DESTINY-Breast05 is a Phase 3 trial of adjuvant trastuzumab deruxtecan (T-DXd, Enhertu) versus T-DM1 in high-risk HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy. T-DXd reduced the risk of invasive recurrence or death by 53% (iDFS HR 0.47; p<0.0001), with 3-year iDFS 92.4% versus 83.7%, supporting FDA approval on May 15, 2026. Sponsor: AstraZeneca / Daiichi Sankyo.
HER2+ Early Breast Cancer · Residual DiseaseTrastuzumab Deruxtecan (Enhertu)SABCS 2025 · NEJM 2026 · NCT04622319✓ FDA APPROVED MAY 15 2026
Posts by physicians about DESTINY-Breast05, newest first: ESMO 2026 week (October 17–24, 2026), then earlier posts from the ESMO 2025 presentation, SABCS 2025 and January 2026. Each post is shown in full and verbatim and linked to the original on X.
Median iDFS was NOT REACHED in both arms at interim analysis. T-DXd reduced the risk of invasive disease recurrence or death by 53% — HR 0.47 (95% CI 0.34–0.66; P<0.0001). The 3-year iDFS rate was 92.4% (T-DXd) vs. 83.7% (T-DM1). Distant disease recurrence risk fell 51% and brain metastasis risk fell 36% with T-DXd.
✓ iDFS HR 0.47 — 53% reduction in invasive recurrence/death
OS data was immature at the interim analysis (2.9% data maturity). OS hazard ratio was 0.61 (95% CI 0.34–1.10), 3-year OS 97.4% (T-DXd) vs. 95.7% (T-DM1). Final OS analysis pending.
Regulatory status & clinical implications — FDA approved May 15, 2026 via Project Orbis; dosing 5.4 mg/kg IV Q3W x14 cycles; boxed warning ILD & embryo-fetal toxicity. (FDA.gov) ✅ FDA-approved: DESTINY-Breast 05 adds T-DXd (Enhertu) as a new adjuvant option for adult patients with HER2-positive (IHC 3+ or ISH+) early breast cancer with residual invasive disease following neoadjuvant trastuzumab (±pertuzumab) plus taxane therapy. T-DM1 (Kadcyla) retains its existing KATHERINE-based indication on label; T-DXd does not formally replace it, but did demonstrate head-to-head superiority on iDFS in DB-05 and is positioned by investigators as a potential new standard of care. ✅ Companion approval: Via DESTINY-Breast 11 (same May 15, 2026 FDA action under Project Orbis), T-DXd → THP is also approved in the neoadjuvant setting for Stage II/III HER2+ disease. Together the two indications extend T-DXd across the HER2+ curative-intent continuum. Investigators including Shanu Modi (MSK) describe T-DXd as a potential new standard of care in early-stage disease given its head-to-head superiority over T-DM1.
Sponsor / Drug — AstraZeneca / Daiichi Sankyo; T-DXd (Enhertu), a HER2-directed antibody-drug conjugate. (FDA label)
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated October 24, 2026.
Great discussion of DestinyBreast05 quality of life data!
Similar overall HRQoL, but better pain symptoms (are these relapses?) and worse social functioning with TDXd
Preserved QoL does not mean absence of toxicity
@OncoAlert #ESMO26 https://t.co/TqjnDWQy67
DESTINY-Breast05: PROs at #ESMO26
HRQoL was largely maintained with both T-DXd and T-DM1 in high-risk HER2+ early breast cancer with residual invasive disease.
