concentrations, allowing more efficient manufacturing, larger batch sizes, and broader geographic distribution. This decision may address a key access gap for a proven and widely used PSMA PET imaging agent, with meaningful implications for timely and accurate staging and restaging of prostate cancer across a wider range of clinical settings.

In an exclusive interview with OncLive, Xiao Wei, MD, MAS, of Dana-Farber Cancer Institute and Harvard Medical School, unpacked the clinical significance of the decision:⁹

3/20: Nivolumab Plus AVD in Untreated Classical Hodgkin Lymphoma

Indication: The FDA cleared nivolumab (Opdivo) plus doxorubicin, vinblastine, and dacarbazine (AVD) for the treatment of adult and pediatric patients aged 12 years and older with previously untreated, stage III or IV classical Hodgkin lymphoma.¹⁰ The agency also granted regular approval to nivolumab for relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin (Adcetris; BV), or following at least 3 prior lines of systemic therapy, including autologous HSCT.

Supporting Data: The decision was based on findings from the phase 3 Study CA209-8UT/SWOG 1826 (NCT03907488). At a median follow-up of 13.7 months, the median PFS was not reached in either arm, with outcomes significantly favoring nivolumab plus AVD over brentuximab vedotin/AVD (HR, 0.42; 95% CI, 0.27-0.67; P < .0001). The complete metabolic response rate per investigator assessment was 79% (95% CI, 75%-83%) in the nivolumab/AVD arm vs 64% (95% CI, 60%-69%) in the BV/AVD arm.¹¹ After a median follow-up of 36.7 months, the median OS had not been reached in either arm; a total of 26 deaths occurred in the AVD arm, and 17 deaths occurred in the BV/AVD arm. The rate of serious adverse effects (AEs) with nivolumab/AVD was 39%, and immune-mediated AEs of any grade occurred in 9% of patients.

Clinical Significance: This approval introduces the first immunotherapy combination cleared for adult and pediatric patients aged 12 years and older with previously treated, stage III or IV classical Hodgkin lymphoma.¹²

OTHER RELATED COVERAGE

• In a past Blood Club podcast episode, Matthew Lunning, DO, FACP, of the University of Nebraska Medical Center sat down with Alex Herrera, MD, of City of Hope, to discuss the frontline management of Hodgkin lymphoma, in which they highlighted the rationale for and potential implications of the phase 3 SWOG 1826 trial.¹³
• In another exclusive interview with OncLive, Jakub Svoboda, MD, of the Hospital of the University of Pennsylvania, Penn Medicine, unpacked the implications of SWOG 1826 examining nivolumab plus AVD in patients with advanced classical Hodgkin lymphoma.¹⁴

3/25: Relacorilant Plus Nab-Paclitaxel in Platinum-Resistant Ovarian Cancer

Indication: The FDA approved relacorilant (Lifyorli) paired with nab-paclitaxel (Abraxane) for use in adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens, at least 1 of which included bevacizumab (Avastin).¹⁵

Supporting Data: The decision was based on data from the phase 3 ROSELLA trial (NCT05257408). Patients who received relacorilant plus nab-paclitaxel (Abraxane; n = 188) achieved a median PFS of 6.5 months (95% CI, 5.6-7.4) vs 5.5 months (95% CI, 3.9-5.9) with nab-paclitaxel alone (HR, 0.70; 95% CI, 0.54-0.91; P = .0076), and a median OS of 16.0 months (95% CI, 13.0-18.3) vs 11.9 months (95% CI, 10.0-13.8), respectively (HR, 0.65; 95% CI, 0.51-0.83; P = .0004). The most common AEs included decreased hemoglobin and neutrophil levels, fatigue, nausea, and diarrhea.

Clinical Significance: Relacorilant plus nab-paclitaxel represents the first approved glucocorticoid receptor modulator–based regimen in oncology and was studied in a biomarker-unselected population, making it broadly accessible to eligible patients with platinum-resistant disease.¹⁷

In an exclusive interview with OncLive, Alexander B. Olawaiye, MD, of the University of Pittsburgh Medical Center, discussed updated OS data from ROSELLA:¹⁸

OTHER RELATED COVERAGE

• In January 2026, it was announced that relacorilant plus nab-paclitaxel significantly improved OS compared with nab-paclitaxel alone in patients with platinum-resistant ovarian cancer, meeting the co-primary end point of ROSELLA.¹⁹
• In October 2025, a marketing authorization application for the use of relacorilant in patients with platinum-resistant ovarian cancer was submitted to the European Medicines Agency.²⁰
• In a past interview with OncLive,²¹ Domenica Lorusso, MD, PhD, of Humanitas University, explained the impetus for evaluating relacorilant plus nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer in ROSELLA.²²
• In a past News Network program, Tara Berman, MD, MS, and Gottfried E. Konecny, MD, discussed data for relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer enrolled in ROSELLA.²³

