April Roundup of FDA Approvals in Oncology: 2 Decisions to Know

Below is your guide to all the oncologic options that were approved, rejected, or withdrawn by the FDA in April 2026.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.

4/2: Brexucabtagene Autoleucel in Mantle Cell Lymphoma

Indication: The FDA converted the approval of brexucabtagene autoleucel (Tecartus; brexu-cel) from accelerated to traditional status for adult patients with relapsed/refractory mantle cell lymphoma (MCL).^1,2

Supporting Data: The conversion was based on the totality of evidence from the phase 2 ZUMA-2 trial (NCT02601313). In cohort 3 (n = 86), which enrolled BTK inhibitor–naive patients who had received up to 5 prior lines of therapy, the objective response rate (ORR) was 91%, the complete remission (CR) rate was 79%, and the median duration of response (DOR) was not reached (NR) at a median follow-up of 23.0 months. In cohort 1 (n = 60), which enrolled more heavily pretreated patients who received a median of 3 prior lines, the ORR was 87% and the CR rate was 62%; the median DOR was NR at a median follow-up of 8.6 months. In pooled safety data across all cohorts, cytokine release syndrome occurred in 93% of patients (grade ≥ 3, 12%), and neurologic events occurred in 80% (grade ≥ 3, 33%).

Clinical Significance: The full approval of brexu-cel, now supported by data in earlier-line and BTK inhibitor–naive patients, reinforces its role as a CAR T-cell option capable of delivering deep and durable remissions in relapsed/refractory MCL. The cohort 3 data expand the evidence base to patients who have not yet exhausted BTK inhibitor therapy, a population that represents a growing share of the relapsed/refractory MCL landscape.

“If you put [patients from] cohort 1, cohort 2, and cohort 3 all together…the ORR is still very high and CR [rate] was very high,” Luhua (Michael) Wang, MD, of The University of Texas MD Anderson Cancer Center, said in an exclusive interview with OncLive®.³

OTHER RELATED COVERAGE

• In another interview, Lore Gruenbaum, PhD, Blood Cancer United, unpacked the importance of the approval⁴ and spotlighted areas of research she believes should be explored beyond CAR T-cell therapies like brexu-cel in the MCL field.⁵
• In a recent Peer Exchange,⁶ “Unpacking Key Data from ASH 2024,” a panel of experts featuring Andre H. Goy, MD, Jamie Koprivinikar, MD, and Harsh Parmar, MD, reviewed 5-year follow-up findings from ZUMA-2,⁷ which revealed long-term efficacy with brexu-cel in patients with MCL.
• In a recent interview, Tom van Meerten, MD, PhD, of the University Medical Center Groningen, Netherlands, walked through the design and patient population of cohort 3 of ZUMA-2, detailed the efficacy and manageable safety profile of brexu-cel in BTK inhibitor–naive patients, and discussed the agent’s use in clinical practice for select subgroups.⁸

4/10: CRL to RP1 Plus Nivolumab in Advanced Melanoma

Regulatory Action: The FDA issued a second complete response letter (CRL) to the biologics license application seeking approval of vusolimogene oderparepvec (RP1) in combination with nivolumab (Opdivo) for adult patients with advanced melanoma who have progressed on an anti–PD-1–containing regimen.⁹ This follows an initial CRL issued in July 2025.¹⁰

Basis for the CRL: The FDA cited deficiencies in both the single-arm phase 1/2 IGNYTE trial (NCT03767348) and the phase 3 IGNYTE-3 trial (NCT06264180). For IGNYTE, the agency flagged that the inability to isolate RP1’s individual contribution to efficacy, population heterogeneity, and response assessment confounds including surgical interventions. For IGNYTE-3, concerns centered on the limited number of patients treated to date (10% of the planned population), investigator-only response assessment, absence of DOR data, and inadequate statistical controls for the submitted progression-free survival analysis. Key efficacy findings from IGNYTE revealed an ORR of 32.9% (95% CI, 25.2%-41.3%) and a median DOR of 33.7 months (95% CI, 14.1-NR) in patients with confirmed progression on prior anti–PD-1 therapy, with a manageable toxicity profile.

Clinical Significance: The second CRL for this combination represents a significant regulatory setback for RP1 in a setting of high unmet need: patients with anti–PD-1–refractory advanced melanoma. “The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews,” Sushil Patel, PhD, of Replimune, the drug developer, stated in a news release.¹¹ “Additionally, we had also aligned on the design of the confirmatory study. We strongly believe that RP1 in combination with nivolumab can bring substantial benefit to advanced melanoma patients.”