@OncoAlert #BCSM #BreastCancer https://t.co/3rroj3ppmI
[Slide 1]
16:15 - 17:45 Rapid oral: Breast cancer, early stage
CHAIRS: MARIA VITTORIA DIECI, SANDRA XIMENA FRANCO MILLAN, LILIT HARUTYUNYAN
DESTINY-Breast05 Study Design and Interim Results
A global, multicenter, randomized, open-label phase 3 trial (NCT04622319)
Population
• Residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant chemotherapy with HER2-directed therapy (NAT)(a)
• High risk of recurrence(b)
• Centrally confirmed HER2+ (IHC 3+ and/or ISH+) eBC
• ECOG PS 0 or 1
N = 1635
R 1:1
T-DXd 5.4 mg/kg IV Q3W for 14 cycles N = 818
T-DM1 3.6 mg/kg IV Q3W for 14 cycles N = 817
40-day safety follow-up
Primary endpoint
• IDFS by INV
Key secondary endpoint
• DFS by INV
Other secondary endpoints
• OS, DRFI by INV, BMFI by INV, safety
Exploratory endpoints
• HRQoL/PRO
Interim Efficacy and Safety Results (DCO: July 02, 2025)(1,2,c)
Post-neoadjuvant T-DXd demonstrated superior efficacy with no new safety signals in patients with high-risk HER2+ eBC and residual invasive disease after NAT,(1,2) and is now FDA approved(3)
• IDFS events (T-DXd, 51 [6.2%] vs T-DM1, 102 [12.5%]) hazard ratio, 0.47 [95% CI, 0.34-0.66]; P <0.001)
• 53% reduction in the risk of invasive disease recurrence or death
• Estimated 3-year IDFS rates were 92.4% for T-DXd and 83.7% for T-DM1
The overall safety profile of T-DXd showed no new safety signals
• In both treatment arms, >72% of patients had completed 14 treatment cycles(c); treatment had concluded for all patients in the study at DCO
• Adjudicated drug-related ILD cases were mostly low grade and reversible with treatment management guidelines
We report exploratory PRO results at interim analysis (DCO: July 02, 2025)
BMFI, brain metastasis-free interval; CI, confidence interval; DCO, data cutoff; DFS, disease free-survival; DRFI, distant recurrence-free interval; eBC, early breast cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; HER2, human epidermal growth factor receptor 2; HRQoL, health-related quality of life; IDFS, invasive disease-free survival; IHC, immunohistochemistry; ILD, interstitial lung disease; INV, investigator; ISH, in situ hybridization; IV, intravenous; NAT, neoadjuvant therapy; OS, overall survival; PRO, patient-reported outcome; Q3W, every 3 weeks; R, randomization; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan.
(a)NAT is defined as ≥16 weeks NAT with ≥9 weeks of trastuzumab ± pertuzumab and ≥9 weeks of taxane-based chemotherapy. (b)High-risk defined as Inoperable (cT4, N0-3, M0 or cT1-3, N2-3, M0) before NAT or Operable (cT1-3, N0-1, M0) before NAT with axillary node-positive disease (ypN1-3) after NAT. (c)Median study treatment duration: T-DXd, 9.8 months; T-DM1, 9.7 months.
1. Loibl S et al. N Engl J Med. 2026;394(9):845-857. 2. Geyer CE Jr et al. Presented at: ESMO Annual Congress; October 17-21, 2025; Berlin, Germany. 3. FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer. Press release. May 15, 2026. Accessed July 10, 2026.
Dr. Carlos Barrios
[Slide 3]
Overall HRQoL Was Preserved From Baseline With Both T-DXd and T-DM1 (EORTC QLQ-C30(a))
[three line charts: Mean (SD) CFB by cycle C2, C6, C10, C14; Better/Worse; ± 10-point change is considered clinically meaningful]
GHS/QoL
Physical Functioning
Emotional Functioning
Patients with CFB data,(c) n | C2 | C6 | C10 | C14
T-DXd (n = 818) | 715 | 591 | 545 | 456
T-DM1 (n = 817) | 701 | 619 | 562 | 480
(same patient counts shown under each of the three panels)
Legend: T-DXd (solid) / T-DM1 (dashed)
Mean change from baseline remained stable (within ± 10 points) over time across GHS/QoL, physical functioning, and emotional functioning in both treatment groups, supporting preservation of HRQoL during treatment
C, cycle; CFB, change from baseline; EORTC QLQ-BR23, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 23; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EQ-5D-5L, EuroQol 5-Dimension 5-Level questionnaire; GHS, global health status; PRO, patient-reported outcome; QoL, quality of life; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; VAS, visual analog scale.
