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[Dear]
[Hello]
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[Dr. Last Name],
[First Name],
[First Name Last Name],
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[Customize the text here with your own message to the healthcare provider in alignment with the Field Direction Memo (FDM). You may only send a 200-character message in alignment with the FDM. The message must be limited to a greeting and may not contain any implied/expressed product claims.]
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The NCCN Guidelines® recommend pralsetinib (GAVRETO) as a Category 2A:
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preferred first-line treatment for RET fusion-positive metastatic NSCLC1*
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systemic treatment option for structurally persistent/recurrent locoregional or distant metastatic RET fusion-positive PTC not amenable to RAI therapy2
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See the NCCN Guidelines for detailed recommendations, including other preferred treatment options.1
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NCCN makes no warranties of any kind whatsoever regarding their content use or application and
disclaims any responsibility for their application or use in any way.
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mNSCLC=metastatic non–small cell lung cancer; NCCN=National Comprehensive Cancer Network®
(NCCN® ); PTC=papillary thyroid cancer; RAI=radioactive iodine; RET=rearranged during transfection.
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GAVRETO is the only once-daily targeted RET therapy indicated for3:
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Adult patients with RET fusion+ mNSCLC as detected by an FDA-approved test
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Patients 12 years of age and older with advanced or metastatic RET fusion+ thyroid cancer who require systemic therapy and are RAI
refractory (if RAI is appropriate)†
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This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for
this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
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Select safety information
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Serious and sometimes fatal adverse reactions occurred with GAVRETO. Warnings and precautions include interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, tumor lysis syndrome, risk of impaired wound healing, and embryo-fetal toxicity.
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Please see additional Important Safety Information below and full Prescribing Information.
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Explore the NCCN Guidelines and their recommendations for testing and treating RET in:
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I’m including some additional information that you may find useful.
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I would be happy to set up a quick
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Select safety information
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Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and
fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including
3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly
investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce
dose or permanently discontinue GAVRETO based on severity of confirmed ILD.
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Hypertension: Occurred in 35% of patients, including Grade 3 hypertension
in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was
most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood
pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive
therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.
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Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST)
occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days
(range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated.
Withhold, reduce dose or permanently discontinue GAVRETO based on severity.
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Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with
GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.
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Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients
with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor
burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.
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Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor
(VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days 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 GAVRETO after resolution of wound healing complications has not been established.
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Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO 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 to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last
dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.
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Common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough.
Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate
aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin.
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Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate
CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or
moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.
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Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.
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Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.
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You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
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Please click here to see the full Prescribing Information and Patient Information for GAVRETO.
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