Enhertu Expands into Early Breast Cancer with Dual FDA Approvals
On May 15, 2026, the US Food and Drug Administration (FDA) approved AstraZeneca and Daiichi Sankyo’s Enhertu® (fam‑trastuzumab deruxtecan‑nxki) intravenous (IV) infusion for the treatment of adults who have human epidermal growth factor receptor 2 (HER2) ‑positive early breast cancer in both neoadjuvant (pre‑surgical) and adjuvant (post‑surgical) settings. The first indication is for use prior to surgery in adult patients with stage II–III disease as part of a regimen with a taxane, trastuzumab and pertuzumab (THP), as determined by an FDA-authorized test. The second indication is for adjuvant treatment in patients with residual invasive disease following neoadjuvant HER2-targeted therapy (trastuzumab, with or without pertuzumab, and a taxane-based regimen). Enhertu is a HER2‑directed antibody‑drug conjugate (ADC) that delivers a cytotoxic topoisomerase I inhibitor payload directly to HER2‑expressing cancer cells. Approval was supported by results from the phase III DESTINY‑Breast11 and DESTINY‑Breast05 trials, which demonstrated statistically significant and clinically meaningful improvements in outcomes. Enhertu achieved higher pathologic complete response rates in the neoadjuvant setting (67.3% vs. 56.3% with standard chemotherapy regimen) and reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine in the adjuvant setting. The DESTINY‑Breast05 results also supported the addition of Enhertu in the NCCN Clinical Practice Guidelines® in Oncology as a Category 1 recommended treatment. The recommended dose is 5.4mg/kg administered every three weeks, with treatment duration varying by clinical setting. Safety considerations include a boxed warning for interstitial lung disease and pneumonitis, as well as warnings for neutropenia and left ventricular dysfunction. Here is the updated prescribing information.
FDA Approves Expanded Dosing Strategy for Crysvita in Adult XLH
The FDA approved Kyowa Kirin’s Crysvita® (burosumab‑twza) injection for an updated dosing regimen in adults with X‑linked hypophosphatemia (XLH) on May 14, 2026. Crysvita is a monoclonal antibody that blocks the activity of fibroblast growth factor 23 (FGF23) that restores more normal phosphate reabsorption and increases blood levels of vitamin D for patients aged six months and older who have XLH, a rare, progressive genetic disorder characterized by phosphate wasting. This approval expands existing indications by introducing a flexible dose-escalation strategy for adult patients who do not achieve or maintain normal serum phosphorus levels following initial therapy. Updated prescribing information allows escalation from the standard every‑four‑week dosing to 0.5mg/kg (max 90mg) every two weeks, with the option to further increase to 1mg/kg (max 90mg) every two weeks after four weeks if needed, based on serum phosphorus response. Approval was based on post‑approval clinical experience and prior clinical data. The updated prescribing information is here.
Tecentriq Gains New Indication for ctDNA-Directed Adjuvant Use Post-Cystectomy
On May 15, 2026, the FDA approved Genentech’s Tecentriq® (atezolizumab) IV infusion and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) subcutaneous (SC) formulation for the adjuvant treatment of adults who have muscle-invasive bladder cancer (MIBC) and have circulating tumor DNA (ctDNA) molecular residual disease following cystectomy, as identified by an FDA-authorized test. Patients undergoing cystectomy for MIBC often enter a period of post-surgical monitoring with uncertainty regarding recurrence risk. This approval represents a first-in-class, ctDNA-guided treatment approach, leveraging the Signatera™ CDx assay to identify patients with molecular residual disease who are at higher risk of relapse and could benefit from early initiation of immunotherapy, while enabling others without detectable disease to avoid additional treatment and associated toxicities. Tecentriq is a programmed death-ligand 1 (PD-L1) blocking antibody for the treatment of various cancers. Approval was based on significantly improved outcomes versus placebo, reducing the risk of disease recurrence or death by 36% and the risk of death by 41%. The recommended dose for Tecentriq is 840mg every two weeks, 1,200mg every three weeks, or 1,680mg every four weeks for up to one year or until disease recurrence or unacceptable toxicity. The SC formulation, Hybreza, is given at 1,875mg/30,000 units every three weeks for up to one year. ctDNA monitoring should continue in patients with negative Signatera CDx results until positivity or completion of the 12‑month testing period. Here is the prescribing information for Tecentriq and Tecentriq Hybreza.
Datroway Indication Expanded into Triple Negative Breast Cancer
The FDA granted a new indication to Daiichi Sankyo and AstraZeneca’s Datroway® (datopotamab deruxtecan-dlnk) for the treatment of adult patients who have unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for programmed death-1 (PD-1)/PD-L1 inhibitor therapy on May 22, 2026. Metastatic TNBC is an aggressive disease with a poor prognosis and limited targeted treatment options, as the absence of key receptors restricts therapy primarily to chemotherapy for many patients. Initially approved in January of 2025 for hormone receptor (HR) positive, HER2-negative breast cancer, Datroway is a specifically engineered TROP-2 directed antibody and topoisomerase inhibitor conjugate enabling targeted delivery of a topoisomerase I inhibitor to tumor cells. Approval was based on the phase III TROPION-Breast02 trial, which demonstrated statistically significant and clinically meaningful improvements in overall survival of 23.7 months versus 18.7 months with chemotherapy and progression-free survival of 10.8 months versus 5.6 months, along with higher objective response rates at 64% compared with 30% for chemotherapy. The recommended dose is 6mg/kg administered IV every three weeks until disease progression or unacceptable toxicity, with key safety considerations including interstitial lung disease/pneumonitis, ocular adverse reactions and stomatitis. Full prescribing information is available here.