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Recap: Why consider GAVRETO (pralsetinib) for your patients? |
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Do you have questions about GAVRETO (pralsetinib)? |
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Thank you for meeting with me to talk about GAVRETO (pralsetinib) |
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Following up on our conversation about GAVRETO (pralsetinib) |
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Thank you for your time discussing GAVRETO (pralsetinib) |
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Here’s a quick summary based on our discussion |
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[From: <Rep Name> (REPNAME@blueprintmedicines.com)]
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[To: <Last Name, First Name>]
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[pick list]
[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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I wanted to follow up our conversation by sharing important information about GAVRETO® (pralsetinib), an approved targeted therapy for:
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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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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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Please see Important Safety Information below, and full Prescribing Information.
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mNSCLC=metastatic non–small cell lung cancer; RAI=radioactive iodine; RET=rearranged during transfection.
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The only once-daily RET inhibitor1
Pralsetinib targets RET in mNSCLC and advanced or metastatic thyroid cancer.1
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NCCN-RECOMMENDED TREATMENT OPTION
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend pralsetinib (GAVRETO) as a Category 2A:
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preferred first-line treatment for RET fusion-positive metastatic NSCLC2†
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systemic treatment option for structurally persistent/recurrent locoregional or distant metastatic RET fusion-positive PTC not amenable to RAI therapy3
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NCCN Guidelines® Recommend Testing in Eligible Patients with NSCLC or Advanced Thyroid Cancer:
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Molecular testing for certain biomarkers, including RET, in eligible patients with metastatic NSCLC2‡
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Genomic testing to identify actionable mutations, including RET, for structurally persistent/recurrent locally advanced or metastatic PTC not amenable to RAI therapy3
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See the NCCN Guidelines for detailed recommendations, including other preferred treatment options.2 |
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The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories. |
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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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NCCN=National Comprehensive Cancer Network® (NCCN®); PTC=papillary thyroid cancer.
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ARROW STUDY
Efficacy and safety with GAVRETO (400 mg orally once daily) were evaluated in patients with RET fusion+ mNSCLC and advanced or
metastatic RET fusion+ thyroid cancer in the ARROW study, a phase 1/2, nonrandomized, open-label, single-arm, multicohort,
multicenter clinical trial. All patients must have had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
The major efficacy outcome measures were overall response rate (ORR) and duration of response (DoR), as
assessed by a blinded independent central review (BICR) according to RECIST v1.1.1,4
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RECIST=Response Evaluation Criteria in Solid Tumors. |
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SEE THE RESULTS
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RET+ mNSCLC
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RET+ advanced thyroid cancer
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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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Please see Important Safety Information below and
full Prescribing Information.
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Assistance Options for Your Eligible Patients
Genentech Access Solutions provides helpful access and reimbursement support to assist your patients and practice after GAVRETO is prescribed.
For more information, visit genentech-access.com/GAVRETO
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References: 1. GAVRETO Prescribing Information. Genentech, Inc. August 2023.
2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network,
Inc. 2023. All rights reserved. Accessed August 19, 2023. To view the most recent and complete
version of the guideline, go to NCCN.org.
3. Referenced with permission from the NCCN Clinical
Practice Guidelines in Oncology (NCCN Guidelines®) for Thyroid Carcinoma V.4.2023. © National
Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed August 19, 2023. To view
the most recent and complete version of the guideline, go to NCCN.org.
4. Phase 1/2 study of the highly-selective RET inhibitor, pralsetinib (BLU-667), in participants with thyroid
cancer, non-small cell lung cancer, and other advanced solid tumors (ARROW). https://clinicaltrials.gov/ct2/show/NCT03037385. Accessed August 19, 2023.
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I’m including some additional information that you may find useful.
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GAVRETO RET+ mNSCLC and Advanced Thyroid Cancer Product Brochure
An overview of GAVRETO for the treatment of patients with RET+ mNSCLC or advanced thyroid cancer.
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Oncology Prescriber Service Form
This form includes patient, insurance, and prescription information and is used when Genentech Access Solutions contacts a patient’s health insurance plan to determine his or her coverage.
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GAVRETO Access & Reimbursement Guide
Includes information on product ordering, patient support, navigating the approval process, managing denials and appeals, and coverage information for diagnostic tests and related coding.
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I’m available in person or virtually to answer any questions you may have.
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[Sincerely],
[Best],
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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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