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AstraZeneca and Daiichi Sankyo’s ENHERTU additionally improved median general survival by greater than 6 months vs. chemotherapy in all sufferers evaluated in DESTINY-Breast04
ENHERTU met the first endpoint of progression-free survival in sufferers with HR-positive illness, lowering the chance of illness development or loss of life by 49% vs. chemotherapy
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ENHERTU is the primary HER2-directed remedy to display a survival profit on this inhabitants, doubtlessly redefining remedy for about half of all sufferers with breast most cancers
WILMINGTON, Del.–(BUSINESS WIRE)–Detailed constructive outcomes from the pivotal DESTINY-Breast04 Part III trial confirmed that ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated superior and clinically significant progression-free survival (PFS) and general survival (OS) in beforehand handled sufferers with HER2-low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) unresectable and/or metastatic breast most cancers with hormone receptor (HR) constructive or HR-negative illness versus normal of care doctor’s alternative of chemotherapy. Outcomes might be offered in the course of the Plenary Session right now on the 2022 American Society of Medical Oncology (ASCO) Annual Assembly, and have been concurrently printed in The New England Journal of Medication.
ENHERTU is a particularly engineered HER2-directed antibody drug conjugate (ADC) being collectively developed and commercialized by AstraZeneca and Daiichi Sankyo.
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Within the main endpoint evaluation for DESTINY-Breast04, ENHERTU demonstrated a 49% discount within the danger of illness development or loss of life versus doctor’s alternative of chemotherapy in sufferers with HER2-low metastatic breast most cancers with HR-positive illness (PFS hazard ratio [HR] 0.51; 95% confidence interval [CI]: 0.40-0.64; p<0.001). A median PFS of 10.1 months was seen in sufferers handled with ENHERTU in comparison with 5.4 months with chemotherapy, as assessed by blinded impartial central evaluate (BICR).
Outcomes additionally confirmed a 36% discount within the danger of loss of life with ENHERTU in comparison with chemotherapy in sufferers with HR-positive illness (OS HR 0.64; 95% CI: 0.48-0.86; p=0.003) with a median OS of 23.9 months with ENHERTU versus 17.5 months with chemotherapy, assembly a key secondary endpoint of the trial.
Moreover, information confirmed constant efficacy for ENHERTU within the general trial inhabitants of sufferers with HER2-low metastatic breast most cancers with HR-positive or HR-negative illness and throughout ranges of HER2 expression (IHC 1+ and IHC 2+/ISH-). In the important thing secondary endpoint evaluation of PFS by BICR in all sufferers, the same 50% discount within the danger of illness development or loss of life was noticed between ENHERTU and chemotherapy (PFS HR 0.50; 95% CI:0.40-0.63; p<0.001). Outcomes additionally confirmed a 36% discount within the danger of loss of life with ENHERTU in comparison with chemotherapy (OS HR 0.64; 95% CI: 0.49-0.84; p=0.001) with a median OS of 23.4 months for ENHERTU versus 16.8 months with chemotherapy.
Shanu Modi, MD, Medical Oncologist, Memorial Sloan Kettering Most cancers Heart, US and Principal Investigator for the trial, stated: “The outcomes of DESTINY-Breast04 present for the primary time {that a} HER2-directed remedy can present a survival profit to sufferers with low HER2 expression, indicating we should rethink the way in which we categorize sufferers with metastatic breast most cancers. The efficacy seen with ENHERTU additionally reinforces the potential to ascertain a brand new normal of look after greater than half of all sufferers with breast most cancers presently categorized as having HER2-negative illness, however who even have tumors with low HER2 expression.”
Susan Galbraith, Government Vice President, Oncology R&D, AstraZeneca stated: “In the present day’s outcomes signify a pivotal second demonstrating the potential for ENHERTU to redefine the remedy of HER2-targetable cancers. DESTINY-Breast04 validates focusing on the decrease finish of the spectrum of HER2 expression, since ENHERTU diminished the chance of illness development or loss of life throughout all sorts of sufferers within the trial by half, and diminished the chance of loss of life by over a 3rd. We should now evolve the way in which we classify and deal with metastatic breast most cancers to make sure these sufferers are successfully recognized and handled.”
