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

June 2026 delivered a steady run of FDA actions across breast, prostate, and kidney cancer, continuing a year that has already reshaped frontline treatment in several tumor types. The month's headline news came in its final week, when two long-awaited approvals in triple-negative and HER2-positive breast cancer landed within a day of each other. Earlier in the month, the agency cleared new combination regimens in prostate and kidney cancer, while several other applications, carried over from earlier reviews, saw their fates decided or further delayed in the final days of June.

Here is a roundup of the most notable FDA oncology news from June 2026.

Capivasertib Plus Abiraterone in PTEN-Deficient Prostate Cancer

Approved June 12

The FDA approved capivasertib (Truqap) in combination with abiraterone (Zytiga) and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer, the indication previously known as metastatic hormone-sensitive prostate cancer. The agency concurrently approved a companion diagnostic, the VENTANA PTEN (SP218) RxDx Assay, to identify eligible patients, who make up roughly one in four people with this diagnosis and tend to have more aggressive disease and a worse prognosis.

The approval was supported by the phase 3 CAPItello-281 trial (NCT04493853), in which the combination significantly improved radiographic progression-free survival (PFS), extending the median to 33.2 months compared with 25.7 months for abiraterone and prednisone alone. It is the first targeted therapy approved specifically for this PTEN-deficient population.

Belzutifan Plus Pembrolizumab as Adjuvant Therapy in Renal Cell Carcinoma

Approved June 12

The same day, the FDA approved belzutifan (Welireg) in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the adjuvant treatment of adults with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. The decision, based on the phase 3 LITESPARK-022 trial (NCT05239728), extends belzutifan's reach beyond its earlier approvals in pheochromocytoma/paraganglioma and von Hippel-Lindau disease-associated tumors into a much larger postsurgical population.

Sacituzumab Govitecan, Alone or With Pembrolizumab, in First-Line Triple-Negative Breast Cancer

Approved June 24

In one of the month's biggest stories, the FDA approved sacituzumab govitecan-hziy (Trodelvy) for 2 first-line indications in triple-negative breast cancer (TNBC): as a single agent for patients who are not candidates for PD-1/PD-L1 inhibitor therapy, and in combination with pembrolizumab for patients whose tumors express PD-L1 (CPS ≥10). The approvals give clinicians a frontline option across PD-L1 status for a disease that had gone roughly two decades without a major shift away from chemotherapy in the first-line setting.

The monotherapy indication was supported by the phase 3 ASCENT-03 trial (NCT05382299), which showed a median PFS of 9.7 months for sacituzumab govitecan vs 6.9 months for physician's choice chemotherapy. The combination indication drew on ASCENT-04/KEYNOTE-D19 (NCT05382286), in which adding sacituzumab govitecan to pembrolizumab extended median PFS to 11.2 months vs 7.8 months for chemotherapy plus pembrolizumab, a 35% reduction in the risk of progression or death.

Palbociclib as Maintenance Therapy in HR-Positive, HER2-Positive Metastatic Breast Cancer

Approved June 24

Also on June 24, the FDA approved palbociclib (Ibrance) in combination with trastuzumab (Herceptin), with or without pertuzumab (Perjeta), and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment. The approval extends palbociclib, long used in HR-positive, HER2-negative disease, into a biologically distinct population where both hormone receptor and HER2 signaling can drive resistance to single-pathway therapy.

The decision rests on the phase 3 PATINA trial (NCT02947685), which enrolled 518 patients with no evidence of progression after induction therapy and found that adding palbociclib to maintenance treatment reduced the risk of disease progression by 24%, extending median progression-free survival to 44.3 months compared with 29.1 months.

RP1 (Vusolimogene Oderparepvec) Resubmission Accepted, With a New Goal Date

Accepted for review June 26

After 2 prior complete response letters (CRLs), Replimune's BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma cleared a key hurdle on June 26, when the FDA accepted the company's latest resubmission as a complete, class 1 response. The agency set a goal date of August 2 and indicated it will convene an advisory committee meeting in late July, setting up one of the more closely watched oncology decisions of the summer.

Complete Response Letter for Ga 68 Edotreotide (LNTH-2501) in NET Imaging

CRL issued June 26

The same week, Lantheus disclosed that the FDA issued a CRL for LNTH-2501 (Ga 68 edotreotide), a PET diagnostic imaging kit for somatostatin receptor-positive neuroendocrine tumors. The agency said it could not approve the application by its June 29 target action date because of unresolved manufacturing-related conditions at a third-party facility, and explicitly noted the decision was unrelated to the product's safety or efficacy data. Lantheus is now working to resolve the outstanding facility issue.

Orca-T Gains FDA Approval in Matched Donor Transplants

Approved June 30

On the last day of the month, 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.

Looking ahead. June's approvals in breast, prostate, and kidney cancer continue a pattern seen throughout 2026: incremental but clinically meaningful expansions of already-established drug classes (ADCs, CDK4/6 inhibitors, AKT and HIF-2α inhibitors) into new biomarker-defined populations, rather than entirely new mechanisms of action. Several of the regulatory threads left open at the end of June, including RP1's advisory committee meeting and Lantheus's manufacturing resolution, will carry directly into the third quarter, alongside fresh decisions expected for gedatolisib, zanidatamab, and zidesamtinib.