How was PADCEV® shown to help some people?

PADCEV was studied in 2 different groups of people with advanced bladder cancer or cancers of the urinary tract:

Study 1: Adults who had previously received an immunotherapy medicine and platinum-containing chemotherapy.

Adults who had previously received an immunotherapy medicine and platinum-containing chemotherapy

Study 2: Adults who could not receive cisplatin, but who had previously received an immunotherapy medicine.

Adults who could not receive cisplatin, but who had previously received an immunotherapy medicine

Study 1
Study 2

Previously received immunotherapy + could not receive cisplatin

Study 2 included 89 adults with advanced bladder cancer or cancers of the urinary tract. To participate in this study, these adults must have:

Previously received an immunotherapy

Never received a platinum-containing chemotherapy

Been unable to receive a treatment called cisplatin

Unlike the design of Study 1, the results of people receiving PADCEV in this study were not compared to a control group.

During the study, those who could not receive cisplatin and had previously received immunotherapy:

51% of adults had their tumors shrink or had no detectable tumors.
28% of adults had their tumors shrink. 22% of adults had no detectable tumors.

Due to rounding of complete response and partial response, percentages may not add up to the separately rounded objective response rate.

*Half of the adults were followed for about 13 months or longer, and the other half were followed for less than 13 months.

Of those who responded to PADCEV:

More than half responded for more than 13 months: More than half did not have their tumors grow or spread for over a year.

more than half did not have their tumors grow or spread for over a year

Glossary definitions icon.

Objective response rate: The percentage of people whose cancer shrinks or is not detectable after treatment for a minimum time period

Partial response: When the tumors shrink. In the PADCEV trial, a decrease in the size of a tumor by 30% was considered a partial response

Complete response: When a treatment gets rid of all tumors that could be measured or seen on a test

Previously received immunotherapy + platinum-containing chemotherapy

Study 1 included 608 adults with advanced bladder cancer who had previously received an immunotherapy medicine and platinum-containing chemotherapy.

Study 1 compared the results of people who received PADCEV with people who received chemotherapy during the study.

During the study, more people who received PADCEV lived longer compared to people who received chemotherapy

PADCEV improved median overall survival. 13 month median overall survival with PADCEV vs 9 months with chemotherapy.

During the study, more than twice as many people saw their tumors shrink or become undetectable with PADCEV (Overall Response Rate) vs chemotherapy*

41% objective response rate with PADCEV. 18% objective response rate with chemotherapy.
41% objective response rate with PADCEV.
18% objective response rate with chemotherapy.

*95% confidence interval: 34.9%, 46.5% with PADCEV and 13.7%, 22.8% with chemotherapy.

Glossary definitions icon.

Median overall survival: The length of time from the start of treatment in the study that half of the people in each group were still alive

Overall response rate: The percentage of people whose cancer shrinks or is not detectable after treatment for a minimum time period



IMPORTANT SAFETY INFORMATION

What is the most important
information I should know about PADCEV?

PADCEV may cause serious side effects, including:

Skin reactions. Severe skin reactions have happened in people treated with PADCEV; in some cases severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle (28 days) of treatment but may happen later. Your healthcare provider will monitor you during treatment and may prescribe medicines if you get skin reactions. Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction:

target lesions (skin reactions that look like rings)

rash or itching that continues to get worse

blistering or peeling of the skin

painful sores or ulcers in mouth or nose, throat, or genital area

fever or flu-like symptoms

swollen lymph nodes

See “What are the possible side effects of PADCEV?” for more information about side effects.

PADCEV Important Safety Information icon

Before receiving PADCEV, tell your healthcare provider about all of your medical conditions, including if you:

are currently experiencing numbness or tingling in your hands or feet

have a history of high blood sugar or diabetes

have liver problems

are pregnant or plan to become pregnant. PADCEV can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with PADCEV

are breastfeeding or plan to breastfeed. It is not known if PADCEV passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of PADCEV

Pregnancy warning for females icon

Females who are able to become
pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with PADCEV.

You should use an effective method of birth control during your treatment and for at least 2 months after the last dose of PADCEV.

Pregnancy warning for males icon

Males with a female sexual partner
who is able to become pregnant:

If your female partner is pregnant, PADCEV can harm the unborn baby.

