SAFETY

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DATROWAY has serious Warnings and Precautions. Click here for more information.

Common adverse reactions in the pooled locally advanced or metastatic EGFRm NSCLC population¹*

The majority of adverse reactions were Grade 1 or 2 with DATROWAY*

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Common adverse reactions (≥10%) in patients with locally advanced or metastatic EGFRm NSCLC on DATROWAY		DATROWAY (n=125)
		All Grades, %	Grades 3 or 4, %
Gastrointestinal disorders	Stomatitis^†	71	9
	Nausea	50	0
	Constipation	31	0
	Vomiting	16	0.8
	Diarrhea	12	0
Skin and subcutaneous tissue disorders	Alopecia	49	0
	Rash^†	20	0.8
	Pruritus	12	0
General disorders and administration site conditions	Fatigue^‡	42	6
Musculoskeletal and connective tissue disorders	Musculoskeletal pain	22	0.8
Metabolism and nutrition disorders	Decreased appetite	20	1.6
Infections and infestations	COVID-19^†	19	2.4
Respiratory, thoracic, and mediastinal disorders	Cough^†	18	0
Respiratory, thoracic, and mediastinal disorders	Dyspnea	11	2.4
Eye disorders	Dry eye	13	0
Eye disorders	Keratitis^§	12	2.4
Injury, poisoning and procedural complications	Infusion-related reaction^†	13	0
Nervous system disorders	Headache	13	0

Grade ≥3 ARs³

24%

Discontinuation rate due to ARs

8%

Dose modifications due to ARs

Dosage interruptions: 43%
Dose reductions: 26%

Other clinically relevant ARs reported in <10% of patients included:

Dry skin
Blurred vision
Abdominal pain
Conjunctivitis
Dry mouth
ILD/pneumonitis
Skin hyperpigmentation
Increased lacrimation
Visual impairment

Events were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

^*The pooled safety population reflects exposure to DATROWAY 6 mg/kg IV every 3 weeks in 125 patients with locally advanced or metastatic EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01.

^†Includes other related terms.

^‡Includes fatigue, asthenia, and malaise.

^§Includes corneal disorder, corneal erosion, keratitis, punctate keratitis, and ulcerative keratitis.

Laboratory abnormalities in the pooled locally advanced or metastatic EGFRm NSCLC population¹*

The majority of laboratory abnormalities were Grade 1 or 2

Select laboratory abnormalities (≥20%) that worsened from baseline in patients who received DATROWAY across three clinical trials*

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Laboratory Abnormality		DATROWAY
Laboratory Abnormality		All grades, %	Grades 3 or 4, %
Hematology	Decreased hemoglobin	34	4.8
	Decreased lymphocytes	32	11
	Decreased white blood cell count	27	1.6
Chemistry	Increased calcium	31	0
	Increased AST	28	2.4
	Increased lactate dehydrogenase	23	0
	Increased ALT	20	2.4

The denominator used to calculate the rate varied from 115 to 124 based on the number of patients with a baseline value and at least one post-treatment value. Frequencies were based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 grade-derived laboratory abnormalities.

*The pooled safety population reflects exposure to DATROWAY 6 mg/kg IV every 3 weeks in 125 patients with locally advanced or metastatic EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01.

Select adverse reactions in the pooled locally advanced or metastatic EGFRm NSCLC population^1,3*

In the EGFRm NSCLC pooled patient population, adverse reactions of interest were mostly Grade 1 or 2

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Select adverse reactions	DATROWAY (n=125)
Select adverse reactions	Grade 1, %	Grade 2, %	Grade ≥3, %	Discontinuation rate, %
Stomatitis	37	26	9	0
Keratitis	6	4	2.4	0.8
Dry eye	11	1.6	0	0
Adjudicated drug-related ILD	0.8	2.4	0.8	2.4

No Grade 5 adverse reactions of special interest were observed in the pooled EGFRm NSCLC population.