Other Noteworthy Decisions

• The FDA issued a complete response letter for a supplemental biologics license application seeking the approval of retifanlimab-dlwr (Zynyz) injection in combination with platinum-containing chemotherapy for the treatment of adult patients with metastatic non–small cell lung cancer.²⁴
• On March 2, 2026, the FDA granted tentative approval to the abbreviated new drug application (ANDA) for PNT2003—a lutetium lu 177 dotatate (Lutathera) radioequivalent—for use in patients with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.²⁵
• On March 9, 2026, it was announced that the FDA indications for tazemetostat (Tazverik) for the treatment of patients with relapsed or refractory follicular lymphoma and those with epithelioid sarcoma were being voluntarily withdrawn by the agent’s developer, Ipsen.²⁶
• On March 18, 2026, the regulatory agency cleared the MyChoice CDx Test as the companion diagnostic for determining whether patients with advanced ovarian cancer may be eligible to receive treatment with niraparib (Zejula).²⁷
• On March 30, 2026, The FDA cleared denosumab-adet (Ponlimsi) as a biosimilar to denosumab (Prolia) for all indications of the reference product.²⁸

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References

1. FDA grants third approval under the national priority voucher program. FDA. March 5, 2026. Accessed March 31, 2026. https://www.fda.gov/news-events/press-announcements/fda-grants-third-approval-under-national-priority-voucher-program
2. Tecvayli. Prescribing information. Janssen Biotech, Inc; 2026. Accessed March 31, 2026. https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf
3. Johnson & Johnson announces US FDA approval of Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma, offering a potential new standard of care as early as second line. News release. March 5, 2026. Accessed March 31, 2026. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-tecvayli-plus-darzalex-faspro-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care-as-early-as-second-line
4. Mateos M-V, Bahlis N, Perrot A, et al. Phase 3 randomized study of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or Bortezomib (DPd/DVd) in patients (Pts) with relapsed refractory multiple myeloma (RRMM): Results of majestec-3. Blood. 2025;146(suppl 2): LBA-6. doi:10.1182/blood-2025-LBA-6
5. Forsberg P. Dr Forsberg on the impact of the MajesTEC-3 trial in relapsed/refractory myeloma. OncLive.com. December 16, 2025. Accessed March 31, 2026. https://www.onclive.com/view/dr-forsberg-on-the-impact-of-the-majestec-3-trial-in-relapsed-refractory-myeloma
6. Chari A, Patel KK, Gasparetto C, et al. Teclistamab in RRMM: Patient selection and combining therapies. OncLive.com. July 28, 2022. Accessed March 31, 2026. https://www.onclive.com/view/teclistamab-in-rrmm-patient-selection-and-combining-therapies
7. Lantheus announces FDA approval of Pylarify TruVu (piflufolastat F 18) injection. News release. Lantheus Holdings, Inc. March 6, 2026. Accessed March 31, 2026. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-approval-pylarify-truvutm-piflufolastat-f
8. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. News release. Lantheus Holdings, Inc. May 27, 2021. Accessed March 31, 2026. https://bwnews.pr/2SynyAS
9. Wei XX. Dr Wei on the FDA approval of Pylarify TruVu for PSMA-PET imaging in prostate cancer. OncLive.com. March 31, 2026. Accessed March 31, 2026. https://www.onclive.com/view/dr-wei-on-the-fda-approval-of-pylarify-truvu-for-psma-pet-imaging-in-prostate-cancer
10. FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma. FDA. March 20, 2026. Accessed March 31, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma
11. Opdivo. Prescribing information. Bristol Myers Squibb; 2026. Accessed March 31, 2026. https://packageinserts.bms.com/pi/pi_opdivo.pdf
12. Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US and EMA approvals for Opdivo® (nivolumab). News release. Bristol Myers Squibb. March 20, 2026. Accessed March 31, 2026. https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Transforms-the-Classical-Hodgkin-Lymphoma-Treatment-Paradigm-with-Expanded-U-S--and-EMA-Approvals-for-Opdivo-nivolumab/default.aspx
13. Lunning M, Herrera A. Lunning and Herrera highlight frontline Hodgkin lymphoma management strategies. OncLive.com. March 18, 2024. Accessed March 31, 2026. https://www.onclive.com/view/lunning-and-herrera-highlight-frontline-hodgkin-lymphoma-management-strategies