OTHER RELATED COVERAGE

• On September 2, 2025, it was announced that the FDA scheduled a Type A meeting with Replimune to discuss the CRL.¹¹ On September 18, 2025, the company had completed the Type A meeting and shared that it was reviewing the feedback provided by the regulatory agency; it was noted that a path toward accelerated approval was not yet determined.¹²
• Data from IGNYTE shared during the 2025 ASCO Annual Meeting showed that RP1 produced responses in deep/visceral lesions and across injected/non-injected lesions in patients with advanced PD-1–refractory melanoma.¹³
• In a recent News Network program, Michael A. Postow, MD, and Chenyang Zhan, MD, PhD, broke down data from the IGNYTE trial examining RP1 paired with nivolumab in advanced melanoma following PD-1 inhibition.¹⁴
• Initial efficacy and safety data from the IGNYTE study were also covered by Michael B. Atkins, MD, in a past Rapid Readout program.¹⁵

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References

1. US FDA grants full approval of Kite’s Tecartus for adult patients with relapsed or refractory mantle cell lymphoma. News release. Gilead Sciences, Inc. April 2, 2026. Accessed May 4, 2026. https://www.gilead.com/company/company-statements/2026/us-fda-grants-full-approval-of-kite-tecartus-for-adult-patients-with-relapsed-or-refractory-mantle-cell-lymphoma
2. Tecartus. Prescribing Information. Kite Pharma, Inc; April 2026. Accessed May 4, 2026. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/tecartus/tecartus-pi.pdf
3. Wang LM. Dr Wang on the full FDA approval of brexu-cel in R/R mantle cell lymphoma. OncLive.com. April 14, 2026. Accessed May 4, 2026. https://www.onclive.com/view/dr-wang-on-the-full-fda-approval-of-brexu-cel-in-r-r-mantle-cell-lymphoma
4. Gruenbaum L. Dr Gruenbaum on the significance of the FDA approval of brexu-cel for MCL. OncLive.com. April 8, 2026. Accessed May 4, 2026. https://www.onclive.com/view/dr-gruenbaum-on-the-significance-of-the-fda-approval-of-brexu-cel-for-mcl
5. Kandel R. Moving the needle in MCL: FDA approvals, personalized therapies, and emerging agents: Q&A with Lore Gruenbaum, PhD. OncLive.com. April 9, 2026. Accessed May 4, 2026. https://www.onclive.com/view/moving-the-needle-in-mcl-fda-approvals-personalized-therapies-and-novel-agents-coming-down-the-pike
6. Goy AH, Kprivnikar J, Parmar H. Overview of ZUMA-2 cohorts 1-3: Use of brexu-cel in R/R MCL. OncLive.com. May 15, 2025. Accessed May 4, 2026. https://www.onclive.com/view/overview-of-zuma-2-cohorts-1-3-use-of-brexu-cel-in-r-r-mcl
7. Ryan C. Long-term data support continued use of brexu-cel in R/R mantle cell lymphoma: Q&A with Michael Wang, MD. OncLive.com. December 18, 2024. Accessed May 4, 2026. https://www.onclive.com/view/long-term-data-support-continued-use-of-brexu-cel-in-r-r-mantle-cell-lymphoma
8. Flaherty C. ZUMA-2 data support earlier-line role for brexu-cel in high-risk R/R MCL subgroups: Q&A with Tom van Meerten, MD, PhD. OncLive.com. January 6, 2025. Accessed May 4, 2026. https://www.onclive.com/view/zuma-2-data-support-earlier-line-role-for-brexu-cel-in-high-risk-r-r-mcl-subgroups
9. Complete response letter for BLA 125827. FDA. Accessed May 4, 2026. https://download.open.fda.gov/crl/CRL_BLA125827_20260410.pdf
10. Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma. News release. Replimune. July 22, 2025. Accessed May 4, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-receives-complete-response-letter-fda-rp1-biologics
11. Replimune announces Type A meeting scheduled with FDA. News release. Replimune Group, Inc. September 2, 2025. Accessed May 4, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-announces-type-meeting-scheduled-fda
12. Replimune provides update following Type A meeting with FDA. News release. Replimune. September 18, 2025. Accessed May 4, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-provides-update-following-type-meeting-fda
13. In GK, Wong MKK, Sacco JJ, et al. Response analysis for injected and non-injected lesions and of the safety and efficacy of superficial and deep/visceral RP1 injection in the registrational cohort of anti–PD-1–failed melanoma patients of the IGNYTE trial. J Clin Oncol. 2025;43(suppl 16):9537. doi: 10.1200/JCO.2025.43.16_suppl.9537
14. Postow MA, Zhan C. Data for RP1 plus nivolumab in metastatic melanoma after prior PD-1 inhibition. OncLive.com. May 14, 2025. Accessed May 4, 2026. https://www.onclive.com/view/data-for-rp1-plus-nivolumab-in-metastatic-melanoma-after-prior-pd-1-inhibition
15. Atkins MB. Initial efficacy and safety of RP1 + nivolumab in patients with anti–PD-1–failed melanoma from the ongoing phase 1/2 IGNYTE study. OncLive.com. June 26, 2023. Accessed May 4, 2026. https://www.onclive.com/view/initial-efficacy-and-safety-of-rp1-nivolumab-in-patients-with-anti-pd-1-failed-melanoma-from-the-ongoing-phase-1-2-ignyte-study