Upcoming 2026 FDA Decisions Could Expand Treatment Options Across Oncology and Hepatitis B

The beginning of 2026 was filled with numerous FDA approvals, New Drug Application (NDA) acceptances, and late-stage developments across oncology, infectious diseases, and cardiology, and we’re only halfway through the year. There are dozens more scheduled throughout the year, addressing gaps and unmet needs.

Here are a few key NDA acceptances with Prescription Drug User Fee Act dates scheduled for the second half of this year.

Gedatolisib (Celcuity, Inc.)—July 17

Celcuity, Inc. announced its NDA for gedatolisib, a PI3K/mTOR inhibitor, to treat hormone receptor–positive (HR+), HER2-negative, and PIK3CA wild-type advanced breast cancer.¹

The study submitted findings from the PIK3CA wild-type cohort of the phase 3 VIKTORIA-1 clinical trial evaluating the safety and efficacy of gedatolisib and fulvestrant with or without palbociclib compared with fulvestrant monotherapy.

According to the phase 3 trial results, the median progression-free survival (PFS) was 9.3 months for the triplet, 7.4 months for the doublet, and 2.0 months for fulvestrant monotherapy.²

Gedatolisib is unique as a PI3K/mTOR inhibitor, as it targets all 4 Class I PI3K isoforms and mTORC1 and mTORC2 for a comprehensive block of PAM pathways, unlike the currently available single-target PI3K inhibitors, which may be less effective in patients with PIK3CA wild-type disease.¹

Addressing this patient population is extremely important, as patients with PIK3CA wild-type advanced breast cancer make up more than 60% of second-line HR+ breast cancer cases, which is about 37,000 patients per year in the US.³

Gedatolisib has the potential to serve these patients who often have fewer effective targeted treatment options and may ultimately require chemotherapy.

Isatuximab (Sanofi)—July 23

On July 23, the FDA will decide on whether isatuximab-irfc can be delivered subcutaneously. The drug, manufactured by Sanofi, is already approved across several intravenous indications, including, since September 2024, for patients with newly diagnosed multiple myeloma who aren’t eligible for an autologous stem cell transplant.⁴

Sanofi submitted the supplemental biologics license application, which would amend the current approval to include subcutaneous administration.

Should the FDA approve it, isatuximab-irfc would be the first available cancer medicine to be administered through both an on-body injector and a manual injector.

This therapy has the potential to reduce patient treatment burden, improve quality of life, and reduce infusion-related reactions while maintaining the same level of efficacy.

Iberdomide (Bristol Myers Squibb)—August 17

Bristol Myers Squibb’s NDA was accepted with a PDUFA date scheduled for August 17 for iberdomide to treat patients with refractory or relapsed multiple myeloma (RRMM) as part of a combination therapy.⁵

The data submitted for the NDA was that of the phase 3 EXCALIBER-RRMM clinical trial evaluating the safety and efficacy of iberdomide in combination with current standard treatments, daratumumab, and dexamethasone. The clinical trial compared minimal residual disease (MRD) negativity and PFS of the triplet therapy with another combination therapy including daratumumab, bortezomib, and dexamethasone.

The FDA accepted the application based on MRD negativity results from the phase 3 EXCALIBER-RRMM trial, which is evaluating iberdomide for RRMM. Filing on MRD negativity rather than PFS is what makes this application notable. The trial is ongoing, with patients still being followed for PFS.

Iberdomide, should it become approved, would be the first of an investigational class of therapies called cereblon E3 ligase modulators (CELMoD) agents to be FDA-approved. CELMoD agents bind cereblon and promote degradation of transcription factors that allow myeloma cells to grow.

As a next-gen CELMoD, iberdomide has the potential to address a gap for patients who’ve stopped responding to immunomodulatory therapies in earlier lines. And as an oral agent, when combined with subcutaneous daratumumab and oral dexamethasone, treatment may be less burdensome for patients.

Zidesamtinib (Nuvalent, Inc.)—September 18

Zidesamtinib—manufactured by Nuvalent, Inc., which is being acquired by GSK—is an investigational ROS1 inhibitor designed to treat patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) who have received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI).⁶

The data submitted alongside the accepted NDA were from the global registrational phases 1 and 2 ARROS-1 clinical trials.

The ARROS-1 trial evaluated zidesamtinib in patients whose disease had progressed after at least one prior ROS1 TKI, including those with tumors that had developed resistance mutations. Early results demonstrated durable responses in both systemic disease and brain metastases, an especially important finding since the brain is a common site of progression for patients with ROS1-positive NSCLC.

Zidesamtinib is specifically designed to overcome the resistance mutations that can develop after earlier-generation ROS1 inhibitors while also improving penetration into the central nervous system. This dual approach could help address one of the biggest challenges in treating ROS1-positive disease—keeping cancer under control after patients exhaust their initial targeted therapy options.

If approved, zidesamtinib would offer a new precision medicine option for patients with advanced ROS1-positive NSCLC whose disease has progressed on prior TKIs, potentially extending the benefits of targeted therapy before patients need to transition to more generalized treatments like chemotherapy.

