August Roundup of FDA Approvals in Oncology: Daraxonrasib Highlights 5 Decisions to Know

Below is your guide to all the oncologic options that were given the green light by the FDA in August 2026. The regulatory roundup provides everything you need to know, right at your fingertips, with all the topline data that supported the decisions and expert insights detailing clinical practice implications.

8/6: RP1 Plus Nivolumab in Anti–PD-1–Pretreated Advanced Melanoma

Indication: The FDA granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev; RP1) in combination with nivolumab (Opdivo) for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a PD-1–blocking antibody–based regimen.¹

Supporting Data: The decision was supported by findings from the phase 1/2 IGNYTE trial (NCT03767348), which enrolled patients with advanced melanoma whose disease had progressed following a prior anti–PD-1–containing regimen.² Data from the efficacy-evaluable population (n = 91) that supported the approval showed the combination elicited an objective response rate (ORR) of 24.2% (95% CI, 15.8%-34.3%), with a median duration of response of 14.1 months (95% CI, 10.7-not reached).¹

Clinical Significance: The approval provides a new option for patients with advanced melanoma whose disease has progressed on anti–PD-1 therapy, a setting with limited effective treatments. The regimen pairs RP1, an oncolytic immunotherapy delivered intratumorally, with nivolumab, and reached the market following a lengthy regulatory path that included 2 complete response letters and a July 2026 advisory committee vote in favor of the IGNYTE data. As an accelerated approval, continued clearance may be contingent on verification of clinical benefit in a confirmatory trial.¹

“With the approval of RP1 plus nivolumab, it now will fit into the post–PD-1 immunotherapy-refractory space. The only other FDA-approved therapy in that space presently is the use of tumor-infiltrating lymphocyte [TIL] therapies,” Michael K. Wong, MD, PhD, FRCPC, former physician in chief and professor of oncology at Roswell Park Comprehensive Cancer Center in Buffalo, New York, told OncLive^®. “No matter how you look at it, it’s a little harder to get patients into TIL therapies, given the need for lesion harvesting, manufacturing, lymphodepleting chemotherapy, infusion, and IL-2 support. As RP1 plus nivolumab takes its place in the treatment landscape, it has more of a universal appeal in this patient population.”

8/13: Iberdomide Plus Daratumumab and Dexamethasone in Relapsed/Refractory Multiple Myeloma

Indication: The FDA granted accelerated approval to iberdomide (Zenbexus) plus daratumumab and hyaluronidase-fihj (Darzalex Faspro) and dexamethasone (IberDd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent.^3,4

Supporting Data: The decision was based on findings from the phase 3 EXCALIBER-RRMM trial (NCT04975997), which evaluated IberDd vs daratumumab plus bortezomib (Velcade) and dexamethasone (DVd).⁵ Patients treated with IberDd (n = 207) achieved a minimal residual disease–negative complete response rate at any time of 41% (95% CI, 34%-48%) vs 21% (95% CI, 15%-27%) with DVd (P < .0001).³

Clinical Significance: The regimen is the first CELMoD-based combination to earn FDA approval, extending an all-oral immunomodulatory backbone to patients as early as first relapse. The accelerated approval was based on minimal residual disease–negativity data, with the trial continuing to evaluate progression-free survival (PFS).⁴

“IberDd is a BCMA-sparing regimen. You can save BCMA [targeting] for later down the line, or maybe use [IberDd] after BCMA,” Rahul Banerjee, MD, FACP, an associate professor in the Clinical Research Division at Fred Hutchinson Cancer Center and an associate professor in the Division of Hematology and Oncology at the University of Washington School of Medicine in Seattle, said. “Importantly, it works so much better in my mind than DVd. Comparing them both mechanistically and [by] the study results, IberDd is the way to go.”

8/25: Zanidatamab-Based Regimens in First-Line HER2-Positive Gastroesophageal Adenocarcinoma

Indication: The FDA approved zanidatamab-hrii (Ziihera) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra) as first-line treatment for adult patients with HER2-positive (immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH] positive), unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma, as detected by an FDA-approved test; and zanidatamab in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for adult patients with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma, as detected by an FDA-approved test.⁶

Supporting Data: The approvals were based on findings from the phase 3 HERIZON-GEA-01 trial (NCT05152147), which showed that in the intention-to-treat population, the median PFS was 12.4 months (95% CI, 9.8-18.5) with zanidatamab plus tislelizumab and chemotherapy (n = 302) vs 8.1 months (95% CI, 7.0-8.9) with trastuzumab (Herceptin) plus chemotherapy (n = 308; HR, 0.63; 95% CI, 0.51-0.78; P < .0001). The median overall survival was 26.4 months (95% CI, 21.5-30.3) vs 19.2 months (95% CI, 16.8-21.8), respectively (HR, 0.72; 95% CI, 0.57-0.90; P = .0043).⁷

Clinical Significance: The decision establishes a HER2-directed bispecific antibody, with or without a checkpoint inhibitor, as a first-line standard for HER2-positive gastroesophageal adenocarcinoma, and pairs the regimens with companion diagnostics to guide patient selection.⁶

“[This approval] will present some options, and options are good, usually. Options will…need to be tailored according to individual patients, because we have 2 treatment options for patients with newly diagnosed metastatic HER2-positive gastric cancer, not to mention the [ongoing] phase 3 trials in that space that could [further] change the landscape,” Zev A. Wainberg, MD, a professor of medicine at UCLA and co-director of the UCLA Gastrointestinal Oncology Program, said.