Ken Takeshita, World Head, R&D, Daiichi Sankyo stated: “As modern analysis organizations, extending the survival for sufferers is one in all our main objectives as we search to establish doubtlessly new remedy choices for sufferers with metastatic breast most cancers. These doubtlessly practice-changing information present that DESTINY-Breast04 takes us one step nearer to reaching this aim, as ENHERTU is the primary HER2-directed drugs to display a survival profit in sufferers with HER2-low metastatic breast most cancers. We’re honored by the popularity these vital findings are receiving at one of many world’s most outstanding oncology conferences in addition to in one of many main medical journals.”
Abstract of outcomes: DESTINY-Breast04
Efficacy Measure |
HR-Constructive (n=494)i |
All Sufferers (n=557) |
HR-Unfavorable (n=58)i |
|||
ENHERTU (5.4 mg/kg) (n=331) |
Chemotherapy (n=163) |
ENHERTU (5.4 mg/kg) (n=373) |
Chemotherapy (n=184) |
ENHERTU (5.4 mg/kg) (n=40) |
Chemotherapy (n=18) |
|
PFS |
||||||
Median PFS (months)ii |
10.1 (9.5-11.5) |
5.4 (4.4-7.1) |
9.9 (9.0-11.3) |
5.1 (4.2-6.8) |
8.5 (4.3-11.7) |
2.9 (1.4-5.1) |
Hazard Ratio (95% CI) |
0.51 (0.40-0.64) |
0.50 (0.40-0.63) |
0.46 (0.24-0.89) |
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p-value |
p<0.001 |
p<0.001 |
|
|||
OS |
||||||
Median OS (months) |
23.9 (20.8-24.8) |
17.5 (15.2-22.4) |
23.4 (20.0-24.8) |
16.8 (14.5-20.0) |
18.2 (13.6-NE) |
8.3 (5.6-20.6) |
Hazard Ratio (95% CI) |
HR 0.64 (0.48-0.86) |
HR 0.64 (0.49-0.84) |
HR 0.48 (0.24-0.95) |
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p-value |
p=0.003 |
p=0.001 |
|
|||
Confirmed ORR (%) (95% CI)ii,iii |
52.6% (47.0-58.0) |
16.3% (11.0-22.8) |
52.3% (47.1-57.4) |
16.3% (11.3-22.5) |
50.0% (33.8-66.2) |
16.7% (3.6-41.4) |
Full Response (%) |
3.6% |
0.6% |
3.5% |
1.1% |
2.5% |
5.6% |
Partial Response (%) |
49.2% |
15.7% |
49.1% |
15.2% |
47.5% |
11.1% |
Secure Illness (%) |
35.1% |
50.0% |
34.6% |
49.5% |
30.0% |
44.4% |
Progressive Illness (%) (95% CI) |
7.8% |
21.1% |
8.3% |
22.3% |
12.5% |
33.3% |
Median DoR (months)ii |
10.7 |
6.8 |
10.7 |
6.8 |
8.6 |
4.9 |
CBR (%)ii, iv |
71.2% |
34.3% |
70.2% |
33.7% |
62.5% |
27.8% |
DCR (%)iv,v |
88.0% |
66.3% |
87.1% |
65.8% |
80.0% |
61.1% |
CI, confidence interval; CBR, medical profit price; DCR, illness management price; DoR, Period of Response; HR, hazard ratio; NE, not evaluable; ORR, general response price; OS, general survival; PFS, progression-free survival |
i For the first finish level (PFS within the HR-positive cohort) and key secondary finish factors (PFS amongst all sufferers and OS within the HR-positive cohort and amongst all sufferers), the HR standing relies on information collected with using the interactive Net-response and voice-response system on the time of randomization, which incorporates sufferers who have been mis-stratified. For the opposite finish factors, HR standing relies on information from the digital information seize that was corrected for mis-stratification |
ii As assessed by BICR |
iii ORR is (Full Response + Partial Response) |
iv CBR is Full Response + Partial Response + Secure Illness (≥ 6 months) |
v DCR is (Full Response + Partial Response + Secure Illness) |
In an exploratory evaluation of sufferers with HR-negative illness (n=58), median PFS was 8.5 months with ENHERTU versus 2.9 months with chemotherapy (PFS HR 0.46; 95% CI: 0.24-0.89) and median OS was 18.2 months with ENHERTU versus 8.3 months with chemotherapy (OS HR 0.48; 95% CI: 0.24-0.95).