Bepirovirsen (GSK & Ionis Pharmaceuticals)—October 26

The FDA accepted GSK and Ionis Pharmaceuticals’ NDA for priority review for bepirovirsen, an investigational antisense oligonucleotide to treat patients with chronic hepatitis B.⁷

Hepatitis B currently affects over 1 million people in the US and requires lifelong suppressive antiviral therapy with low rates of functional cure. The FDA granted bepirovirsen breakthrough therapy designation—used to expedite the review of treatments for severe or life-threatening diseases—based on the phase 3 B-Well data. The agency had already granted the drug fast-track designation in February 2024.

The NDA is supported by findings from the phase 3 B-Well1 and B-Well2 clinical trials, which evaluated bepirovirsen in patients with chronic hepatitis B receiving or not receiving nucleos(t)ide analogue therapy. The studies demonstrated that a significantly greater proportion of patients treated with bepirovirsen achieved sustained hepatitis B surface antigen (HBsAg) clearance compared with placebo—a key marker of a functional cure, which equates to sustained HBsAg loss.

Bepirovirsen, rather than simply suppressing viral replication, targets the viral messenger RNA responsible for producing hepatitis B proteins. By reducing these viral proteins, the therapy aims to restore the body's immune response against the virus.

If approved, bepirovirsen would become the first antisense oligonucleotide approved for chronic hepatitis B and could represent an important step toward achieving finite treatment and a functional cure for patients living with the disease.

Anitocabtagene Autoleucel (Arcellx)—December 23

The final PDUFA date to watch this year falls on December 23rd for anitocabtagene autoleucel (Anito-cel), an investigational BCMA-directed CAR T-cell therapy developed by Arcellx—acquired by Gilead Sciences—for patients with relapsed or refractory multiple myeloma.⁸

The biologics license application is supported by results from the phase 1 and pivotal phase 2 iMMagine-1 clinical trials, which evaluated anito-cel in heavily pretreated patients with RRMM. Across the studies, the therapy demonstrated deep and durable responses alongside a predictable and manageable safety profile.

Anito-cel uses unique proprietary D-domain technology, which was designed to improve the specificity and binding of the CAR T cells while potentially reducing some of the toxicities associated with current CAR T-cell therapies.

Multiple myeloma remains an incurable disease, and many patients eventually relapse after multiple lines of treatment with diminishing responses and fewer available options. If approved, anito-cel could provide another important CAR T-cell therapy for patients with relapsed or refractory disease and may ultimately expand into earlier lines of treatment as additional studies continue.



References
1. Celcuity announces FDA acceptance of new drug application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. GlobalNewswire. January 20, 2026. Accessed July 7, 2026. https://www.globenewswire.com/news-release/2026/01/20/3221601/0/en/Celcuity-Announces-FDA-Acceptance-of-New-Drug-Application-for-Gedatolisib-in-HR-HER2-PIK3CA-Wild-Type-Advanced-Breast-Cancer.html
2. 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. 2026;44(12):1108-1119. doi:10.1200/JCO-25-02643
3. Gedatolisib (CELC) — PDUFA July 17, 2026. Dan Sfrea. Accessed July 7, 2026. https://dansfera.com/drug/gedatolisib-celc-breast-cancer-pdufa
4. FDA approves isatuximab-IRFC with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. FDA. September 20, 2024. Accessed July 7, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-bortezomib-lenalidomide-and-dexamethasone-newly-diagnosed-multiple
5. U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s new drug application for iberdomide in patients with relapsed or refractory multiple myeloma. News release. Bristol Myers Squibb. February 17, 2026. Accessed July 7, 2026. https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Iberdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx
6. Nuvalent announces FDA acceptance of New Drug Application for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1-POSITIVE NSCLC. PR Newswire. September 19, 2025. Accessed July 7, 2026. https://www.prnewswire.com/news-releases/nuvalent-announces-fda-acceptance-of-new-drug-application-for-zidesamtinib-for-the-treatment-of-tki-pre-treated-patients-with-advanced-ros1-positive-nsclc-302620883.html
7. Ionis’ partner GSK announces bepirovirsen accepted for priority review and granted breakthrough therapy designation by the US FDA as a potential first-in-class medicine for chronic hepatitis B. Businesswire. April 28, 2026. Accessed July 7, 2026. https://www.businesswire.com/news/home/20260427721143/en/Ionis-partner-GSK-announces-bepirovirsen-accepted-for-Priority-Review-and-granted-Breakthrough-Therapy-Designation-by-U.S.-FDA-as-a-potential-first-in-class-medicine-for-chronic-hepatitis-B
8. Gilead’s Anito-cel faces December PDUFA decision. allsci. May 9, 2026. Accessed July 7, 2026. https://allsci.com/news/earnings-call-insights/gileads-q126-earnings-call-anito-cel-poised-for-december-pdufa-decision-three-acquisitions-near-inflection-points/