Bayer: Science For A Better Life

United States of America

CGA - Larotrectinib

I. Background 

Bayer Pharmaceuticals’ Medical Education department is committed to funding independent medical education initiatives that help to address important healthcare professional educational gaps and improve patient care.

II. General Information and Requirements

 

CGA Issue Date:October 13, 2025
CGA Due Date:November 14, 2025
Initiation of Program Development:    
 
Q1 2026
Therapeutic Area:

Role of Biomarkers in the Treatment of Patients with Non–Small Cell Lung Cancer (NSCLC) 

Education on biomarker driven testing strategies/appropriate testing modalities 

Role and Clinical Impact of TRK Fusion Testing in Non–Small Cell Lung Cancer (NSCLC) Treatment Algorithms

Implication of TRK pathway aberrations in the pathogenesis of cancer 

Treatment and management of TRK fusion in NSCLC 

Understanding of efficacy and safety profiles of approved TRK inhibitors (TRKi)

How to Prioritize TRKi Treatment 

Emphasizing a multidisciplinary approach to precision medicine and its significance in community and regional oncology settings

Type of Initiative:Online enduring 
Activity Format Examples:Web based enduring module; case presentations included
Primary Target Audience:Oncologists, Pulmonologists, Surgeons, Pathologists, Community HCPs
Geographic Scope:United States
Expected Monetary Range:~ $135,000
How to Submit:1. Review Bayer Pharmaceuticals Grant Guidelines:
https://www.grants-contributions.bayer.com/home/medical-educational-grants

2.Review additional CGA requirements outlined within this document
3. . Submit via Bayer Pharmaceuticals’ online request form:
https://www.grants-contributions.bayer.com/home/medical-educational-grants
NOTE: Please reference ‘ONC Laro CGA’ in the title
Questions:Questions may be submitted to medicaleducation@bayer.com
(please reference ‘ONC Laro CGA’)
Notification Process:Upon Grant Review Committee evaluation and assessment, the requestor is notified of the decision via e-mail to the address entered on the Grant Request Form

III. Proposal Requirements

a. Formal letter of request, including:

  1.  Program title
  2. Brief Program Outline/description
  3. Program development start date
  4. Target release date of program (if applicable)
  5. Rationale and approach to program placement (if applicable)
  6. Anticipated attendance and breakdown by specialty (if applicable)
  7. Amount requested
  8. CME credits offered
  9. Sponsorship structure/rationale 

b. Needs Assessment 

c. Learning Objectives and Educational Gaps: specific, measurable, performance based.

d. Target Audience and Audience Generation: describe the target audience(s) and provide a rationale for how and why this target audience is important to closing the identified healthcare gap. Additionally, describe methods of reaching the target audience(s) including description and rationale for recruitment strategies.

e. Educational Method and Design considers appropriate target audience and learning preferences.

f. Venue (if applicable): describe target venue (i.e., distribution amongst academic institutions, large community hospitals and networks, restaurants, and others).

g. Meeting Placement Strategy and Institution Vetting Process (if applicable)

h. Delivery Format: describe rationale of delivery format

i. Potential Faculty

j. Faculty Recruitment and Training Strategy

k. Program Development Timeline

l. Program Agenda

m. Program Budget: detailed budget with rationale including breakdown of costs with clear calculations.

n. Educational Outcomes: provide a description of the approach to evaluate the reach and quality of program delivery (minimum outcomes: Moore’s levels 1-4).

o. Communication/Activity Update Plan (optional)

p. Completed, recent W-9 form

Provider Justification: 

Copy of most recent accreditation letter and status 

Sample of other program(s) in similar therapeutic areas 

IV. Compliance: grant application must be compliant with ACCME guidelines, free of commercial bias/influence, non-promotional, and fair balanced.

V. Terms and Conditions

  1.  This CGA does not commit Bayer Pharmaceuticals to award a grant or to pay any costs incurred in the preparation of this request.
  2. . Bayer Pharmaceuticals reserves the right to accept or reject any or all applications received as a result of this request or to cancel in part or in its entirety this CGA at any time without prior notification or permission.
     
  3. The grant application must be submitted via Bayer Pharmaceuticals’ online request form https://www.grants-contributions.bayer.com/home/medical-educational-grants.
     
