Details
 

October 15-20, 2020

QINLOCK™ (ripretinib) for the Treatment of Eligible Patients with Advanced GIST

Hosted by Deciphera

A Virtual Event - Multiple Broadcast Times

 

We are pleased to invite you to an educational webinar on QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. 

Click here to register. 

Our speakers will be:

Adam Burgoyne, MD, PhD

UC San Diego Moores Cancer Center 
San Diego, CA


Thursday, October 15th, 2020
12:00 PM EST | 9:00 AM PST

 

Sandra Brackert, NP-C

UCLA
Marina Del Ray, CA


Tuesday, October 20th, 2020
11:00 AM EST | 8:00 AM PST

 

Please see the complete Important Safety Information below and the full US Prescribing Information.

During this program, we will focus on the following:

 

1.

Educating on advancements and unmet needs in the treatment of GIST

2.

Presenting approval of QINLOCK in 4L GIST based on the outcome of the INVICTUS study

3.

Describing the efficacy and safety of QINLOCK from INVICTUS

4.

Describing patient management for QINLOCK

5.

Increasing understanding of how to manage select adverse reactions during treatment

6.

Highlighting important safety information for QINLOCK

If you’d like to register for this program, please use the above button, which will direct you to the platform to sign up or enter the URL:
https://portal.xyvid.com/group/QINLOCKgroupwebinars

Please reach out to kdiehl@pharmethod.com with any questions.

The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase and decreased phosphate.

Please see Important Safety Information below and US Full Prescribing Information.

www.deciphera.com

INDICATIONS AND USAGE

QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

IMPORTANT SAFETY INFORMATION

There are no contraindications for QINLOCK.

Palmar-plantar erythrodysesthesia syndrome (PPES): In INVICTUS, Grade 1-2 PPES occurred in 21% of the 85 patients who received QINLOCK. PPES led to dose discontinuation in 1.2% of patients, dose interruption in 2.4% of patients, and dose reduction in 1.2% of patients. Based on severity, withhold QINLOCK and then resume at same or reduced dose.

New Primary Cutaneous Malignancies: In INVICTUS, cutaneous squamous cell carcinoma (cuSCC) occurred in 4.7% of the 85 patients who received QINLOCK with a median time to event of 4.6 months (range 3.8 to 6 months). In the pooled safety population, cuSCC and keratoacanthoma occurred in 7% and 1.9% of 351 patients, respectively. In INVICTUS, melanoma occurred in 2.4% of the 85 patients who received QINLOCK. In the pooled safety population, melanoma occurred in 0.9% of 351 patients. Perform dermatologic evaluations when initiating QINLOCK and routinely during treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Continue QINLOCK at the same dose.

Hypertension: In INVICTUS, Grade 1-3 hypertension occurred in 14% of the 85 patients who received QINLOCK, including Grade 3 hypertension in 7% of patients. Do not initiate QINLOCK in patients with uncontrolled hypertension. Monitor blood pressure as clinically indicated. Based on severity, withhold QINLOCK and then resume at same or reduced dose or permanently discontinue.

Cardiac Dysfunction: In INVICTUS, cardiac failure occurred in 1.2% of the 85 patients who received QINLOCK. In the pooled safety population, cardiac dysfunction (including cardiac failure, acute left ventricular failure, diastolic dysfunction, and ventricular hypertrophy) occurred in 1.7% of 351 patients, including Grade 3 adverse events in 1.1% of patients.

In INVICTUS, Grade 3 decreased ejection fraction occurred in 2.6% of the 77 patients who received QINLOCK and who had a baseline and at least one post-baseline echocardiogram. Grade 3 decreased ejection fraction occurred in 3.4% of the 263 patients in the pooled safety population who received QINLOCK and who had a baseline and at least one post-baseline echocardiogram.

In INVICTUS, cardiac dysfunction led to dose discontinuation in 1.2% of the 85 patients who received QINLOCK. The safety of QINLOCK has not been assessed in patients with a baseline ejection fraction below 50%. Assess ejection fraction by echocardiogram or MUGA scan prior to initiating QINLOCK and during treatment, as clinically indicated. Permanently discontinue QINLOCK for Grade 3 or 4 left ventricular systolic dysfunction.

Risk of Impaired Wound Healing: QINLOCK has the potential to adversely affect wound healing. Withhold QINLOCK for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of QINLOCK after resolution of wound healing complications has not been established.

Embryo-Fetal Toxicity: QINLOCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 1 week after the final dose. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for at least 1 week after the final dose. QINLOCK may impair fertility in males of reproductive potential.

Adverse Reactions: The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, PPES, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase and decreased phosphate.

The safety and effectiveness of QINLOCK in pediatric patients have not been established.

Administer strong CYP3A inhibitors with caution. Monitor patients who are administered strong CYP3A inhibitors more frequently for adverse reactions. Avoid concomitant use with strong CYP3A inducers.

Please see accompanying full Prescribing Information, including Patient Information.

