The approval was based on results from the phase 3 VERITAC-2 trial (NCT05654623), a randomized, open-label, active-controlled, multicenter study of 624 patients, including 270 with ESR1-mutated tumors.
May 1: Vepdegestrant (Veppanu)
On May 1, the FDA approved vepdegestrant (Veppanu; Arvinas Operations, Inc), a heterobifunctional protein degrader, for adults with estrogen receptor–positive, human epidermal growth factor receptor 2–negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test. Vepdegestrant is indicated for patients with disease progression following at least 1 line of endocrine therapy. The FDA also approved the Guardant360 CDx as a companion diagnostic to identify patients with ESR1 mutations eligible for treatment.
May 8: Zenocutuzumab-Zbco (Bizengri)
On May 8, the FDA approved zenocutuzumab-zbco (Bizengri) for adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. Zenocutuzumab-zbco is the first drug approved for this population.
The approval was based on efficacy findings from a single-arm trial that enrolled 19 patients with NRG1 fusion-positive cholangiocarcinoma. In the trial, 36.8% of patients had an overall response. The duration of response ranged from 2.8 months to 12.9 months. The FDA granted zenocutuzumab-zbco Breakthrough Therapy and Orphan Drug designations.
May 13: Decitabine and Cedazuridine (Inqovi)
On May 13, the FDA approved oral decitabine and cedazuridine (Inqovi; Taiho Oncology, Inc) tablets in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or in adults with comorbidities that preclude the use of intensive induction chemotherapy. The FDA granted orphan drug designation to decitabine and cedazuridine for this indication.
The approval was based on Study ASTX727-07, a single-arm, open-label clinical trial evaluating decitabine and cedazuridine tablets in combination with venetoclax in adults with newly diagnosed AML aged 75 years or older or with comorbidities that precluded intensive induction chemotherapy (N = 101).
May 13: Sonrotoclax (Beqalzi)
On May 13, the FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least 2 lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.
The approval was supported by BGB-11417-201 (NCT05471843), a single-arm, multicenter trial that evaluated efficacy in 103 adults with relapsed or refractory mantle cell lymphoma. Patients had previously received anti-CD20-based therapy and a BTK inhibitor.
May 15: T-DXd (Enhertu)
On May 15, the FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki; T-DXd; Daiichi Sankyo, Inc) for 2 separate indications in adults with HER2-positive early-stage breast cancer. T-DXd, followed by taxane, trastuzumab, and pertuzumab, is approved for neoadjuvant treatment of adults with HER2-positive (IHC 3+ or ISH+) stage II or III breast cancer, as determined by an FDA-authorized test. T-DXd is also approved for adjuvant treatment of adults with HER2-positive breast cancer who have residual invasive disease after neoadjuvant treatment with trastuzumab, with or without pertuzumab, and taxane-based treatment.
The neoadjuvant approval was based on DESTINY-Breast11, a randomized, 3-arm, open-label, multicenter trial of 927 adults with HER2-positive, high-risk, early-stage breast cancer. The adjuvant approval was based on DESTINY-Breast05, a randomized, 2-arm, open-label, multicenter trial of 1,635 adults with residual invasive disease after neoadjuvant therapy.
May 18: Baxdrostat (Baxfendy)
On May 18, 2026, the FDA approved Baxdrostat (Baxfendy) for the treatment of hypertension, in combination with other antihypertensive medications, to lower blood pressure in adults whose hypertension is not adequately controlled.
The approval was based on results from the phase 3 BaxHTN trial, which included patients with uncontrolled and resistant hypertension receiving standard of care.
May 22: Datopotamab Deruxtecan-dlnk (Datroway)
On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk (Datroway; Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
The approval was based on results from TROPION-Breast02, a multicenter, open-label, randomized trial of 644 patients with unresectable or metastatic TNBC.