May 2026 Brief

The FDA has approved the first PROTAC in any indication, supported by phase 3 VERITAC-2 data.

The second-generation T-cell immunotherapy Orca-Q demonstrated encouraging outcomes in an ongoing phase 1 trial.

The FDA has authorized expanded access to the RAS inhibitor daraxonrasib for patients with previously treated metastatic pancreatic ductal adenocarcinoma.

Jakafi XR offers bioequivalent alternative to twice-daily formulation; pharmacy availability expected by May 8.

A first-in-class allogeneic regulatory T-cell therapy advances into multicenter phase 1b/2a trial; trial start expected second half of 2026.

First-in-class double-loaded patient-derived immunotherapy joins pancreatic cancer and glioblastoma in FDA Fast Track portfolio; phase 1/2 trial now recruiting.

The FDA previously granted RZ-001 both orphan drug designation and fast track designation for hepatocellular carcinoma.

FDA fast tracks RPTR-1.201, a TCR bispecific immunotherapy for advanced triple-negative breast cancer, as RaPTR-101 tests safety and early efficacy.

The DLL3-targeting antibody-drug conjugate zocilurtatug pelitecan has elicited antitumor activity across subtypes of extrapulmonary neuroendocrine carcinomas.

Emiltatug ledadotin is a B7-H4–directed antibody-drug conjugate that has shown antitumor activity in adenoid cystic carcinoma and other solid tumors.

FDA approves an all-oral treatment for newly diagnosed acute myeloid leukemia, enhancing options for patients ineligible for intensive chemotherapy.

Sonrotoclax gains FDA approval as a promising treatment for relapsed mantle cell lymphoma, showcasing strong efficacy and safety in clinical trials.

The FDA has granted suplexa, a non-engineered autologous cellular immunotherapy, fast track designation for patients with MSI-H colorectal cancer.

The FDA approved atezolizumab for the adjuvant treatment of muscle invasive bladder cancer with ctDNA molecular residual disease after cystectomy.

The neoadjuvant and adjuvant FDA indications for T-DXd in HER2+ breast cancer are based on the DESTINY-Breast11 and DESTINY-Breast05 trials, respectively.

FDA fast-tracks sevabertinib for first-line HER2-mutant metastatic NSCLC, spotlighting strong SOHO-01 responses and manageable safety.

FDA grants orphan status to CLN‑049, an FLT3xCD3 T‑cell engager in phase 1, for relapsed/refractory patients with AML.

The sBLA for nogapendekin alfa inbakicept is supported by 36-month follow-up data from cohort B of the QUILT-3.032 trial.

The approval of the TROP2-directed ADC datopotamab deruxtecan is supported by results from the phase 3 TROPION-Breast02 trial.

The FDA awarded rare pediatric disease and orphan drug designation to the novel small molecule FL118 for osteosarcoma.

FDA clears HARMONIC trial changes as LP-300 targets EGFR L858R lung cancer after TKI failure, aiming for longer dosing and lower toxicity.

FDA extends camizestrant review as ctDNA-guided ESR1 switch sparks debate; new analyses debut at ASCO while Europe advances approval.

FDA grants priority review to neladalkib for post-TKI ALK+ NSCLC, aiming to beat resistance and brain metastases; decision due Nov 27, 2026.

Treatment with the ADC pivekimab sunirine can be initiated in an outpatient setting.

FDA fast tracks STX-0712, a CCR2-targeted CyTAC, as phase 1 trial enrolls to tackle relapsed/refractory CMML and monocytic AML.

The phase 3 POTOMAC study was the supporting trial for the FDA approval of the durvalumab combination for BCG-naive NMIBC.

The FDA granted the NDA for treatment of gastrointestinal stromal tumors with a PDUFA targeted action date of November 30, 2026.

FDA grants orphan drug status to EO2463 vaccine for watch-and-wait indolent NHL, advancing a potential treatment option and spotlighting promising SIDNEY trial data.