Oncology FDA Approval– category –

On June 2, 2026, the U.S. Food and Drug Administration (FDA) approved Cavhanza (Cycle Pharmaceuticals), an orally disintegrating tablet (ODT) formulation of the second-generation BCR-ABL1 tyrosine kinase inhibitor nilotinib, for adults w...

On May 28, 2026, the FDA approved durvalumab (Imfinzi, AstraZeneca) plus BCG (Bacillus Calmette-Guerin) intravesical therapy for adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). In the POTOMAC trial (n=1,018): DFS HR 0.68 (95% CI 0.50-0.93, p=0.0154). This is the first immunotherapy combination regimen approved for NMIBC.

On May 27, 2026, the FDA approved pivekimab sunirine-pvzy (Decnupaz), AbbVie's CD123-directed ADC, for adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare hematologic malignancy. In the CADENZA trial: CR + CRc 69.7% in treatment-naive BPDCN (n=33), 15.7% in R/R BPDCN (n=51). This is the first new BPDCN approval in 8 years since tagraxofusp-erzs.

On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk (Datroway), a TROP2-directed ADC from Daiichi Sankyo/AstraZeneca, for first-line adults with unresectable or metastatic triple-negative breast cancer ineligible for PD-1/PD-L1 inhibitor therapy. In TROPION-Breast02: median PFS 10.8 vs 5.6 mo (HR 0.57, p

On May 15, 2026, the FDA approved atezolizumab (Tecentriq, Genentech/Roche) for adjuvant treatment of muscle-invasive bladder cancer in patients with molecular residual disease (MRD), marking a landmark biomarker-guided approval in urothelial carcinoma.

On May 13, 2025, the FDA approved zenocutuzumab-zbco (Bizengri, Merus N.V.) for advanced or metastatic cholangiocarcinoma harboring NRG1 fusions, introducing a first-in-class NRG1-blocking bispecific antibody to clinical practice.

On May 15, 2026, the FDA approved Enhertu (T-DXd, Daiichi Sankyo/AstraZeneca) for two new indications in HER2+ early breast cancer (neoadjuvant + adjuvant for residual disease). pCR ~65-70%, iDFS HR 0.55. A reshaping of the early breast cancer paradigm.

On May 13, 2026, the FDA approved oral Inqovi (decitabine + cedazuridine, Taiho Oncology) plus venetoclax for newly diagnosed AML in adults ≥75y or unfit for IC. The first fully-oral, non-intensive AML regimen.

On May 13, 2026, the FDA granted accelerated approval to Beqalzi (sonrotoclax, BeOne) for R/R MCL post-BTKi. ORR ~70%, CR ~50%. The first BCL-2i monotherapy approval in MCL.

On May 1, 2026, the FDA approved VEPPANU (vepdegestrant) for ESR1-mutated ER+/HER2- advanced breast cancer. The first-ever PROTAC approval. VERITAC-2: PFS HR 0.57.

On April 2, 2026, the FDA granted traditional approval to Tecartus (brexu-cel, Kite/Gilead) for relapsed/refractory mantle cell lymphoma. ZUMA-2 Cohort 3 (BTKi-naïve): ORR 91%, CR 79%.

On March 20, 2026, the U.S. FDA approved nivolumab (Opdivo) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adults and pediatric patients aged 12 years and older with previously untreated, Stage III or IV classica...

On March 5, 2026, the U.S. FDA approved teclistamab (Tecvayli), a BCMA×CD3 bispecific antibody, in combination with daratumumab hyaluronidase-fihj for adults with relapsed or refractory multiple myeloma (RRMM) who have received at least ...

FDA approval summary On February 26, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor zongertinib (Hernexeos, Boehringer Ingelheim) for an expanded indication in adult patients with u...

FDA approval summary On February 24, 2026, the U.S. Food and Drug Administration (FDA) granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorourac...

FDA approval summary On February 11, 2026, the U.S. Food and Drug Administration (FDA) approved a low electric field generator device, Optune Pax (Novocure), in combination with gemcitabine and nab-paclitaxel for the treatment of adult p...

FDA approval summary On February 10, 2026, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with...

FDA approval summary On January 27, 2026, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (V...

FDA approval summary On December 17, 2025, the U.S. Food and Drug Administration (FDA) granted regular approval to rucaparib (Rubraca, pharmaand GmbH) for adult patients with metastatic castration-resistant prostate cancer (mCRPC) associ...

FDA approval summary On December 15, 2025, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with un...