The protection profile of ENHERTU was in keeping with earlier medical trials with no new security considerations recognized. The most typical Grade 3 or larger treatment-emergent adversarial occasions have been neutropenia (13.7%), anaemia (8.1%), fatigue (7.5%), leukopenia (6.5%), thrombocytopenia (5.1%), and nausea (4.6%).
Interstitial lung illness (ILD) or pneumonitis charges have been in keeping with that noticed in late-line HER2-positive breast most cancers trials of ENHERTU with a decrease price of Grade 5 ILD noticed, as decided by an impartial adjudication committee. The bulk (10%) have been primarily low Grade (Grade 1 or 2) with 5 Grade 3 (1.3%), no Grade 4 and three Grade 5 (0.8%) occasions reported.
U.S. Essential Security Info for ENHERTU
Indications
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the remedy of grownup sufferers with:
-
Unresectable or metastatic HER2-positive breast most cancers who’ve acquired a previous anti-HER2-based routine both:
- Within the metastatic setting, or
- Within the neoadjuvant or adjuvant setting and have developed illness recurrence throughout or inside six months of finishing remedy
- Domestically superior or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who’ve acquired a previous trastuzumab-based routine
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY |
|
|
Contraindications
None.
Warnings and Precautions
Interstitial Lung Illness / Pneumonitis
Extreme, life-threatening, or deadly interstitial lung illness (ILD), together with pneumonitis, can happen in sufferers handled with ENHERTU. Advise sufferers to right away report cough, dyspnea, fever, and/or any new or worsening respiratory signs. Monitor sufferers for indicators and signs of ILD. Promptly examine proof of ILD. Consider sufferers with suspected ILD by radiographic imaging. Contemplate session with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU till resolved to Grade 0, then if resolved in ≤28 days from date of onset, preserve dose. If resolved in >28 days from date of onset, scale back dose one stage. Contemplate corticosteroid remedy as quickly as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equal). For symptomatic ILD/pneumonitis (Grade 2 or better), completely discontinue ENHERTU. Promptly provoke systemic corticosteroid remedy as quickly as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equal) and proceed for at the very least 14 days adopted by gradual taper for at the very least 4 weeks.
Metastatic Breast Most cancers
In medical research, of the 491 sufferers with unresectable or metastatic HER2-positive breast most cancers handled with ENHERTU 5.4 mg/kg, ILD occurred in 13% of sufferers. Deadly outcomes as a result of ILD and/or pneumonitis occurred in 1.4% of sufferers handled with ENHERTU. Median time to first onset was 5.5 months (vary: 1.1 to twenty.8).
Domestically Superior or Metastatic Gastric Most cancers
In DESTINY-Gastric01, of the 125 sufferers with regionally superior or metastatic HER2‑constructive gastric or GEJ adenocarcinoma handled with ENHERTU 6.4 mg/kg, ILD occurred in 10% of sufferers. Median time to first onset was 2.8 months (vary: 1.2 to 21.0).
