Q3 2026 Oncology Outlook: Key FDA Decisions to Watch

The third quarter of 2026 brings a fresh slate of high-stakes FDA decisions across breast cancer, melanoma, gastric cancer, hematologic malignancies, and lung cancer. Several of these actions represent carryover reviews that slipped from earlier in the year due to manufacturing questions or complete response letters, while others are entering review for the first time. Collectively, they underscore the oncology pipeline's continued emphasis on targeted therapies, antibody-drug conjugates, and cell-based immunotherapies for patients who have exhausted standard options.

Here is a look at the most anticipated FDA decisions expected in Q3 2026.

Orca-T in Hematologic Malignancies

Expected July 6

Orca-T, an investigational allogeneic T-cell immunotherapy, is under review for the treatment of hematologic malignancies including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndromes (MDS). The biologics license application (BLA) was originally assigned an action date of April 6, but the FDA classified an April submission of updated chemistry, manufacturing, and controls (CMC) information as a major amendment, extending the review by 3 months to July 6.

The phase 3 Precision-T study (NCT04013685), which supports the application, met its primary end point of survival free of chronic graft-vs-host disease (cGVHD): 78% of patients in the Orca-T arm achieved this outcome compared with 38% in the conventional allogeneic stem cell transplant arm. Orca Bio, the sponsor, has said the FDA has not requested additional clinical data, and the company continues to prepare for a potential mid-2026 commercial launch pending approval.

T-DXd in Post-Neoadjuvant HER2-Positive Early Breast Cancer

Expected July 7

Having already secured approval in May for neoadjuvant and adjuvant use following the DESTINY-Breast11 (NCT07239271) and DESTINY-Breast05 (NCT04622319) data, trastuzumab deruxtecan (T-DXd; Enhertu) has a separate, related supplemental BLA under priority review for adult patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant HER2-targeted therapy. The FDA assigned a target action date of July 7.

This application is built on the phase 3 DESTINY-Breast05 trial, in which T-DXd significantly improved invasive disease-free survival compared with trastuzumab emtansine (T-DM1; Kadcyla) in patients with high-risk residual disease, including a meaningful reduction in distant recurrence and brain metastasis events.

Gedatolisib in HR+/HER2-, PIK3CA Wild-Type Advanced Breast Cancer

Expected July 17

Gedatolisib, a first-in-class, multitarget inhibitor of the PI3K/AKT/mTOR pathway, is under priority review for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer in patients who have progressed after a CDK4/6 inhibitor and an aromatase inhibitor^.3 The new drug application was submitted under the FDA's Real-Time Oncology Review program, and gedatolisib has already received both breakthrough therapy and fast track designations.

The application is supported by results from the PIK3CA wild-type cohort of the phase 3 VIKTORIA-1 trial (NCT05501886), published in the Journal of Clinical Oncology earlier this year.⁴ If approved, gedatolisib would offer a new option for a population that has historically had limited choices once disease progresses after standard endocrine-based therapy.

“This is something I would want to offer my patients. I think it also gives patients hope, because the data that we've had post CDK4/6 inhibitor for single-agent endocrine therapy, in some cases, is on the order of 2 to 3 months of progression-free survival. When we've gotten into the doublet therapies that target this pathway, around 5.5 months is what the expectation is,” said Sara Hurvitz, MD, medical oncologist, clinical research leader, and senior vice president of the Clinical Research Division at Fred Hutch Cancer Center, in an interview with Targeted Oncology.

RP1 (Vusolimogene Oderparepvec) in Advanced Melanoma

Expected August 2

RP1, an oncolytic immunotherapy from Replimune, is back under FDA review in combination with nivolumab (Opdivo) for advanced melanoma, following 2 prior complete response letters. After a Type A meeting in May, the company and the FDA aligned on a path forward, and Replimune resubmitted its BLA in late June. The agency accepted the resubmission as a complete, class 1 response, setting a goal date of August 2 and notifying the company to expect an advisory committee meeting in late July.⁵

The application is supported by the phase 1/2 IGNYTE trial (NCT03767348), which showed a blinded independent central review-assessed objective response rate of roughly 34% in patients who had progressed on prior anti-PD-1 therapy, with a median duration of response approaching 3 years. The upcoming advisory committee meeting will likely be the most closely watched oncology adcomm of the quarter, given the agency's earlier concerns about whether IGNYTE constituted adequate and well-controlled evidence of effectiveness.⁶

Zanidatamab in First-Line HER2-Positive Gastroesophageal Adenocarcinoma

Expected August 25

Zanidatamab (Ziihera), a bispecific HER2-directed antibody already approved for biliary tract cancer, is under priority review for a supplemental BLA seeking approval in first-line HER2-positive, unresectable, locally advanced, or metastatic gastroesophageal adenocarcinoma (GEA) in combination with chemotherapy. The application is supported by the HERIZON-GEA-01 trial (NCT05152147), and zanidatamab has also received breakthrough therapy designation for use alongside fluoropyrimidine- and platinum-based chemotherapy with or without tislelizumab in this setting.⁷

A second interim overall survival analysis from HERIZON-GEA-01 is expected around the middle of this year, which could further bolster the case for the combination as a new first-line standard in a disease where treatment options remain limited.

Zidesamtinib in ROS1-Positive Non–Small Cell Lung Cancer

Expected September 18

Zidesamtinib, an investigational ROS1 tyrosine kinase inhibitor (TKI) from Nuvalent, is under review for adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) who have received at least one prior ROS1 TKI. The application is based on results from the global registrational ARROS-1 trial, and zidesamtinib has received both breakthrough therapy and orphan drug designations.⁸

Pending a positive outcome, Nuvalent has indicated it anticipates a US commercial launch later this year, with a label-expansion submission for TKI-naive ROS1-positive NSCLC also planned for the second half of 2026.

REFERENCES

1. Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic Malignancies. News release. Orca Bio. April 1, 2026. Accessed June 29, 2026. https://tinyurl.com/5n98xv5u

2. ENHERTU® Granted Priority Review in the U.S. as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer. News release. Daiichi-Sankyo. March 9, 2026. Accessed June 29, 2026. https://tinyurl.com/5fpz94a9

3. Celcuity announces FDA acceptance of new drug application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. News release. Celcuity Inc. January 20, 2026. Accessed June 29, 2026. https://tinyurl.com/mxzywcxd

4. Hurvitz SA, Layman RM, Curigliano G, et al. VIKTORIA-1 trial of gedatolisib plus fulvestrant with or without palbociclib in hormone receptor–positive/HER2−/PIK3CA wild-type advanced breast cancer. J Clin Oncol. Published online March 9, 2026. doi:10.1200/JCO-25-02643

5. Complete response letter. FDA. April 10, 2026. Accessed June 29, 2026. https://tinyurl.com/4nrh4fdj

6. Replimune announces FDA acceptance of RP1 biologics license application resubmission for advanced melanoma. News release. Replimune Group, Inc. June 26, 2026. Accessed June 29, 2026. https://tinyurl.com/4d54t3x7

7. Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental biologics license application for Ziihera (zanidatamab-hrii) combinations in first-line HER2+ locally advanced or metastatic GEA. News release. Jazz Pharmaceuticals. April 27, 2026. Accessed June 29, 2026. https://tinyurl.com/4cmy69ku

8. Nuvalent announces FDA acceptance of new drug application for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1-positive NSCLC. News release. Nuvalent. November 19, 2025. Accessed June 29, 2026. https://tinyurl.com/yre6w4tr