You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of PADCEV.

Drug interactions icon

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking PADCEV with certain other medicines may cause side effects.

Infusion icon

How will I receive PADCEV?

PADCEV will be given to you by intravenous (IV) infusion into your vein over 30 minutes.

You will receive your PADCEV over periods of time called cycles.

- Each PADCEV cycle is 28 days.

- You will receive PADCEV on days 1, 8 and 15 of every cycle.

Your healthcare provider will decide how many treatment cycles you need.

Your healthcare provider may do blood tests regularly during treatment with PADCEV.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects including:

Skin reactions icon

Skin Reactions. See “Skin Reactions” above for more information.

High blood sugar icon

High Blood Sugar (hyperglycemia). You can develop high blood sugar during treatment with PADCEV. High blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes who were treated with PADCEV. Tell your healthcare provider right away if you have any symptoms of high blood sugar, including: frequent urination, increased thirst, blurred vision, confusion, it becomes harder to control your blood sugar, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting, or stomach pain.

Lung problems icon

Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Hand with peripheral neuropathy icon

Peripheral neuropathy. You may develop nerve problems called peripheral neuropathy during treatment with PADCEV. Tell your healthcare provider right away if you get new or worsening numbness or tingling in your hands or feet, or muscle weakness.

Eye problems icon

Eye problems. You can develop certain eye problems during treatment with PADCEV. Tell your healthcare provider right away if you have dry eyes, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.

Infusion site extravasation icon

Leakage of PADCEV out of your vein into the tissues around your infusion site (extravasation). If PADCEV leaks from the injection site or the vein into the nearby skin and tissues, it could cause an infusion site reaction. These reactions can happen right after you receive an infusion, but sometimes may happen days after your infusion. Tell your healthcare provider or get medical help right away if you notice any redness, swelling, itching, or discomfort at the infusion site.

The most common side effects of PADCEV
include:

skin rash

changes in liver and kidney function tests

increased sugar (glucose) in the blood

tiredness

numbness or tingling in your hands or feet, or muscle weakness

decreased white blood cell, red blood cell, and platelet counts

hair loss

decreased appetite

diarrhea

decreased sodium, phosphate and protein (albumin) in the blood

nausea

itching

change in sense of taste

increased uric acid in the blood

increased lipase (a blood test done to check your pancreas)

decreased weight

dry skin

If you have certain side effects, your healthcare provider may decrease your dose or stop your treatment with PADCEV for a period of time (temporarily) or completely.

PADCEV may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of PADCEV.

Communicate with your doctor icon

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.



WHAT IS PADCEV®?

PADCEV is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you:

have received an immunotherapy medicine and chemotherapy that contains platinum, or

you are not able to receive a chemotherapy that contains the medicine cisplatin and you have received one or more prior therapy.

It is not known if PADCEV is safe and effective in children.

Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.



IMPORTANT SAFETY INFORMATION

What is the most important
information I should know about PADCEV?

PADCEV may cause serious side effects, including:

Skin reactions. Severe skin reactions have happened in people treated with PADCEV; in some cases severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle (28 days) of treatment but may happen later. Your healthcare provider will monitor you during treatment and may prescribe medicines if you get skin reactions. Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction:

target lesions (skin reactions that look like rings)

rash or itching that continues to get worse

blistering or peeling of the skin

painful sores or ulcers in mouth or nose, throat, or genital area

fever or flu-like symptoms

swollen lymph nodes

See “What are the possible side effects of PADCEV?” for more information about side effects.

PADCEV Important Safety Information icon

Before receiving PADCEV, tell your healthcare provider about all of your medical conditions, including if you:

are currently experiencing numbness or tingling in your hands or feet

have a history of high blood sugar or diabetes

have liver problems

are pregnant or plan to become pregnant. PADCEV can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with PADCEV

are breastfeeding or plan to breastfeed. It is not known if PADCEV passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of PADCEV

Pregnancy warning for females icon

Females who are able to become
pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with PADCEV.

You should use an effective method of birth control during your treatment and for at least 2 months after the last dose of PADCEV.

Pregnancy warning for males icon

Males with a female sexual partner
who is able to become pregnant:

If your female partner is pregnant, PADCEV can harm the unborn baby.

You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of PADCEV.