(a)Higher scores in the EORTC QLQ-C30 GHS/QoL and functioning scales correspond to a higher/healthier level of functioning or QoL. (b)Day 1 of each cycle. (c)PRO data collected after new anti-cancer therapy, completion of 14 treatment cycles, or discontinuation of study drug are excluded.
Dr. Carlos Barrios
📌 Rapid Oral Breast Cancer, Early stage
✨Patient-reported outcomes from DESTINY-Breast05: HRQoL with T-DXd versus T-DM1 in patients with high-risk HER2-positive eBC
#ESMO26 🇪🇸 @OncoAlert #OncoAlertAF https://t.co/8YCn03ukj9
[Slide 1]
16:15 - 17:45 Rapid oral: Breast cancer, early stage
CHAIRS: MARIA VITTORIA DIECI, SANDRA XIMENA FRANCO MILLAN, LILIT HARUTYUNYAN
Exploratory PRO Assessments
Questionnaire | Description | Scales | Analyses
EORTC QLQ-C30 | Oncology-specific questionnaire | • Global health status (GHS)/QoL • Functioning scales: physical, emotional, cognitive, and social • Symptom scales: pain, fatigue, nausea/vomiting • Single-item scales: dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact | • Change from baseline • Time to definitive deterioration (clinically meaningful definitive deterioration during the study period, defined as a change of ≥10 points from baseline at either 2 or more consecutive time points, last PRO assessment, or death by the first survival follow-up visit)
EORTC QLQ-BR23 | Breast cancer–specific questionnaire | • Subscales: breast symptoms, arm symptoms, body image, sexual functioning, and systemic therapy side effects | • Change from baseline • Time to definitive deterioration
EQ-5D-5L | Generic questionnaire | • Self-rated health status (VAS) | • Time to definitive deterioration
PRO endpoints are reported for the following study time points(a):
Cycle 1 (baseline) | Cycle 2 | Every 4 cycles (cycle 6, 10, 14) | End of treatment
Completion(b) was comparable throughout treatment in both treatment groups, supporting interpretability of the longitudinal PRO analyses
EORTC QLQ-BR23, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 23; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EQ-5D-5L, EuroQol 5-Dimension 5-Level questionnaire; GHS, global health status; HR, hormone receptor; HRQoL, health-related quality of life; PRO, patient-reported outcome; QoL, quality of life; TDD, time to definitive deterioration; VAS, visual analog scale.
(a)PRO assessments began before infusion on day 1 of cycle 1; 1 cycle = 21 days. (b)The number of patients who completed at least one question from a questionnaire divided by the number of patients randomized within each treatment arm.
