Q2 2026 in Oncology: A Look Back at FDA Approvals and Decisions

The second quarter of 2026 turned out to be one of the busier stretches of the year for FDA oncology activity, bookended by 2 notable advisory committee votes and a steady cadence of approvals in breast, prostate, and kidney cancer. The quarter also delivered its share of setbacks, most notably a second rejection for Replimune's oncolytic immunotherapy RP1, underscoring that not every closely watched application crossed the finish line. By the time June closed out, several of the threads left open during the quarter, including RP1's third attempt and a manufacturing-related delay for a neuroendocrine tumor imaging agent, were already rolling into Q3.

Here is a roundup of the most notable FDA oncology news from Q2 2026 (April through June).

Brexucabtagene Autoleucel Converts to Full Approval in Mantle Cell Lymphoma

Approved April 2

The quarter opened with the FDA converting the accelerated approval of brexucabtagene autoleucel (brexu-cel; Tecartus) to traditional approval for adults with relapsed or refractory mantle cell lymphoma. The conversion was supported by long-term follow-up data from the phase 2 ZUMA-2 trial (NCT02601313) confirming durable efficacy and a consistent safety profile, closing out a postmarketing commitment that had been open since the CAR T-cell therapy's initial accelerated approval.

A Second Complete Response Letter for RP1 in Advanced Melanoma

CRL issued April 10

Replimune's oncolytic immunotherapy RP1 (vusolimogene oderparepvec), in combination with nivolumab, suffered a second regulatory setback when the FDA issued a new complete response letter, again concluding that the phase 1/2 IGNYTE trial (NCT03767348) did not provide substantial evidence of effectiveness in patients with melanoma who had progressed on anti–PD-1 therapy. The company had resubmitted following a type A meeting in September 2025, believing it had addressed the agency's prior concerns, including new IGNYTE data showing a 34% objective response rate and a median duration of response of 24.8 months. Replimune's leadership called the decision "deeply disappointing," and the episode raised real questions about the program's path forward heading into the back half of the year.

FDA's First ODAC of 2026 Splits on Breast and Prostate Cancer Drugs

Meeting held April 30

In its first meeting in more than 9 months, the Oncologic Drugs Advisory Committee (ODAC) took up two AstraZeneca applications in a single day. In the morning session, the panel voted 6-3 against the clinical benefit of switching to camizestrant upon detection of an ESR1 mutation, ahead of radiographic progression, in HR-positive, HER2-negative advanced breast cancer, concluding that the phase 3 SERENA-6 trial (NCT04964934) wasn't designed to isolate the benefit of earlier treatment switching despite the drug's clear biological activity. In the afternoon, the committee reversed course, voting 7-1 (with 1 abstention) in favor of capivasertib (Truqap) plus abiraterone (Zytiga) and prednisone for PTEN-deficient metastatic hormone-sensitive prostate cancer, setting up the favorable approval that would follow in June.

Vepdegestrant Approved for ESR1-Mutated Breast Cancer

Approved May 1

The FDA approved vepdegestrant (Veppanu), an oral PROTAC estrogen receptor degrader, for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who progressed on at least one line of endocrine therapy. The agency simultaneously approved the Guardant360 CDx companion diagnostic to identify eligible patients, giving this difficult-to-treat, endocrine-resistant population a new oral targeted option.

Zenocutuzumab Approved for NRG1 Fusion-Positive Cholangiocarcinoma

Approved May 8

The FDA approved zenocutuzumab-zbco (Bizengri) for adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring an NRG1 gene fusion, an extremely rare and life-threatening molecular subset, extending the drug's reach beyond its earlier approval in NRG1 fusion-positive lung and pancreatic cancers.

Decitabine/Cedazuridine Plus Venetoclax Approved for Newly Diagnosed AML

Approved May 13

The FDA approved the oral combination of decitabine and cedazuridine (Inqovi) with venetoclax (Venclexta) for newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or those with comorbidities precluding intensive induction chemotherapy, offering an all-oral hypomethylating regimen for a population that often cannot tolerate more intensive treatment.

Sonrotoclax Receives Accelerated Approval in Mantle Cell Lymphoma

Approved May 13

The same day, the FDA granted accelerated approval to sonrotoclax (Beqalzi), a next-generation BCL2 inhibitor, for relapsed or refractory mantle cell lymphoma following at least two prior lines of therapy, including a BTK inhibitor. The approval, the first new BCL2 inhibitor in a decade according to its manufacturer, was based on a 52% objective response rate in the phase 1/2 BGB-11417-201 trial (NCT05471843).