Neutropenia
Extreme neutropenia, together with febrile neutropenia, can happen in sufferers handled with ENHERTU. Monitor full blood counts previous to initiation of ENHERTU and prior to every dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Depend [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU till resolved to Grade 2 or much less, then preserve dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU till resolved to Grade 2 or much less. Cut back dose by one stage. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for greater than 1 hour), interrupt ENHERTU till resolved. Cut back dose by one stage.
Metastatic Breast Most cancers
In medical research, of the 491 sufferers with unresectable or metastatic HER2-positive breast most cancers who acquired ENHERTU 5.4 mg/kg, a lower in neutrophil rely was reported in 68% of sufferers. Eighteen p.c had Grade 3 or 4 lower in neutrophil rely. Median time to first onset of decreased neutrophil rely was 22 days (vary: 6 to 664). Febrile neutropenia was reported in 1.2% of sufferers.
Domestically Superior or Metastatic Gastric Most cancers
In DESTINY-Gastric01, of the 125 sufferers with regionally superior or metastatic HER2‑constructive gastric or GEJ adenocarcinoma handled with ENHERTU 6.4 mg/kg, a lower in neutrophil rely was reported in 72% of sufferers. Fifty-one p.c had Grade 3 or 4 decreased neutrophil rely. Median time to first onset of decreased neutrophil rely was 16 days (vary: 4 to 187). Febrile neutropenia was reported in 4.8% of sufferers.
Left Ventricular Dysfunction
Sufferers handled with ENHERTU could also be at elevated danger of growing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) lower has been noticed with anti-HER2 therapies, together with ENHERTU. Assess LVEF previous to initiation of ENHERTU and at common intervals throughout remedy as clinically indicated. Handle LVEF lower by way of remedy interruption. When LVEF is >45% and absolute lower from baseline is 10-20%, proceed remedy with ENHERTU. When LVEF is 40-45% and absolute lower from baseline is <10%, proceed remedy with ENHERTU and repeat LVEF evaluation inside 3 weeks. When LVEF is 40-45% and absolute lower from baseline is 10-20%, interrupt ENHERTU and repeat LVEF evaluation inside 3 weeks. If LVEF has not recovered to inside 10% from baseline, completely discontinue ENHERTU. If LVEF recovers to inside 10% from baseline, resume remedy with ENHERTU on the identical dose. When LVEF is <40% or absolute lower from baseline is >20%, interrupt ENHERTU and repeat LVEF evaluation inside 3 weeks. If LVEF of <40% or absolute lower from baseline of >20% is confirmed, completely discontinue ENHERTU. Completely discontinue ENHERTU in sufferers with symptomatic congestive coronary heart failure. Remedy with ENHERTU has not been studied in sufferers with a historical past of clinically vital cardiac illness or LVEF <50% previous to initiation of remedy.
Metastatic Breast Most cancers
Within the 491 sufferers with unresectable or metastatic HER2-positive breast most cancers who acquired ENHERTU 5.4 mg/kg, 13 circumstances (2.6%) of asymptomatic LVEF lower have been reported.
Domestically Superior or Metastatic Gastric Most cancers
In DESTINY-Gastric01, of the 125 sufferers with regionally superior or metastatic HER2‑constructive gastric or GEJ adenocarcinoma handled with ENHERTU 6.4 mg/kg, no medical adversarial occasions of coronary heart failure have been reported; nevertheless, on echocardiography, 8% have been discovered to have asymptomatic Grade 2 lower in LVEF.
Embryo-Fetal Toxicity
ENHERTU may cause fetal hurt when administered to a pregnant lady. Advise sufferers of the potential dangers to a fetus. Confirm the being pregnant standing of females of reproductive potential previous to the initiation of ENHERTU. Advise females of reproductive potential to make use of efficient contraception throughout remedy and for at the very least 7 months following the final dose of ENHERTU. Advise male sufferers with feminine companions of reproductive potential to make use of efficient contraception throughout remedy with ENHERTU and for at the very least 4 months after the final dose of ENHERTU.
