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Sharing GAVRETO (pralsetinib) efficacy and safety data |
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GAVRETO (pralsetinib): Have you seen the data? |
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Are you available to speak with me about an approved RET inhibitor? |
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Explore the efficacy and safety data for an approved RET inhibitor for RET+ thyroid cancers |
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Thank you for your time discussing GAVRETO (pralsetinib) |
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Efficacy and safety data from the clinical trial enclosed |
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[From: <Rep Name> (REPNAME@blueprintmedicines.com)]
[Sent: <MM/DD/YYYY HH:MM AM/PM>]
[To: <Last Name, First Name>]
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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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GAVRETO is indicated for the treatment of adult and pediatric 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).1
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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 trials.
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Please see Important Safety Information below and full Prescribing Information.
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RAI=radioactive iodine; RET=rearranged during transfection.
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ARROW study design
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Efficacy and safety with GAVRETO (400 mg once daily) was evaluated in patients with 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 0-1.1,2
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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
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RECIST=Response Evaluation Criteria in Solid Tumors.
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Efficacy and safety results in advanced or metastatic RET fusion+ thyroid cancer1
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Overall Response Rate (n=9)
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PR: 89%
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Median DoR (95% CI) (n=8): NR (NE-NE)
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100% of patients continued to respond to treatment at 6 months* |
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Median time to first response was 1.9 months (range: 1.8-5.5 months)3 |
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*Based on an observed DoR.
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CI=confidence interval; NE=not estimable; NR=not reached; PR=partial response.
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Adverse reactions in RET-altered thyroid cancer patients taking GAVRETO (n=138)1*
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Serious adverse reactions occurred in 39% of patients who received GAVRETO. The most frequent serious adverse reactions (in ≥2% of
patients) were pneumonia, pneumonitis, urinary tract infection, pyrexia, fatigue, diarrhea, dizziness, anemia, hyponatremia, and ascites. Fatal
adverse reactions occurred in 2.2% of patients; fatal adverse reactions that occurred in >1 patient included pneumonia (n=2).
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Adverse reactions (≥15%) were musculoskeletal pain (42%), constipation (41%), hypertension (40%), fatigue (38%), diarrhea (34%), edema
(29%), cough (27%), headache (24%), rash (24%), dyspnea (22%), pyrexia (22%), peripheral neuropathy (20%), dizziness (19%), abdominal
pain (17%), dry mouth (17%), dysgeusia (17%), nausea (17%), stomatitis (17%), and decreased appetite (15%).
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*Includes 19 patients with RET fusion-positive thyroid cancer.
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mNSCLC=metastatic non-small cell lung cancer.
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I've included some additional resources you may find useful:
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[Fragment/attachment pick list]
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Oncology Prescriber Service Form
The Oncology Prescriber Service 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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Genentech Co-Pay Assistance Program
Genentech co-pay programs provide financial assistance to eligible commercially insured patients to help with their co-pays, co-insurance, or other out-of-pocket (OOP) costs. To find out if your patients qualify or to get more information about the Genentech Co-pay Assistance Program, call (855) MYCOPAY (692-6729) or visit copayassistancenow.com
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[pick list]
[Sincerely],
[Best],
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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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References: 1. GAVRETO Prescribing Information. Genentech, Inc. August 2023.
2. Phase 1/2 study of the highly-selective RET inhibitor, pralsetinib (BLU-667), in
patients with thyroid cancer, non-small cell lung cancer, and other advanced solid tumors (ARROW).
ClinicalTrials.gov identifier: NCT03037385. Accessed August 14, 2023.
3. Data on file. Blueprint Medicines Corporation. Cambridge, MA; 2020.
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