8/26: Daraxonrasib in Previously Treated Metastatic Pancreatic Adenocarcinoma

Indication: The FDA approved daraxonrasib (Rasonque), an oral RAS(ON) multiselective inhibitor, for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy or are not candidates for multi-agent systemic therapy.⁸

Supporting Data: The approval was supported by findings from the phase 3 RASolute 302 trial (NCT06625320), which were presented at the 2026 ASCO Annual Meeting.⁹ In the RAS G12–mutated population, the median overall survival (OS) was 13.2 months (95% CI, 10.0-not estimable) with daraxonrasib vs 6.6 months (95% CI, 5.4-8.2) with investigator’s choice of chemotherapy (HR, 0.40; 95% CI, 0.30-0.54; P = 5.9×10⁻¹⁰); in the overall population, the median OS was 13.2 months vs 6.7 months (95% CI, 5.8-8.0), respectively (HR, 0.40; 95% CI, 0.30-0.53; P = 4.6×10⁻¹¹). The confirmed ORR by blinded independent central review was 33.2% vs 11.8% in the RAS G12–mutated population (P < .0001).⁸

Clinical Significance: The agent is the first-in-class targeted therapy approved for metastatic pancreatic cancer, delivering a substantial survival improvement in a malignancy that has historically offered few effective options beyond chemotherapy.⁸

“The patients who received daraxonrasib [during RASolute 302] lived twice as long as those who received chemotherapy,” Kim A. Reiss Binder, MD, the assistant program director of the Hematology/Oncology Fellowship Program and an associate professor of medicine (hematology-oncology) at the Hospital of the University of Pennsylvania, said. “That is something we’ve never seen before in a pancreatic cancer study.”

8/28: Rusfertide in Polycythemia Vera

Indication: The FDA approved rusfertide (Mimrylo) for the treatment of adult patients with polycythemia vera.¹⁰

Supporting Data: The approval was supported by findings from the phase 3 VERIFY trial (NCT05210790), which enrolled 293 patients with polycythemia vera who had uncontrolled hematocrit and were phlebotomy dependent despite standard-of-care therapy.¹² In the 32-week analysis of part 1a, 76.9% of patients treated with rusfertide (n = 147) achieved a clinical response, defined as absence of phlebotomy eligibility with no phlebotomies from weeks 20 to 32, compared with 32.9% of those given placebo (n = 146; P < .0001). Rusfertide also met key secondary end points, including a lower mean number of phlebotomies (0.5 vs 1.8; P < .0001) and a higher proportion of patients maintaining hematocrit below 45% (62.6% vs 14.4%; P < .0001).¹²

Clinical Significance: Rusfertide is a first-in-class injectable hepcidin mimetic that restricts iron availability for red blood cell production, offering a novel approach to controlling erythrocytosis in polycythemia vera and reducing reliance on therapeutic phlebotomy.¹¹

References

1. FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma. FDA. August 6, 2026. Accessed September 1, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma
2. Wong MK, Milhem MM, Sacco JJ, et al. RP1 combined with nivolumab in advanced anti–PD-1–failed melanoma (IGNYTE). J Clin Oncol. 2025;43(33):3589-3599. doi:10.1200/JCO-25-01346
3. FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma. FDA. August 13, 2026. Accessed September 1, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone
4. US FDA grants accelerated approval to Bristol Myers Squibb’s first CELMoD therapy Zenbexus, in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) for patients with multiple myeloma, as early as first relapse. News release. Bristol Myers Squibb. August 13, 2026. Accessed September 1, 2026. https://news.bms.com/news/corporate-financial/2026/U-S--FDA-Grants-Accelerated-Approval-to-Bristol-Myers-Squibbs-First-CELMoD-Therapy-ZENBEXUS-in-Combination-with-Daratumumab-and-Hyaluronidase-fihj-and-Dexamethasone-ZDd-for-Patients-with-Multiple-Myeloma-as-Early-as-First-Relapse/default.aspx
5. Lonial S, Dimopoulos MA, Berdeja JG, et al. EXCALIBER-RRMM: a phase III trial of iberdomide, daratumumab, and dexamethasone in relapsed/refractory multiple myeloma. Future Oncol. 2025;21(14):1761-1769. doi:10.1080/14796694.2025.2501920
6. FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma. FDA. August 25, 2026. Accessed September 1, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction
7. Shitara K, Elimova E, Liu T, et al; HERIZON-GEA-01 Investigators. Zanidatamab with and without tislelizumab in HER2-positive gastroesophageal cancer. N Engl J Med. 2026;394(20):2002-2014. doi:10.1056/NEJMoa2517729
8. FDA approves first-in-class targeted therapy for metastatic pancreatic cancer. FDA. August 26, 2026. Accessed September 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-class-targeted-therapy-metastatic-pancreatic-cancer
9. Wolpin BM, Wainberg ZA, Hendifar AE, et al. Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): primary and final analysis from the phase 3 RASolute 302 study. J Clin Oncol. 2026;44(suppl 17):LBA4005. doi:10.1200/JCO.2026.44.17_suppl.LBA4005.
10. FDA approves first drug of its kind for polycythemia vera, a rare blood disorder. FDA. August 28, 2026. Accessed September 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder
11. Takeda receives US FDA approval of Mimrylo (rusfertide), marking a potential shift in the treatment paradigm for polycythemia vera. News release. Takeda. August 28, 2026. Accessed September 1, 2026. https://www.takeda.com/en-us/newsroom/news-releases/2026/fda-approval-mimrylo/
12. Kuykendall AT, Pemmaraju N, Pettit KM, et al. Results from VERIFY, a phase 3, double-blind, placebo-controlled study of rusfertide for treatment of polycythemia vera (PV). J Clin Oncol. 2025;43(suppl 17):LBA3. doi:10.1200/JCO.2025.43.17_suppl.LBA3