To report SUSPECTED ADVERSE REACTIONS, contact Deciphera Pharmaceuticals, LLC, at 1‑888‑724‑3274 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

© 2020 Deciphera Pharmaceuticals. Deciphera, Deciphera Pharmaceuticals, QINLOCK, the Deciphera logo, and the QINLOCK logo are trademarks of Deciphera Pharmaceuticals, LLC. All rights reserved. DCPH‑P00205

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2020-10-15 2020-10-20 America/Detroit QINLOCK™ (ripretinib) for the Treatment of Eligible Patients with Advanced GIST   We are pleased to invite you to an educational webinar on QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.  Click here to register.  Our speakers will be: Adam Burgoyne, MD, PhD UC San Diego Moores Cancer Center San Diego, CA Thursday, October 15th, 2020 12:00 PM EST | 9:00 AM PST   Sandra Brackert, NP-C UCLAMarina Del Ray, CA Tuesday, October 20th, 2020 11:00 AM EST | 8:00 AM PST   Please see the complete Important Safety Information below and the full US Prescribing Information. During this program, we will focus on the following:   1. Educating on advancements and unmet needs in the treatment of GIST 2. Presenting approval of QINLOCK in 4L GIST based on the outcome of the INVICTUS study 3. Describing the efficacy and safety of QINLOCK from INVICTUS 4. Describing patient management for QINLOCK 5. Increasing understanding of how to manage select adverse reactions during treatment 6. Highlighting important safety information for QINLOCK If you’d like to register for this program, please use the above button, which will direct you to the platform to sign up or enter the URL:https://portal.xyvid.com/group/QINLOCKgroupwebinars Please reach out to kdiehl@pharmethod.com with any questions. The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase and decreased phosphate. Please see Important Safety Information below and US Full Prescribing Information. www.deciphera.com INDICATIONS AND USAGE QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. IMPORTANT SAFETY INFORMATION There are no contraindications for QINLOCK. Palmar-plantar erythrodysesthesia syndrome (PPES): In INVICTUS, Grade 1-2 PPES occurred in 21% of the 85 patients who received QINLOCK. PPES led to dose discontinuation in 1.2% of patients, dose interruption in 2.4% of patients, and dose reduction in 1.2% of patients. Based on severity, withhold QINLOCK and then resume at same or reduced dose. New Primary Cutaneous Malignancies: In INVICTUS, cutaneous squamous cell carcinoma (cuSCC) occurred in 4.7% of the 85 patients who received QINLOCK with a median time to event of 4.6 months (range 3.8 to 6 months). In the pooled safety population, cuSCC and keratoacanthoma occurred in 7% and 1.9% of 351 patients, respectively. In INVICTUS, melanoma occurred in 2.4% of the 85 patients who received QINLOCK. In the pooled safety population, melanoma occurred in 0.9% of 351 patients. Perform dermatologic evaluations when initiating QINLOCK and routinely during treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Continue QINLOCK at the same dose. Hypertension: In INVICTUS, Grade 1-3 hypertension occurred in 14% of the 85 patients who received QINLOCK, including Grade 3 hypertension in 7% of patients. Do not initiate QINLOCK in patients with uncontrolled hypertension. Monitor blood pressure as clinically indicated. Based on severity, withhold QINLOCK and then resume at same or reduced dose or permanently discontinue. Cardiac Dysfunction: In INVICTUS, cardiac failure occurred in 1.2% of the 85 patients who received QINLOCK. In the pooled safety population, cardiac dysfunction (including cardiac failure, acute left ventricular failure, diastolic dysfunction, and ventricular hypertrophy) occurred in 1.7% of 351 patients, including Grade 3 adverse events in 1.1% of patients. In INVICTUS, Grade 3 decreased ejection fraction occurred in 2.6% of the 77 patients who received QINLOCK and who had a baseline and at least one post-baseline echocardiogram. Grade 3 decreased ejection fraction occurred in 3.4% of the 263 patients in the pooled safety population who received QINLOCK and who had a baseline and at least one post-baseline echocardiogram. In INVICTUS, cardiac dysfunction led to dose discontinuation in 1.2% of the 85 patients who received QINLOCK. The safety of QINLOCK has not been assessed in patients with a baseline ejection fraction below 50%. Assess ejection fraction by echocardiogram or MUGA scan prior to initiating QINLOCK and during treatment, as clinically indicated. Permanently discontinue QINLOCK for Grade 3 or 4 left ventricular systolic dysfunction. Risk of Impaired Wound Healing: QINLOCK has the potential to adversely affect wound healing. Withhold QINLOCK for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of QINLOCK after resolution of wound healing complications has not been established. Embryo-Fetal Toxicity: QINLOCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 1 week after the final dose. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for at least 1 week after the final dose. QINLOCK may impair fertility in males of reproductive potential. Adverse Reactions: The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, PPES, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase and decreased phosphate. The safety and effectiveness of QINLOCK in pediatric patients have not been established. Administer strong CYP3A inhibitors with caution. Monitor patients who are administered strong CYP3A inhibitors more frequently for adverse reactions. Avoid concomitant use with strong CYP3A inducers. Please see accompanying full Prescribing Information, including Patient Information. To report SUSPECTED ADVERSE REACTIONS, contact Deciphera Pharmaceuticals, LLC, at 1‑888‑724‑3274 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. © 2020 Deciphera Pharmaceuticals. Deciphera, Deciphera Pharmaceuticals, QINLOCK, the Deciphera logo, and the QINLOCK logo are trademarks of Deciphera Pharmaceuticals, LLC. All rights reserved. DCPH‑P00205 A Virtual Event - Multiple Broadcast Times