Dr. Carlos Barrios
Speaker panel: Carlos Barrios — Patient-reported outcomes (PROs) from DESTINY-Breast05: Health-related quality of life (HRQoL) with trastuzumab Deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients (Pts) with high-risk HER2-positive early breast cancer (eBC)
ALICANTE AUDITORIUM - HALL 6
PROs from DB05 presented by Carlos Barrios. Preserved QoL with T-DXd (vs T-DM1), with improvement in key domains (pain, arm symptoms) and worsening in social functioning. Overall, they confirm the role of adjuvant T-DXd for patients with high-risk RD. #ESMO26 #ESMOAmbassadors https://t.co/2zoMFUxKh7
[Slide 1]
[Photo of auditorium screen; speaker inset]
Overall HRQoL Outcomes Were Comparable, With Domain-Specific Differences Between T-DXd and T-DM1
TDD,a median (95% CI), months: T-DXd (n = 818) | T-DM1 (n = 817) | Hazard Ratio (95% CI)
EORTC QLQ-C30
GHS/QoL: 24.02 (22.64-NE) | 23.66 (22.64-25.26) | 1.15 (0.98-1.34)
Pain symptoms: 24.11 (23.75-31.70) | 22.74 (18.07-24.48) | 0.77 (0.65-0.90)
Physical functioning: 30.09 (30.09-NE) | 33.91 (NE-NE) | 1.17 (0.95-1.43)
Emotional functioning: 26.25 (24.02-NE) | 27.93 (27.93-NE) | 1.02 (0.85-1.22)
Social functioning: 24.15 (23.66-NE) | NE (26.58-NE) | 1.29 (1.08-1.54)
EORTC QLQ-BR23
Arm symptoms: 23.13 (18.04-24.15) | 17.54 (12.22-21.98) | 0.82 (0.70-0.95)
Breast symptoms: NE (26.48-NE) | NE (27.20-NE) | 0.83 (0.66-1.03)
EQ-5D-5L
VAS: 24.15 (23.36-29.80) | 23.85 (23.36-26.58) | 1.05 (0.89-1.24)
[Forest plot axis 0.4-1.8; Favors T-DXd / Favors T-DM1]
- There was no difference observed in TDD between T-DXd and T-DM1 across overall HRQoL, physical functioning, emotional functioning, breast symptoms, and EQ-5D-5L VAS
- T-DXd was associated with a longer time to deterioration in pain and arm symptoms compared with T-DM1, while T-DM1 was associated with a longer time to deterioration in social function compared with T-DXd during the study period
[Abbreviation footnotes - fine print, partly illegible]
Dr. Carlos Barrios
DESTINY-Breast05: TDXd for residual HER2+ dz
HRQOL maintained with both TDXd + T-DM1
TDXd assoc w/ longer time to deterioration in pain and arm symptoms c/w T-DM1
@OncoAlert #ESMO26 https://t.co/ffHDPkWvh6
[Slide 1]
Conclusions
- Overall, key HRQoL domains were maintained with both T-DXd and T-DM1 in patients with high-risk HER2-positive eBC who had residual invasive disease after neoadjuvant therapy
- PRO assessments were comparable between treatments, with some differences in selected domains:
o T-DXd was associated with a longer time to deterioration in pain and arm symptoms compared with T-DM1 during the study period
o T-DM1 was associated with a longer time to deterioration in social function compared with T-DXd during the study period
DESTINY-Breast05 HRQoL findings demonstrate preservation of patient-reported quality of life and, together with previously reported efficacy data, support T-DXd as a new standard of care in the post-neoadjuvant setting
eBC, early breast cancer; HER2, human epidermal growth factor receptor 2; HRQoL, health-related quality of life; PRO, patient-reported outcome; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan.
Dr. Carlos Barrios
[Slide 2]
Overall HRQoL Outcomes Were Comparable, With Domain-Specific Differences Between T-DXd and T-DM1
TDD,a median (95% CI), months: T-DXd (n = 818) | T-DM1 (n = 817) | Hazard Ratio (95% CI)
EORTC QLQ-C30
GHS/QoL: 24.02 (22.64-NE) | 23.66 (22.64-25.26) | 1.15 (0.98-1.34)
Pain symptoms: 24.11 (23.75-31.70) | 22.74 (18.07-24.48) | 0.77 (0.65-0.90)
Physical functioning: 30.09 (30.09-NE) | 33.91 (NE-NE) | 1.17 (0.95-1.43)
Emotional functioning: 26.25 (24.02-NE) | 27.93 (27.93-NE) | 1.02 (0.85-1.22)
Social functioning: 24.15 (23.66-NE) | NE (26.58-NE) | 1.29 (1.08-1.54)
EORTC QLQ-BR23
Arm symptoms: 23.13 (18.04-24.15) | 17.54 (12.22-21.98) | 0.82 (0.70-0.95)
Breast symptoms: NE (26.48-NE) | NE (27.20-NE) | 0.83 (0.66-1.03)
EQ-5D-5L
VAS: 24.15 (23.36-29.80) | 23.85 (23.36-26.58) | 1.05 (0.89-1.24)
[Forest plot axis 0.4-1.8; Favors T-DXd <- -> Favors T-DM1]
- There was no difference observed in TDD between T-DXd and T-DM1 across overall HRQoL, physical functioning, emotional functioning, breast symptoms, and EQ-5D-5L VAS
- T-DXd was associated with a longer time to deterioration in pain and arm symptoms compared with T-DM1, while T-DM1 was associated with a longer time to deterioration in social function compared with T-DXd during the study period
CI, confidence interval; EORTC QLQ-BR23, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 23; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; GHS, global health status; HRQoL, health-related quality of life; QoL, quality of life; NE, not estimable; TDD, time to definitive deterioration; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; VAS, visual analog scale.