Drug interactions icon

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking PADCEV with certain other medicines may cause side effects.

Infusion icon

How will I receive PADCEV?

PADCEV will be given to you by intravenous (IV) infusion into your vein over 30 minutes.

You will receive your PADCEV over periods of time called cycles.

- Each PADCEV cycle is 28 days.

- You will receive PADCEV on days 1, 8 and 15 of every cycle.

Your healthcare provider will decide how many treatment cycles you need.

Your healthcare provider may do blood tests regularly during treatment with PADCEV.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects including:

Skin reactions icon

Skin Reactions. See “Skin Reactions” above for more information.

High blood sugar icon

High Blood Sugar (hyperglycemia). You can develop high blood sugar during treatment with PADCEV. High blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes who were treated with PADCEV. Tell your healthcare provider right away if you have any symptoms of high blood sugar, including: frequent urination, increased thirst, blurred vision, confusion, it becomes harder to control your blood sugar, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting, or stomach pain.

Lung problems icon

Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Hand with peripheral neuropathy icon

Peripheral neuropathy. You may develop nerve problems called peripheral neuropathy during treatment with PADCEV. Tell your healthcare provider right away if you get new or worsening numbness or tingling in your hands or feet, or muscle weakness.

Eye problems icon

Eye problems. You can develop certain eye problems during treatment with PADCEV. Tell your healthcare provider right away if you have dry eyes, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.

Infusion site extravasation icon

Leakage of PADCEV out of your vein into the tissues around your infusion site (extravasation). If PADCEV leaks from the injection site or the vein into the nearby skin and tissues, it could cause an infusion site reaction. These reactions can happen right after you receive an infusion, but sometimes may happen days after your infusion. Tell your healthcare provider or get medical help right away if you notice any redness, swelling, itching, or discomfort at the infusion site.

The most common side effects of PADCEV
include:

skin rash

changes in liver and kidney function tests

increased sugar (glucose) in the blood

tiredness

numbness or tingling in your hands or feet, or muscle weakness

decreased white blood cell, red blood cell, and platelet counts

hair loss

decreased appetite

diarrhea

decreased sodium, phosphate and protein (albumin) in the blood

nausea

itching

change in sense of taste

increased uric acid in the blood

increased lipase (a blood test done to check your pancreas)

decreased weight

dry skin

If you have certain side effects, your healthcare provider may decrease your dose or stop your treatment with PADCEV for a period of time (temporarily) or completely.

PADCEV may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of PADCEV.

Communicate with your doctor icon

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.



WHAT IS PADCEV®?

PADCEV is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you:

have received an immunotherapy medicine and chemotherapy that contains platinum, or

you are not able to receive a chemotherapy that contains the medicine cisplatin and you have received one or more prior therapy.

It is not known if PADCEV is safe and effective in children.

Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.



IMPORTANT SAFETY INFORMATION

What is the most important
information I should know about PADCEV?

PADCEV may cause serious side effects, including:

Skin reactions. Severe skin reactions have happened in people treated with PADCEV; in some cases severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle (28 days) of treatment but may happen later. Your healthcare provider will monitor you during treatment and may prescribe medicines if you get skin reactions. Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction:

target lesions (skin reactions that look like rings)

rash or itching that continues to get worse

blistering or peeling of the skin

painful sores or ulcers in mouth or nose, throat, or genital area

fever or flu-like symptoms

swollen lymph nodes

See “What are the possible side effects of PADCEV?” for more information about side effects.

PADCEV Important Safety Information icon

Before receiving PADCEV, tell your healthcare provider about all of your medical conditions, including if you:

are currently experiencing numbness or tingling in your hands or feet

have a history of high blood sugar or diabetes

have liver problems

are pregnant or plan to become pregnant. PADCEV can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with PADCEV

are breastfeeding or plan to breastfeed. It is not known if PADCEV passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of PADCEV

Pregnancy warning for females icon

Females who are able to become
pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with PADCEV.

You should use an effective method of birth control during your treatment and for at least 2 months after the last dose of PADCEV.

Pregnancy warning for males icon

Males with a female sexual partner
who is able to become pregnant:

If your female partner is pregnant, PADCEV can harm the unborn baby.

You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of PADCEV.

Drug interactions icon

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking PADCEV with certain other medicines may cause side effects.

