About RET+ mNSCLC

The importance of obtaining complete biomarker test results prior to initiating first-line therapy in mNSCLC

About 1 in 2

About 1 in 2 patients with mNSCLC have biomarkers with approved, emerging, or evolving therapeutics.2,4

RET fusions are 1 of 8 driver alterations with FDA-approved therapies2,4*

1 of 8 alterations

*Current as of May 2022.
Emerging Therapeutics=currently being studied in clinical trials; Evolving Therapeutics=either proof-of-concept studies or in a very early clinical stage. ALK=anaplastic lymphoma kinase; BRAF=B-Raf proto-oncogene; EGFR=endothelial growth factor receptor; ERBB2=receptor tyrosine kinase ErbB2 (human EGF receptor 2 or HER2); KRAS=Kirsten rat sarcoma; MET=MET proto-oncogene; mNSCLC=metastatic non–small cell lung cancer; NTRK=neurotrophic tyrosine receptor kinase; RET+=rearranged during transfection positive; ROS1=ROS proto-oncogene 1.

Talk to your pathologist or lab partners to determine how to best test comprehensively for all biomarkers in mNSCLC, including RET

Comprehensive biomarker testing can assess most actionable biomarkers with one test—so you can identify which biomarker may be responsible for driving disease5

The National Comprehensive Cancer Network® (NCCN®) NSCLC Panel recommends that eligible patients with metastatic NSCLC receive routine biomarker testing for2:

  • EGFR mutations
  • ALK fusions
  • ROS1 fusions
  • BRAF mutations
  • KRAS G12C mutations
  • METex14 skipping mutations
  • RET rearrangements
  • NTRK1/2/3 gene fusions
  • PD-L1 expression levels

Insufficient tissue (or QNS) is not a conclusive result and may lead to an uninformed treatment decision2

NGS-based tissue genotyping and plasma ctDNA testing are considered accurate, reliable, and complementary approaches to test for actionable biomarkers, including RET alterations.6

  • Testing of plasma ctDNA may overcome some of the limitations of tumor tissue genotyping due to faster turnaround time and a less invasive procedure6
  • Plasma ctDNA testing is recommended by both IASLC and NCCN under certain circumstances2,6

IASLC Guidelines6

Plasma ctDNA can now be considered a valid tool for genotyping of newly diagnosed patients with advanced NSCLC and should be performed using a clinically validated NGS platform

NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines®)2

NCCN Guidelines® recommend plasma ctDNA testing as an option when there is limited tissue availability or the patient is unfit for invasive tissue sampling

Checkmark shield

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.
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.
ctDNA=circulating tumor DNA; IASLC=International Association for the Study of Lung Cancer; NCCN=National Comprehensive Cancer Network® (NCCN®); NGS=next generation sequencing; PD-L1=programmed death-ligand 1; QNS=quality not sufficient.

Use biomarker test results to help guide treatment decisions in mNSCLC4,7,8

Reviewing biomarker test results before initiating treatment could help determine an appropriate treatment plan8

targeted therapy

Targeted therapies may lead to better outcomes in patients with actionable biomarkers8-11

  • Although many mNSCLC patients have derived benefit from immunotherapy (IO), some biomarker-driven cancers may respond poorly to IO treatment12-15
    • mNSCLC patients with biomarkers are often excluded from IO clinical trials13,16
    • In a retrospective study of 551 advanced NSCLC patients, IO response rates in select biomarker-driven NSCLC were12:
      • ALK (n=23): 0%
      • RET (n=16): 6%
      • EGFR (n=125): 12%
      • KRAS (n=271): 26%
      • BRAF (n=43): 24%
      • ROS1 (n=7): 17%
      • MET (n=36): 16%
NCCN Guidelines

Guidelines state that, for eligible patients with metastatic NSCLC who have actionable genetic variants, targeted therapy2:

  • is recommended as a first-line treatment option
  • has been shown to decrease tumor burden, decrease symptoms, and dramatically improve quality of life
  • for the oncogenic driver should take precedence over treatment with an immune checkpoint inhibitor, even when PD-L1 expression is elevated in patients with an oncogenic driver
RET fusion DNA

Select patients for treatment based on the presence of a RET gene fusion. Consider a selectively designed RET inhibitor1

Information on FDA-approved tests for RET gene fusions is available at http://www.fda.gov/CompanionDiagnostics

LEARN MORE

Important Safety Information & Indications

INDICATIONS

GAVRETO® (pralsetinib) is indicated for the treatment of:

  • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 10% of patients who received GAVRETO, including 2.7% with Grade 3/4, and 0.5% 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.

Hypertension occurred in 29% of patients, including Grade 3 hypertension in 14% of patients. Overall, 7% had their dose interrupted and 3.2% 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.

Hepatotoxicity: Serious hepatic adverse reactions occurred in 2.1% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 69% of patients, including Grade 3/4 in 5% and increased alanine aminotransferase (ALT) occurred in 46% of patients, including Grade 3/4 in 6%. The median time to first onset for increased AST was 15 days (range: 5 days to 1.5 years) and increased ALT was 22 days (range: 7 days to 1.7 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.

Grade ≥ 3 hemorrhagic events occurred in 2.5% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.

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.

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.

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 final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the final dose. Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the final dose.

Common adverse reactions (≥25%) were constipation, hypertension, fatigue, musculoskeletal pain and diarrhea. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased AST, increased ALT, decreased platelets and increased alkaline phosphatase.

Avoid coadministration of GAVRETO with strong CYP3A inhibitors or combined P-gp and strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.

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.

Please click here to see the full Prescribing Information for GAVRETO.

    • GAVRETO Prescribing Information. Genentech, Inc. February 2022.

      GAVRETO Prescribing Information. Genentech, Inc. February 2022.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 18, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 18, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Thyroid Carcinoma V.3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed October 18, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Thyroid Carcinoma V.3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed October 18, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org.

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