Further Dose Modifications
Thrombocytopenia
For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU till resolved to Grade 1 or much less, then preserve dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU till resolved to Grade 1 or much less. Cut back dose by one stage.
Antagonistic Reactions
Metastatic Breast Most cancers
The pooled security inhabitants for sufferers with metastatic breast most cancers displays publicity to ENHERTU at 5.4 mg/kg given as an intravenous infusion as soon as each 3 weeks (21-day cycle) in 491 sufferers in DESTINY-Breast03, DESTINY-Breast01, and Research DS8201-A-J101. The median period of remedy was 13 months (vary: 0.7 to 37). On this pooled security inhabitants, the most typical (≥20%) adversarial reactions, together with laboratory abnormalities, have been nausea (78%), decreased white blood cell rely (74%), decreased hemoglobin (68%), decreased neutrophil rely (68%), elevated aspartate aminotransferase (58%), fatigue (57%), decreased lymphocyte rely (56%), vomiting (50%), decreased platelet rely (49%), elevated alanine aminotransferase (48%), elevated blood alkaline phosphatase (45%), alopecia (41%), constipation (35%), hypokalemia (33%), decreased urge for food (32%), diarrhea (31%), musculoskeletal ache (28%), elevated transaminases (27%), respiratory an infection (24%), headache (21%), and stomach ache (21%).
DESTINY-Breast03
The protection of ENHERTU was evaluated in 257 sufferers with unresectable or metastatic HER2-positive breast most cancers who acquired at the very least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast03. ENHERTU was administered by intravenous infusion as soon as each three weeks. The median period of remedy was 14 months (vary: 0.7 to 30).
Critical adversarial reactions occurred in 19% of sufferers receiving ENHERTU. Critical adversarial reactions in >1% of sufferers who acquired ENHERTU have been vomiting, interstitial lung illness, pneumonia, pyrexia, and urinary tract an infection. Fatalities as a result of adversarial reactions occurred in 0.8% of sufferers together with COVID-19 and sudden loss of life (one affected person every).
ENHERTU was completely discontinued in 14% of sufferers, of which ILD/pneumonitis accounted for 8%. Dose interruptions as a result of adversarial reactions occurred in 44% of sufferers handled with ENHERTU. Probably the most frequent adversarial reactions (>2%) related to dose interruption have been neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis. Dose reductions occurred in 21% of sufferers handled with ENHERTU. Probably the most frequent adversarial reactions (>2%) related to dose discount have been nausea, neutropenia, and fatigue.
The most typical (≥20%) adversarial reactions, together with laboratory abnormalities, have been nausea (76%), decreased white blood cell rely (74%), decreased neutrophil rely (70%), elevated aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte rely (55%), elevated alanine aminotransferase (53%), decreased platelet rely (52%), fatigue (49%), vomiting (49%), elevated blood alkaline phosphatase (49%), alopecia (37%), hypokalemia (35%), constipation (34%), musculoskeletal ache (31%), diarrhea (29%), decreased urge for food (29%), respiratory an infection (22%), headache (22%), stomach ache (21%), elevated blood bilirubin (20%), and stomatitis (20%).
Domestically Superior or Metastatic Gastric Most cancers
The protection of ENHERTU was evaluated in 187 sufferers with regionally superior or metastatic HER2‑constructive gastric or GEJ adenocarcinoma in DESTINY‑Gastric01. Sufferers intravenously acquired at the very least one dose of both ENHERTU (N=125) 6.4 mg/kg as soon as each three weeks or both irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median period of remedy was 4.6 months (vary: 0.7 to 22.3) within the ENHERTU group and a couple of.8 months (vary: 0.5 to 13.1) within the irinotecan/paclitaxel group.
Critical adversarial reactions occurred in 44% of sufferers receiving ENHERTU 6.4 mg/kg. Critical adversarial reactions in >2% of sufferers who acquired ENHERTU have been decreased urge for food, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities as a result of adversarial reactions occurred in 2.4% of sufferers: disseminated intravascular coagulation, massive gut perforation, and pneumonia occurred in a single affected person every (0.8%).
