Specialties & Diseases > Oncology & Hematology

Summer 2026 FDA oncology roundup: Tumor-agnostic RET, perioperative bladder, and a subcutaneous myeloma switch

By Alpana Mohta, MD, DNB, FEADV, FIADVL, IFAADFact-checked by Davi ShermanPublished August 11, 2026

Key Takeaways

RET fusion testing now has broader stakes: Selpercatinib’s tumor-agnostic traditional approval reinforces broad genomic profiling with fusion detection, especially when standard options are exhausted.
EV + pembrolizumab may reset perioperative MIBC care: In cisplatin-eligible patients, it improved EFS, OS, and pCR vs gemcitabine/cisplatin, shifting regimen choice toward toxicity and comorbidity profiles.
SC isatuximab can streamline myeloma care: Comparable efficacy with ~13-minute administration may reduce infusion-chair time and treatment burden.

Cancer treatment is shifting from tumor type to molecular biology.

Nearly half of the FDA’s accelerated oncology approvals between 2011 and 2023 were for cancer therapeutic products, 48% of which were for a biomarker-defined population.^[] July’s FDA decisions well indicate this evolution.

Selpercatinib receives traditional approval for RET-fusion tumors

On July 14, the FDA granted traditional approval to selpercatinib for adults and children aged 2 years and older with locally advanced or metastatic RET fusion-positive solid tumors.^[] Eligible patients must have progressed on or following prior systemic therapy or have no satisfactory alternative treatment options.

The decision converts selpercatinib’s previous accelerated approvals (granted for adults in 2022 and pediatric patients 2 years of age and older in 2024) to traditional approval following confirmatory evidence of clinical benefit.^[]

Supporting evidence included LIBRETTO-001, which enrolled 75 patients with RET fusion-positive non-small cell lung cancer and thyroid cancer.

The objective response rate was 47%. Median response duration reached 24.5 months.
Responses appeared across colorectal, pancreatic, salivary, breast, ovarian, small intestine, soft tissue, and salivary tumors, among others.

Pediatric evidence comes from LIBRETTO-121, an international, single-arm, multicohort trial that included 25 patients ages 2 to 20 with advanced or metastatic RET-activated solid tumors that were not responsive to available therapies or with no available standard systemic curative therapy.^[] The confirmed overall response rate was 48%, with 92% of responders remaining in response at 12 months.

However, the FDA’s approval notice explicitly says the indication is for patients with solid tumors with a RET gene fusion “as detected by an FDA-approved test.”^[]

RET fusions are most commonly identified in non-small cell lung and thyroid cancers, but they also occur at much lower frequencies across other solid tumors. Genomic profiling can identify potentially actionable RET alterations in other cancers.^[]^[]

Daniel Landau, MD, a board-certified medical oncologist, internist, and hematologist, says, “Selpercatinib targets a specific abnormality called a RET fusion. These fusions are rare, but they can occur in many different types of cancer. If you don’t test for them, you won’t find them.”

“Broad genomic testing that can detect gene fusions should be the norm,” he adds.

Enfortumab vedotin plus pembrolizumab for bladder cancer

The July 10 approval of pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph with enfortumab vedotin-ejfv applies to all patients with muscle-invasive bladder cancer who are candidates for cystectomy.^[] The regimen had previously been approved only for patients who were ineligible for cisplatin-based chemotherapy.

KEYNOTE-B15/EV-304 enrolled 808 patients with previously untreated, cisplatin-eligible muscle-invasive bladder cancer. Participants received perioperative pembrolizumab and enfortumab vedotin-ejfv or neoadjuvant gemcitabine and cisplatin before cystectomy.

Median event-free survival was not reached with the antibody-drug conjugate and checkpoint inhibitor combination, compared with 48.5 months after chemotherapy.
The hazard ratio was 0.53. Overall survival also favored the combination, with an HR of 0.65.
Pathologic complete response reached 55.8%, vs 32.5% with chemotherapy.^[]

“EV plus pembrolizumab was tested directly against gemcitabine and cisplatin in patients who were healthy enough to receive cisplatin, and EV plus pembrolizumab did better,” Dr. Landau says. He views the regimen as a potential “new standard treatment option” for muscle-invasive bladder cancer.

“Previously, there was a fairly simple way of thinking about this. If a patient could tolerate cisplatin, we generally gave cisplatin-based chemotherapy before surgery. If they couldn’t, we looked for alternatives, but this trial changes that,” he adds.

Discussing the toxicity profile, Dr. Landau warns, “With EV, I worry about nerve damage, skin reactions, and high blood sugar. Pembrolizumab can cause the immune system to attack normal organs, which occasionally can be serious or even permanent.” Adverse events requiring close surveillance include rash, hyperglycemia, neuropathy, ocular effects, and pneumonitis. Pembrolizumab can also trigger immune-mediated toxicity.^[]

“For decades, chemotherapy with cisplatin has been a major part of how we treat these patients before surgery. Now we have a completely different approach that actually performed better than cisplatin-based chemotherapy in a large clinical trial,” Dr. Landau says.

Cisplatin has its own limitations, Dr. Landau adds, including kidney injury, hearing loss, neuropathy, and myelosuppression. As he notes, treatment selection may therefore increasingly depend on individual patient factors rather than cisplatin eligibility alone.

“Cisplatin has plenty of problems of its own. It can damage the kidneys, affect hearing, cause nerve problems, and lower blood counts. But oncologists also have decades of experience using it. … A patient who already has significant nerve problems or poorly controlled diabetes might not be the best candidate for EV. Someone with kidney problems or significant hearing loss might be a poor candidate for cisplatin. This gives us an opportunity to choose treatment based on the individual patient rather than trying to make every patient fit the same treatment,” he adds.

Subcutaneous Isatuximab for multiple myeloma

On July 9, the FDA approved subcutaneous (SC) isatuximab-irfc, sold as Sarclisa Escena, for the existing multiple myeloma indications of intravenous (IV) isatuximab.^[] Administration uses the CirCLIQ on-body delivery system or a syringe with an infusion set.

In the IRAKLIA noninferiority trial involving 531 patients:

SC isatuximab plus pomalidomide and dexamethasone produced a 71.1% response rate, compared with 70.5% for the IV formulation.
The subcutaneous formulation also met its pharmacokinetic co-primary endpoint.
Compared to IV infusion, median on-body administration time for SC administration was approximately 13 minutes.^[]
IV isatuximab infusions last several hours during early cycles.

According to Dr. Landau, “Patients with multiple myeloma spend a lot of time getting treatment. Isatuximab has traditionally been given through an IV, which means more time sitting in an infusion chair. The new formulation can be given as an injection under the skin and appears to work just as well.”

“Saving time with every treatment can make a meaningful difference for patients. It also frees up infusion chairs and nursing time. It’s not the kind of approval that completely changes how we treat myeloma, but it can make life easier for both patients and cancer centers. That’s valuable, too,” he adds.

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