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.
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Our speakers will be:
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Adam Burgoyne, MD, PhD
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UC San Diego Moores Cancer Center San Diego, CA
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Thursday, October 15th, 2020 12:00 PM EST | 9:00 AM PST
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Sandra Brackert, NP-C
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UCLA Marina Del Ray, CA
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Tuesday, October 20th, 2020 11:00 AM EST | 8:00 AM PST
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Please see the complete Important Safety Information below and the full US Prescribing Information.
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During this program, we will focus on the following:
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1.
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Educating on advancements and unmet needs in the treatment of GIST
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2.
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Presenting approval of QINLOCK in 4L GIST based on the outcome of the INVICTUS study
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3.
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Describing the efficacy and safety of QINLOCK from INVICTUS
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4.
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Describing patient management for QINLOCK
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5.
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Increasing understanding of how to manage select adverse reactions during treatment
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6.
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Highlighting important safety information for QINLOCK
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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.
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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.
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Please see Important Safety Information below and US Full Prescribing Information.
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www.deciphera.com
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INDICATIONS AND USAGE
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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.
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IMPORTANT SAFETY INFORMATION
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There are no contraindications for QINLOCK.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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The safety and effectiveness of QINLOCK in pediatric patients have not been established.
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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.
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Please see accompanying full Prescribing Information, including Patient Information.
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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.
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© 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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