ENHERTU was completely discontinued in 15% of sufferers, of which ILD accounted for six%. Dose interruptions as a result of adversarial reactions occurred in 62% of sufferers handled with ENHERTU. Probably the most frequent adversarial reactions (>2%) related to dose interruption have been neutropenia, anemia, decreased urge for food, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, higher respiratory tract an infection, diarrhea, and hypokalemia. Dose reductions occurred in 32% of sufferers handled with ENHERTU. Probably the most frequent adversarial reactions (>2%) related to dose discount have been neutropenia, decreased urge for food, fatigue, nausea, and febrile neutropenia.
The most typical (≥20%) adversarial reactions, together with laboratory abnormalities, have been decreased hemoglobin (75%), decreased white blood cell rely (74%), decreased neutrophil rely (72%), decreased lymphocyte rely (70%), decreased platelet rely (68%), nausea (63%), decreased urge for food (60%), elevated aspartate aminotransferase (58%), fatigue (55%), elevated blood alkaline phosphatase (54%), elevated alanine aminotransferase (47%), diarrhea (32%), hypokalemia (30%), vomiting (26%), constipation (24%), elevated blood bilirubin (24%), pyrexia (24%), and alopecia (22%).
Use in Particular Populations
- Being pregnant: ENHERTU may cause fetal hurt when administered to a pregnant lady. Advise sufferers of the potential dangers to a fetus. There are medical concerns if ENHERTU is utilized in pregnant girls, or if a affected person turns into pregnant inside 7 months following the final dose of ENHERTU.
- Lactation: There aren’t any information concerning the presence of ENHERTU in human milk, the consequences on the breastfed youngster, or the consequences on milk manufacturing. Due to the potential for critical adversarial reactions in a breastfed youngster, advise girls to not breastfeed throughout remedy with ENHERTU and for 7 months after the final dose.
- Females and Males of Reproductive Potential: Being pregnant testing: Confirm being pregnant standing of females of reproductive potential previous to initiation of ENHERTU. Contraception: Females: ENHERTU may cause fetal hurt when administered to a pregnant lady. Advise females of reproductive potential to make use of efficient contraception throughout remedy with ENHERTU and for at the very least 7 months following the final dose. Males: Advise male sufferers with feminine companions of reproductive potential to make use of efficient contraception throughout remedy with ENHERTU and for at the very least 4 months following the final dose. Infertility: ENHERTU might impair male reproductive perform and fertility.
- Pediatric Use: Security and effectiveness of ENHERTU haven’t been established in pediatric sufferers.
- Geriatric Use: Of the 491 sufferers with HER2-positive breast most cancers handled with ENHERTU 5.4 mg/kg, 22% have been ≥65 years and 4% have been ≥75 years. No general variations in efficacy inside medical research have been noticed between sufferers ≥65 years of age in comparison with youthful sufferers. There was a better incidence of Grade 3-4 adversarial reactions noticed in sufferers aged ≥65 years (60%) as in comparison with youthful sufferers (49%). Of the 125 sufferers with regionally superior or metastatic HER2‑constructive gastric or GEJ adenocarcinoma handled with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% have been ≥65 years and 14% have been ≥75 years. No general variations in efficacy or security have been noticed between sufferers ≥65 years of age in comparison with youthful sufferers.
- Renal Impairment: The next incidence of Grade 1 and a couple of ILD/pneumonitis has been noticed in sufferers with reasonable renal impairment. Monitor sufferers with reasonable or extreme renal impairment.
- Hepatic Impairment: In sufferers with reasonable hepatic impairment, as a result of doubtlessly elevated publicity, carefully monitor for elevated toxicities associated to the topoisomerase inhibitor.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
Please see accompanying full Prescribing Informat
Contacts
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