*The pooled safety population reflects exposure to DATROWAY 6 mg/kg IV every 3 weeks in 125 patients with locally advanced or metastatic EGFRm NSCLC in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01.¹

Defining Grade 1 to 2 select adverse reactions^1,8
Stomatitis^8†

Grade 1: Asymptomatic or mild symptoms

Grade 2: Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated

Keratitis^1,8‡

Grade 1: Asymptomatic; clinical or diagnostic observations only

Grade 2: Symptomatic; moderate decrease in visual acuity

Dry eye^1,8‡

Grade 1: Asymptomatic; clinical or diagnostic observations only; symptoms may be relieved by lubricants

Grade 2: Symptomatic; moderate decrease in visual acuity

Adjudicated drug-related ILD^1,8‡

Grade 1: Asymptomatic; consider corticosteroid treatment

Grade 2: Symptomatic; promptly initiate corticosteroid treatment; limiting instrumental activities of daily living

^†Grades are based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.^1,8

^‡Grades are based on both the NCI CTCAE and the full Prescribing Information for DATROWAY.^1,8

Grades shown here do not encompass all grades included in NCI CTCAE. Please refer to guidance on DATROWAY dosing modifications and adverse reaction management.

See additional guidance for select adverse reactions

Warnings and Precautions

The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 927 patients from TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01, and another clinical trial.

ILD/pneumonitis (locally advanced or metastatic NSCLC)*

DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01, ILD/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to onset for ILD was 1.4 months (range: 0.2-9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 79% (26/33) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 45% of patients

Ocular adverse reactions (locally advanced or metastatic NSCLC and other solid tumors)

DATROWAY can cause ocular ARs including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision. In the pooled safety population, ocular ARs occurred in 36% of patients treated with DATROWAY. Twenty patients (2.2%) experienced Grade 3 ocular ARs, which included keratitis and blurred vision, and one patient experienced a Grade 4 ocular AR of conjunctival hemorrhage. The most common (≥5%) ocular ARs were dry eye (17%), keratitis (14%), and increased lacrimation (7%). The median time to onset for ocular ARs was 2.3 months (range: 0.03 months to 23.2 months). Of the patients who experienced ocular ARs, 39% had complete resolution, and 10% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow-up). Ocular ARs led to dosage interruption in 3.6% of patients, dosage reductions in 2.5% of patients, and permanent discontinuation of DATROWAY in 1% of patients

Stomatitis (locally advanced or metastatic NSCLC and other solid tumors)

DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis. In the pooled safety population, stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to first onset of stomatitis was 0.5 months (range: 0.03-18.6 months). Stomatitis led to dosage interruption in 6% of patients, dosage reductions in 11% of patients, and permanent discontinuation of DATROWAY in 0.5% of patients

Embryo-fetal toxicity

DATROWAY can cause embryo-fetal harm

*A higher incidence of ILD/pneumonitis has been observed in patients with mild and moderate renal impairment (creatinine clearance [CLcr] 30 to <90 mL/min).¹

Additional safety data for DATROWAY
The safety of DATROWAY was evaluated in 125 patients with locally advanced or metastatic EGFRm NSCLC from TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01

Median duration of treatment:

6.1 months (range: 0.7-41.7 months)

Serious adverse reactions (>1% of patients):

COVID-19 (4%), stomatitis (2.4%), and pneumonia (1.6%)

Fatal adverse reactions occurred in 1.6% of patients who received DATROWAY, due to death not otherwise specified

Adverse reactions associated with discontinuations and dose modifications:

Discontinuation (>1% of patients) included ILD/pneumonitis (2.4%) and abnormal hepatic function (1.6%)

Dosage interruptions (>1% of patients) included COVID-19 (13%), stomatitis (7%), fatigue (6%), pneumonia (4%), anemia (2.4%), amylase increased (2.4%), keratitis (2.4%), ILD/pneumonitis (1.6%), decreased appetite (1.6%), dyspnea (1.6%), rash (1.6%), and infusion-related reaction (1.6%)

Dose reduction (>1% of patients) included stomatitis (14%), keratitis (1.6%), fatigue (1.6%), decreased weight (1.6%), and COVID-19 (1.6%)

ADC, antibody drug conjugate; ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; EGFRm, epidermal growth factor receptor-mutated; ILD, interstitial lung disease; IV, intravenous; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NSCLC, non-small cell lung cancer; Q3W, every 3 weeks; Trop-2, trophoblast cell surface antigen 2.

INDICATION AND IMPORTANT SAFETY INFORMATION

WARNING: INTERSTITIAL LUNG DISEASE AND EMBRYO-FETAL TOXICITY

Severe and fatal cases of ILD/pneumonitis have been reported with DATROWAY. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.
Exposure to DATROWAY during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

INDICATION

DATROWAY^® is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease/Pneumonitis

DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis.

Locally Advanced or Metastatic NSCLC

In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01, ILD/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to onset for ILD was 1.4 months (range: 0.2 months to 9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 79% (26/33) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 45% of patients.