T-DXd Approved for Two New Indications in Early HER2-Positive Breast Cancer

Approved May 15

The FDA approved fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for 2 indications in HER2-positive early-stage breast cancer: as neoadjuvant therapy followed by a taxane, trastuzumab (Herceptin), and pertuzumab (Perjeta; THP) for stage II or III disease, and as adjuvant therapy for patients with residual invasive disease after neoadjuvant treatment. The neoadjuvant approval was supported by the DESTINY-Breast11 trial (NCT07239271), which showed a pathologic complete response rate of 67.3% with T-DXd followed by THP vs 56.3% with standard chemotherapy-based treatment, marking T-DXd's first move into early-stage disease.

Dato-DXd Approved as First-Line Therapy in Triple-Negative Breast Cancer

Approved May 22

The FDA approved datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, based on the phase 3 TROPION-Breast02 trial (NCT05374512). The trial showed a median overall survival of 23.7 months with Dato-DXd vs 18.7 months with chemotherapy, a five-month improvement that the Triple Negative Breast Cancer Foundation called a long-overdue advance for a population that had relied on chemotherapy alone as first-line treatment.

Belzutifan Plus Pembrolizumab Approved as Adjuvant Therapy in Kidney Cancer

Approved June 12

The FDA approved belzutifan (Welireg) in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the adjuvant treatment of clear cell renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, based on the phase 3 LITESPARK-022 trial (NCT05239728).

Capivasertib Approved for PTEN-Deficient Prostate Cancer

Approved June 12

The same day, the FDA approved capivasertib in combination with abiraterone and prednisone for PTEN-deficient metastatic androgen pathway modulation-naive or -sensitive prostate cancer, following its favorable ODAC vote in April. The approval, supported by the phase 3 CAPItello-281 trial (NCT04493853) showing a median radiographic progression-free survival of 33.2 months vs 25.7 months for abiraterone alone, marks the first targeted therapy for this PTEN-deficient population, which makes up roughly a quarter of patients with this diagnosis.

Sacituzumab Govitecan and Palbociclib Approved in Breast Cancer

Approved June 24

The FDA approved sacituzumab govitecan-hziy (Trodelvy), alone or with pembrolizumab, for first-line treatment of triple-negative breast cancer across PD-L1 status, supported by the ASCENT-03 (NCT05382299) and ASCENT-04/KEYNOTE-D19 (NCT05382286) trials. The same day, the agency approved palbociclib (Ibrance) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance treatment for HR-positive, HER2-positive metastatic breast cancer following induction therapy, based on the phase 3 PATINA trial's 24% reduction in the risk of disease progression.

Orca-T Gains FDA Approval in Matched Donor Transplants

Approved June 30

On the last day of the quarter, the FDA approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Orca-T; Tregzi) for use in matched donor hematopoietic stem cell transplantation with a myeloablative preparative regimen for the treatment hematopoietic and immunologic reconstitution and to improve chronic graft-vs-host disease-free survival in the treatment of adults with hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes.

Carryover Decisions Into Q3: RP1's Third Attempt and a Manufacturing Delay for a NET Imaging Agent

Late June

The quarter closed with two regulatory threads handed off into Q3. On June 26, the FDA accepted Replimune's latest RP1 resubmission as a complete, class 1 response, setting a new goal date of August 2 and scheduling an advisory committee meeting for late July, the company's third attempt at approval after 2 prior rejections. The same week, Lantheus disclosed that the FDA could not approve its NET imaging agent Ga 68 edotreotide (LNTH-2501) by its June 29 target date, citing unresolved manufacturing conditions at a third-party facility unrelated to the product's safety or efficacy data.

Looking back at the quarter. Q2 2026 was defined less by novel mechanisms than by the steady expansion of established drug classes, ADCs, CDK4/6 and AKT inhibitors, and immune checkpoint combinations, into new biomarker-defined or earlier-line populations. The quarter's 2 ODAC votes also offered a useful reminder that advisory committees can still split sharply even on drugs from the same sponsor in the same week, and that a favorable trial readout doesn't guarantee a favorable review, as Replimune's second CRL for RP1 made clear.