FDA red and green lights: April 2026

April saw just one FDA oncology approval, a full nod for Gilead’s Tecartus in relapsed/refractory mantle cell lymphoma. There was also a second CRL for Replimune’s oncolytic virus vusolimogene oderparepvec, with the company and the agency clashing again over the Ignyte trial.However, May is already off to a good start, with Arvinas and Pfizer getting an early green light for their oral oestrogen degrader vepdegestrant, now branded Veppanu. The question now is who will sell the drug, with the companies looking for another partner.Car-T confirmationTecartus, a CD19-targeting Car-T, received accelerated approval in July 2020 for relapsed/refractory mantle cell lymphoma, a rare type of non-Hodgkin’s lymphoma. That nod was based on the single-arm Zuma-2 trial, further results from which also supported the full go-ahead.The label now includes data from cohort 3 of the study, which enrolled second-line patients naive to BTK inhibitors. Here, Gilead claimed an overall response rate of 91%; however, this encompasses only 86 efficacy evaluable patients. Including all 95 leukapheresed patients gives an ORR of 82%.Tecartus is also FDA approved for relapsed/refractory B-cell acute lymphoblastic leukaemia. However, sales are dwarfed by those of Gilead’s other CD19 Car-T, Yescarta, with the products bringing in $344m and $1.5bn respectively in 2025. Revenues from both are decreasing, with Gilead blaming competition.Second knockbackMeanwhile, things look grim for Replimune, which had hoped its own uncontrolled Ignyte trial would be enough to get vuso-vec approved for post-PD-(L)1 melanoma.Instead, the FDA said that the study didn’t provide substantial evidence of the project’s effectiveness, adding that it had first raised concerns in 2021. The agency took the unusual step of publishing the CRL in real time, giving investors a chance to compare and contrast it and the company’s response. Replimune, for its part, contended that the agency had been inconsistent in its communications.The latest knockback follows a CRL in July 2025, also over Ignyte, and raises questions about whether Replimune will be able to continue. The company is carrying out a confirmatory trial, Ignyte-3, but only has cash into the first quarter of 2027, and has said that development of vuso-vec “will not be viable” without timely accelerated approval.Third degraderOn the first day of May, Arvinas and Pfizer’s Veppanu became the third oral oestrogen degrader, and the first so-called Protac, to get the FDA thumbs up. A decision had been expected by 5 June.However, like Menarini’s Orserdu and Lilly’s Inluriyo, Veppanu is only approved for second-line ER-positive, HER2-negative breast cancer patients with ESR1 mutations.And it might be a while before the new drug hits the market. Arvinas and Pfizer disclosed last year that they were looking for a third party for commercialisation, after dropping plans in first-line disease. No deal has yet emerged, although on Friday the companies said they were “on track” to announce the selection of a new partner.A fourth contender, Roche's giredestrant, is awaiting an FDA decision by 18 December, but again only in ESR1 mutants. Approval might come sooner in the adjuvant setting, where Roche just disclosed a filing using a priority review voucher. However, the first-line Persevera trial recently failed. Selected April 2026 US regulatory decisions in oncologyPDUFA dateOutcomeDrugCompanyIndicationNoteUndisclosedFull approval 2 Apr 2026TecartusGilead2nd-line-plus mantle cell lymphoma (BTKi naive)Confirmed accelerated approval in r/r MCL Jul 202410 Apr 2026CRL 10 Apr 2026Vusolimogene oderparepvecReplimunePD-(L)1 inhibitor refractory melanomaSecond CRL; Ignyte trial “insufficient” for approvalSource: OncologyPipeline.