Patients were excluded from clinical studies for a history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis.

Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

Withhold DATROWAY in patients with suspected ILD/pneumonitis and permanently discontinue DATROWAY if ≥Grade 2 ILD/pneumonitis is confirmed.

Ocular Adverse Reactions

DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision.

Locally Advanced or Metastatic NSCLC and Other Solid Tumors

In patients with locally advanced or metastatic NSCLC and other solid tumors, ocular adverse reactions occurred in 36% of patients treated with DATROWAY. Twenty patients (2.2%) experienced Grade 3 ocular adverse reactions, which included keratitis, dry eye, and blurred vision, and one patient experienced a Grade 4 ocular adverse reaction of conjunctival hemorrhage. The most common (≥5%) ocular adverse reactions were dry eye (17%), keratitis (14%), and increased lacrimation (7%). The median time to onset for ocular adverse reactions was 2.3 months (range: 0.03 months to 23.2 months). Of the patients who experienced ocular adverse reactions, 39% had complete resolution, and 10% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to dosage interruption in 3.6% of patients, dosage reductions in 2.5% of patients, and permanent discontinuation of DATROWAY in 1% of patients.

Patients with clinically significant corneal disease were excluded from clinical studies.

Advise patients to use preservative-free lubricant eye drops several times daily for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, annually while on treatment, at end of treatment, and as clinically indicated.

Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, withhold, reduce the dose, or permanently discontinue DATROWAY based on severity.

Stomatitis

DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis.

Locally Advanced or Metastatic NSCLC and Other Solid Tumors

In patients with locally advanced or metastatic NSCLC and other solid tumors, stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to first onset of stomatitis was 0.5 months (range: 0.03 months to 18.6 months). Stomatitis led to dosage interruption in 6% of patients, dosage reductions in 11% of patients, and permanent discontinuation of DATROWAY in 0.5% of patients.

Advise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY.

Monitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue DATROWAY.

Embryo-Fetal Toxicity

Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells.

Advise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose.

ADVERSE REACTIONS

Locally Advanced or Metastatic NSCLC and Other Solid Tumors

The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY as a single agent at 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in 927 patients in TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01, and other clinical trials. Among these patients who received DATROWAY, 45% were exposed for 6 months or longer and 19% were exposed for greater than one year. In this pooled safety population, the most common (≥ 20%) adverse reactions were stomatitis (63%), nausea (52%), fatigue (45%), alopecia (38%), constipation (28%), decreased appetite (23%), rash (23%), vomiting (22%), and musculoskeletal pain (20%). In this pooled safety population, the most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (9%) and decreased hemoglobin (3.5%).

Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01

The safety of DATROWAY was evaluated in 125 patients with EGFR-mutated NSCLC who received DATROWAY 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in TROPION-Lung05 and TROPION-Lung01 as well as TROPION-PanTumor01. Among these patients, the median duration of treatment was 6.1 months (range 0.7 months to 41.7 months).

The median age was 63 years (range: 36 to 81), 56% of patients were <65 years, 62% of patients were female; 66% were Asian, 26% were White, 0.8% were Black, 6% were other races; and 2.4% were of Hispanic ethnicity.

Serious adverse reactions occurred in 26% of patients who received DATROWAY. Serious adverse reactions in >1% of patients who received DATROWAY were COVID-19 (4%), stomatitis (2.4%), and pneumonia (1.6%). Fatal adverse reactions occurred in 1.6% of patients who received DATROWAY, due to death not otherwise specified.

Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 8% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >1% of patients included ILD/pneumonitis (2.4%) and abnormal hepatic function (1.6%).

Dosage interruptions of DATROWAY due to an adverse reaction occurred in 43% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (13%), stomatitis (7%), fatigue (6%), pneumonia (4%), anemia (2.4%), amylase increased (2.4%), keratitis (2.4%), ILD/pneumonitis (1.6%), decreased appetite (1.6%), dyspnea (1.6%), rash (1.6%), and infusion-related reaction (1.6%).

Dose reductions of DATROWAY due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (14%), keratitis (1.6%), fatigue (1.6%), decreased weight (1.6%) and COVID-19 (1.6%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis (71%), nausea (50%), alopecia (49%), fatigue (42%), decreased hemoglobin (34%), decreased lymphocytes (32%), constipation (31%), increased calcium (31%), increased AST (28%), decreased white blood cell count (27%), increased lactate dehydrogenase (23%), musculoskeletal pain (22%), decreased appetite (20%), increased ALT (20%), and rash (20%).

Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included dry skin, blurred vision, abdominal pain, conjunctivitis, dry mouth, ILD/pneumonitis, skin hyperpigmentation, increased lacrimation, and visual impairment.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus.
Lactation: There are no data regarding the presence of datopotamab deruxtecan-dlnk or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with DATROWAY and for 1 month after the last dose.
Females and Males of Reproductive Potential: Pregnancy Testing: Verify pregnancy status of females of reproductive potential prior to initiation of DATROWAY. Contraception: Females: Advise females of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Males: Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose. Infertility: Based on findings in animal toxicity studies, DATROWAY may impair male and female reproductive function and fertility. The effects on reproductive organs in animals were irreversible.
Pediatric Use: Safety and effectiveness of DATROWAY have not been established in pediatric patients.
Geriatric Use: Of the 125 patients with EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01 treated with DATROWAY 6 mg/kg, 44% were ≥65 years of age and 10% were ≥75 years of age. No clinically meaningful differences in efficacy and safety were observed between patients ≥65 years of age versus younger patients.
Renal Impairment: A higher incidence of ILD/pneumonitis has been observed in patients with mild and moderate renal impairment (creatinine clearance [CLcr] 30 to <90 mL/min). Monitor patients with renal impairment for increased adverse reactions, including respiratory reactions. No dosage adjustment is recommended in patients with mild to moderate renal impairment. The effect of severe renal impairment (CLcr <30 mL/min) on the pharmacokinetics of datopotamab deruxtecan-dlnk or DXd is unknown.
Hepatic Impairment: No dosage adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST). Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST). Monitor patients with moderate hepatic impairment for increased adverse reactions. The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

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 click here for full Prescribing Information, including WARNINGS AND PRECAUTIONS, and click here for Medication Guide.

2L+=second-line or later; ADC=antibody-drug conjugate; BICR=blinded independent central review; CDK=cyclin-dependent kinase; DCR=disease control rate; DoR=duration of response; ECOG=Eastern Cooperative Oncology Group; ET=endocrine therapy; HER2−=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; IHC=immunohistochemistry; ISH=in situ hybridization; IV=intravenous; mBC=metastatic breast cancer; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PS=performance status; Q3W=once every three weeks; Trop-2=trophoblast cell-surface antigen 2.

ADC=antibody-drug conjugate; BICR=blinded independent central review; CDK=cyclin-dependent kinase; Cl=confidence interval; CR=complete response; DCR=disease control rate; DoR=duration of response; ECOG=Eastern Cooperative Oncology Group; ET=endocrine therapy; HER2−=human epidermal growth factor receptor 2-negative; HR=hazard ratio; HR+=hormone receptor-positive; mBC=metastatic breast cancer; mOS=median overall survival; mPFS=median progression-free survival; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumours; SD=stable disease.

ADC=antibody-drug conjugate; HER2−=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; IHC=immunohistochemistry; ISH=in situ hybridization; IV=intravenous; Q3W=once every three weeks; Trop-2=trophoblast cell-surface antigen 2.

DNA=deoxyribonucleic acid; HER2−=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; mAb=monoclonal antibody; Trop-2=trophoblast cell-surface antigen 2.

HER2−=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive.

INDICATION

CONTRAINDICATIONS

None.

Common adverse reactions in the pooled locally advanced or metastatic EGFRm NSCLC population1*

The majority of adverse reactions were Grade 1 or 2 with DATROWAY*

24%

8%

Laboratory abnormalities in the pooled locally advanced or metastatic EGFRm NSCLC population1*

The majority of laboratory abnormalities were Grade 1 or 2

Select laboratory abnormalities (≥20%) that worsened from baseline in patients who received DATROWAY across three clinical trials*

Select adverse reactions in the pooled locally advanced or metastatic EGFRm NSCLC population1,3*

In the EGFRm NSCLC pooled patient population, adverse reactions of interest were mostly Grade 1 or 2

NOW APPROVED for locally advanced or metastatic EGFRm NSCLC

Common adverse reactions in the pooled locally advanced or metastatic EGFRm NSCLC population¹*

Laboratory abnormalities in the pooled locally advanced or metastatic EGFRm NSCLC population¹*

Select adverse reactions in the pooled locally advanced or metastatic EGFRm NSCLC population^1,3*