TDD was analyzed using Kaplan-Meier methods and Cox proportional hazards models.
aClinically meaningful definitive deterioration during the study period, defined as a change of >=10 points from baseline at either 2 or more consecutive time points, last PRO assessment, or death by the first survival follow-up visit.
Dr. Carlos Barrios
More slides on this page
Conference slides shared by KOLs and presenters, with full OCR text available. All slides verified DESTINY-Breast 05 content.
[Slide 1]
16:30 - 18:15 Presidential Symposium |
CHAIRS: GIUSEPPE CURIGLIANO, BRIGETTE MA
FUTURE STUDIES NEEDED
HOW COULD WE INTEGRATE DB11 AND DB05?
Can we use a response-guided approach?
HP
pCR
X 14 cycles
ctDNA
cT≥3 or cN+
THP
Breast MRI
undetectable
Surgery
TDXd
HER2+ BC
x12 wks
(at C2D1)
response
RD
x14 cycles
Any HR status
Sara Tolaney
Check ctDNA:
If no response
Baseline &
Baseline breast MRI
Cycle Day 1
HP
Invited Discussant LBA1
for all patients
ctDNA
pCR
T-DXd for 4
X 14 cycles
Baseline tumor-informed
detectable
cycles
Surgery
ultrasensitive ctDNA for
(at C2D1)
RCB2/3
all patients
RD
ACx4-T-DM1x
Plasma samples for serial ctDNA testing
14 cycles
RCB1
"
"
T-DM1 X 14 cycles
Baseline
C2d1
(week 0)
(week 3)
Side adapted from Bia Sequi/Ada Waks
BERLIN AUDITORIUM - HUB 27
[Slide 1]
PREOPERATIVE/ADJUVANT THERAPY
See BINV-M 1 of 10 for Considerations for Those Receiving Preoperative/Adjuvant Systemic Therapy.
HR-Positive or -Negative and HER2-Positive9
Preferred:
Preoperative or adjuvant setting:
TCHP (Docetaxel/Carboplatin + Trastuzumab + Pertuzumab)
Adjuvant setting:
TCH (Docetaxel/Carboplatin + Trastuzumab)
If no residual disease after preoperative therapy or no preoperative therapy: Complete up to 1 year of HER2-targeted therapy with Trastuzumabh
(category 1) + Pertuzumab. If node positive at initial staging, Pertuzumab + Trastuzumab (category 1)
If residual disease after preoperative therapy:
Ado-trastuzumab emtansine (category 1) alone. If Ado-trastuzumab emtansine discontinued for toxicity, then Trastuzumab (category 1)
+ Pertuzumab to complete 1 year of therapy. If node positive at initial staging, Pertuzumab + Trastuzumab (category 1)J
Fam-trastuzumab deruxtecan-nxki (category 1) for those with high risk of recurrence defined as inoperable cancer (cT4, N0-3, M0 or cT1-3, N2-3,
M0) at presentation prior to neoadjuvant therapy or operable cancer (cT1-3, N0-1, M0) with axillary node-positive disease (ypN1-3) following
preoperative therapy.