14. Svoboda J. Dr Svoboda on the implications of nivolumab plus AVD in classical Hodgkin lymphoma. OncLive.com. June 19, 2023. Accessed March 31, 2026. https://www.onclive.com/view/dr-svoboda-on-the-implications-of-nivolumab-plus-avd-in-classical-hodgkin-lymphoma
15. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA. March 25, 2026. Accessed March 31, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
16. Lifyorli. Prescribing information. Corcept Therapeutics; March 2026. Accessed March 31, 2026. https://corcept.com/wp-content/uploads/Lifyorli_PI.pdf
17. FDA approves Corcept’s selective glucocorticoid receptor antagonist Lifyorli (relacorilant) plus nab-paclitaxel for treatment of patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Incorporated. March 25, 2026. Accessed March 31, 2026. https://ir.corcept.com/news-releases/news-release-details/fda-approves-corcepts-selective-glucocorticoid-receptor
18. Olawaiye A. Dr Olawaiye on updated OS data with relacorilant plus nab-paclitaxel in PROC. OncLive.com. February 3, 2026. Accessed March 31, 2026. https://www.onclive.com/view/dr-olawaiye-on-updated-os-data-with-relacorilant-plus-nab-paclitaxel-in-proc
19. Overall survival primary end point met in Corcept’s pivotal phase 3 ROSELLA trial of relacorilant in patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Incorporated. January 22, 2026. Accessed March 31, 2026. https://ir.corcept.com/news-releases/news-release-details/overall-survival-primary-endpoint-met-corcepts-pivotal-phase-3
20. Corcept submits marketing authorization application to European Medicines Agency for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics. October 14, 2025. Accessed March 31, 2026. https://ir.corcept.com/news-releases/news-release-details/corcept-submits-marketing-authorization-application-european
21. Chan A. Relacorilant plus nab-paclitaxel may serve as new standard of care in platinum-resistant ovarian cancer: Q&A with Domenica Lorusso, MD, PhD. OncLive.com. August 12, 2025. Accessed March 31, 2026. https://www.onclive.com/view/relacorilant-plus-nab-paclitaxel-may-serve-as-new-standard-of-care-in-platinum-resistant-ovarian-cancer
22. Lorusso D. Dr Lorusso on the rationale for investigating relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer. OncLive.com. September 18, 2025. Accessed March 31, 2026. https://www.onclive.com/view/dr-lorusso-on-the-rationale-for-investigating-relacorilant-plus-nab-paclitaxel-in-platinum-resistant-ovarian-cancer
23. Berman T, Konecny GE. Relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer: the ROSELLA trial. OncLive.com. July 17, 2025. Accessed March 31, 2026. https://www.onclive.com/view/relacorilant-plus-nab-paclitaxel-in-platinum-resistant-ovarian-cancer-the-rosella-trial
24. United States Securities and Exchange Commission. Form 8-K. Incyte Corporation. Published February 27, 2026. Accessed March 31, 2026. https://investor.incyte.com/static-files/3e4188ba-4c55-491d-a795-18136bfac9e8
25. Lantheus receives FDA tentative approval for Lutetium Lu 177 Dotatate (PNT2003), radioequivalent to Lutathera. News release. Lantheus Holdings, Inc. March 2, 2026. Accessed March 31, 2026. https://investor.lantheus.com/news-releases/news-release-details/lantheus-receives-fda-tentative-approval-lutetium-lu-177
26. Ipsen voluntarily withdraws Tazverik (tazemetostat) in follicular lymphoma and epithelioid sarcoma. March 9, 2026. Accessed March 31, 2026. https://www.ipsen.com/press-release/ipsen-voluntarily-withdraws-tazverik-tazemetostat-in-follicular-lymphoma-and-epithelioid-sarcoma-3251503/
27. Myriad Genetics receives FDA approval of the MyChoice CDx Test as the companion diagnostic for Zejula (niraparib) for patients with ovarian cancer. News release. Myriad Genetics, Inc. March 17, 2026. Accessed March 31, 2026. https://investor.myriad.com/news-releases/news-release-detail/27106/
28. Teva gains biosimilar momentum with U.S. FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab). News release. Teva. March 30, 2026. Accessed March 31, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Gains-Biosimilar-Momentum-with-U-S--FDA-Approval-of-PONLIMSI-denosumab-adet-and-Dual-Filing-Acceptance-for-Biosimilar-Candidate-to-Xolair-omalizumab/default.aspx