Infusion icon

How will I receive PADCEV?

PADCEV will be given to you by intravenous (IV) infusion into your vein over 30 minutes.

You will receive your PADCEV over periods of time called cycles.

- Each PADCEV cycle is 28 days.

- You will receive PADCEV on days 1, 8 and 15 of every cycle.

Your healthcare provider will decide how many treatment cycles you need.

Your healthcare provider may do blood tests regularly during treatment with PADCEV.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects including:

Skin reactions icon

Skin Reactions. See “Skin Reactions” above for more information.

High blood sugar icon

High Blood Sugar (hyperglycemia). You can develop high blood sugar during treatment with PADCEV. High blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes who were treated with PADCEV. Tell your healthcare provider right away if you have any symptoms of high blood sugar, including: frequent urination, increased thirst, blurred vision, confusion, it becomes harder to control your blood sugar, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting, or stomach pain.

Lung problems icon

Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Hand with peripheral neuropathy icon

Peripheral neuropathy. You may develop nerve problems called peripheral neuropathy during treatment with PADCEV. Tell your healthcare provider right away if you get new or worsening numbness or tingling in your hands or feet, or muscle weakness.

Eye problems icon

Eye problems. You can develop certain eye problems during treatment with PADCEV. Tell your healthcare provider right away if you have dry eyes, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.

Infusion site extravasation icon

Leakage of PADCEV out of your vein into the tissues around your infusion site (extravasation). If PADCEV leaks from the injection site or the vein into the nearby skin and tissues, it could cause an infusion site reaction. These reactions can happen right after you receive an infusion, but sometimes may happen days after your infusion. Tell your healthcare provider or get medical help right away if you notice any redness, swelling, itching, or discomfort at the infusion site.

The most common side effects of PADCEV
include:

skin rash

changes in liver and kidney function tests

increased sugar (glucose) in the blood

tiredness

numbness or tingling in your hands or feet, or muscle weakness

decreased white blood cell, red blood cell, and platelet counts

hair loss

decreased appetite

diarrhea

decreased sodium, phosphate and protein (albumin) in the blood

nausea

itching

change in sense of taste

increased uric acid in the blood

increased lipase (a blood test done to check your pancreas)

decreased weight

dry skin

If you have certain side effects, your healthcare provider may decrease your dose or stop your treatment with PADCEV for a period of time (temporarily) or completely.

PADCEV may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of PADCEV.

Communicate with your doctor icon

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.



WHAT IS PADCEV®?

PADCEV is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you:

have received an immunotherapy medicine and chemotherapy that contains platinum, or

you are not able to receive a chemotherapy that contains the medicine cisplatin and you have received one or more prior therapy.

It is not known if PADCEV is safe and effective in children.

Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.

© 2021 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. 081-0364-PM 07/21
PADCEV® and the PADCEV device are trademarks jointly owned by Agensys, Inc. and Seagen, Inc.
Astellas and the flying star logo are registered trademarks of Astellas Pharma Inc.
Seagen and the Seagen logo are registered trademarks of Seagen Inc.
PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, is a service mark of Astellas Pharma US, Inc.


© 2021 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. 081-0364-PM 07/21
PADCEV® and the PADCEV device are trademarks jointly owned by Agensys, Inc. and Seagen, Inc.
Astellas and the flying star logo are registered trademarks of Astellas Pharma Inc.
Seagen and the Seagen logo are registered trademarks of Seagen Inc.
PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, is a service mark of Astellas Pharma US, Inc.

© 2021 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. 081-0364-PM 07/21
PADCEV® and the PADCEV device are trademarks jointly owned by Agensys, Inc. and Seagen, Inc.
Astellas and the flying star logo are registered trademarks of Astellas Pharma Inc.
Seagen and the Seagen logo are registered trademarks of Seagen Inc.
PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, is a service mark of Astellas Pharma US, Inc.


© 2021 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. 081-0364-PM 07/21
PADCEV® and the PADCEV device are trademarks jointly owned by Agensys, Inc. and Seagen, Inc.
Astellas and the flying star logo are registered trademarks of Astellas Pharma Inc.
Seagen and the Seagen logo are registered trademarks of Seagen Inc.
PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, is a service mark of Astellas Pharma US, Inc.