[Slide 1]
Primary endpoint: IDFSᵃ
T-DXd
T-DM1
n= 818
n= 817
Patients with events, n (%)
51 (6.2)
102 (12.5)
3-year IDFS, % (95% CI)
92.4 (89.7-94.4)
83.7 (80.2-86.7)
HR (95 % CI)
0.47 (0.34-0.66)
1.0
P value
<0.0001b
Invasive Disease-Free Survival
0.8
Д8.7%
0.6
T-DXd (n = 818)
T-DM1 (n = 817)
Censor
0.0
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54
Time, months
Number at Risk:
T-DXd 818 788 781 776 771 768 758 753 731 684 634 544 440 380 370 275 218 212 129 92 90 46 14 14 0 0 0 0
T-DM1 817 781 769 760 745 734 719 708 687 632 599 527 417 355 337 233 186 177 120 84 79 38 14 13 4 1 1 0
53% reduction in the risk of invasive disease recurrence or death for T-DXd compared with T-DM1
HR, hazard ratio; IDFS, invasive disease-free survival; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan
Efficacy stopping boundary, P 0.0183.
MDFS is defined as the time from randomization until the date of first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, recurrence of ipsilateral locoregional invasive breast cancer, contralateral invasive breast
cancer, a distant disease recurrence, or death from any cause. Two-sided Pvalue from stratified log-rank test. Hazard ratio and 95% CI from stratified Cox proportional hazards model with stratification factor of operative status at disease
presentation
Dr Charles E Geyer Jr
Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
BERLIN
DESTINY-Breast05
ESMO
congress
Trial Design
DESTINY-Breast05 Trial Design
DESTINY-Breast 05 is a phase 3, global, randomized, open-label trial evaluating T-DXd (Enhertu) vs. T-DM1 (Kadcyla) in adult patients with high-risk HER2-positive early breast cancer who have residual invasive disease following neoadjuvant therapy.
Study Design
Phase 3, randomized, open-label, multicenter, global trial; 1,635 patients randomized 1:1 to 14 cycles of either T-DXd or T-DM1.
Population
Adult patients with centrally confirmed HER2-positive (IHC 3+ or ISH+) early breast cancer with residual invasive disease in the breast and/or axillary nodes after neoadjuvant chemotherapy plus HER2-directed therapy — a high-risk-of-recurrence population.
Interventions
Intravenous T-DXd at 5.4 mg/kg every 3 weeks for 14 cycles versus intravenous T-DM1 at 3.6 mg/kg every 3 weeks for 14 cycles.
Enhertu (fam-trastuzumab deruxtecan-nxki) — approved May 15, 2026 — As adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment.
Dosing: 5.4 mg/kg IV every 3 weeks for 14 cycles. Black-box warning: interstitial lung disease / pneumonitis and embryo-fetal toxicity.
DESTINY-Breast05 (NCT04622319) is a Phase 3, global, randomized, open-label trial of adjuvant trastuzumab deruxtecan (T-DXd, Enhertu) versus T-DM1 (Kadcyla) in high-risk HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy. See Trial Design.
Is adjuvant T-DXd (Enhertu) FDA approved for HER2+ early breast cancer?
Yes. On May 15, 2026 the FDA approved Enhertu as adjuvant treatment for HER2-positive breast cancer with residual invasive disease after neoadjuvant trastuzumab-based and taxane-based treatment, based on DESTINY-Breast05. See FDA Approval.
What were the DESTINY-Breast05 iDFS results?
T-DXd improved invasive disease-free survival versus T-DM1 at the interim analysis (HR 0.47). Confidence interval, 3-year rates and source: At a Glance.
Is overall survival data mature in DESTINY-Breast05?
No. Overall survival was immature at the interim analysis and the final analysis is pending. See At a Glance.
How is adjuvant Enhertu dosed and what are its warnings?
Enhertu is given intravenously every 3 weeks for 14 cycles and carries a boxed warning for interstitial lung disease/pneumonitis and embryo-fetal toxicity. Dose and ILD rates: At a Glance.