  4. All communications about the CGA must come exclusively to Bayer Pharmaceuticals Medical Education, medicaleducation@bayer.com.
     

VI: Acceptance of a Bayer educational grant indicates that you will: 
 

  • Reconcile grant funding within 60 days of completion of the educational program
  • Permit a Bayer Medical Affairs representative to audit live programs 
     
  • Share activity data and outcomes metrics within 30 days of their availability

REFERENCES:

Management and treatment of metastatic NSCLC 

  • National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 8.2025 – Aug 15, 2025
  • X. Le et al., Factors Associated With Clinical Outcomes in Patients With HER2-Mutant NSCLC Treated With Sevabertinib (BAY 2927088). P3.12.41 WCLC annual meeting 2025.(link)
  • U.S. FDA grants full approval of Vitrakvi (larotrectinib) for adult and pediatric patients with NTRK gene fusion-positive solid tumors. News release. Bayer. April 10, 2025. Accessed April 10, 2025. (link)
    Diagnosis of TRK fusion cancer 
     
  • Khotskaya YB, Holla VR, Farago AF, Mills Shaw KR, Meric-Bernstam F, Hong DS. Targeting TRK family proteins in cancer. Pharmacol Ther. 2017;173:58-66 (LINK).
  • Cocco E, Scaltriti M, Drilon A. NTRK fusion-positive cancers and TRK inhibitor therapy. Nat Rev Clin Oncol. 2018;15(12):731-47 (LINK).
  • Halliday PR, Blakely CM, Bivona TG. Emerging Targeted Therapies for the Treatment of Non-small Cell Lung Cancer. Curr Oncol Rep. 2019;21(3):21 (LINK).
  • Wong D, Yip S, Sorensen PH. Methods for Identifying Patients with Tropomyosin Receptor Kinase (TRK) Fusion Cancer. Pathol Oncol Res. 2020;26(3):1385-99 (LINK). 
     
  • Solomon JP, Linkov I, Rosado A, Mullaney K, Rosen EY, Frosina D, et al. NTRK fusion detection across multiple assays and 33,997 cases: diagnostic implications and pitfalls. Mod Pathol. 2020;33(1):38-46 (LINK).
  • Klink AJ, Kavati A, Gassama A, Kozlek T, Gajra A, Antoine R. Treatment Patterns of Real-World Patients with TRK Fusion Cancer Treated by US Community Oncologists. Target Oncol. 2022;17(5):549-61 (LINK).
  • Yang AT, Laetsch TW. Safety of current treatment options for NTRK fusion-positive cancers. Expert Opin Drug Saf. 2023;22(11):1073-89 (LINK).
  • Repetto M, Chiara Garassino M, Loong HH, Lopez-Rios F, Mok T, Peters S, et al. NTRK gene fusion testing and management in lung cancer. Cancer Treat Rev. 2024;127:102733 (LINK). 
    Kubota Y, Kawano M, Iwasaki T, Itonaga I, Kaku N, Ozaki T, et al. Current management of neurotrophic receptor tyrosine kinase fusion-positive sarcoma: an updated review. Jpn J Clin Oncol. 2025;55(4):313-26 (LINK).
  • Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, et al. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med. 2018;378(8):731-9 (LINK). 
     
  • Tan DS-W, Drilon AE, Lin JJ, Moreno V, Kummar S, Rieke DT, et al. Efficacy and safety of larotrectinib in patients with TRK fusion lung cancer: An updated analysis. Journal of Clinical Oncology. 2025;43(16_suppl):8610-. (LINK).
  • Hong DS, Xu R-H, Shen L, et al. Efficacy and safety of Larotrectinib as first-line treatment for patients with TRK fusion cancer: An updated analysis. Presented at the European Society of Medical Oncology 2024 Annual Meeting; September 13-17, 2024; Barcelona, Spain. (link
     
  • Brose MS; Westphalen CB; Pan X; Bernard-Gauthier V; Kurtinecz M; Guo H; Aris V; Brett NR; Majdi A; Subbiah V; Pennell NA; Kehl KL; Drilon A. Larotrectinib Compared With Real-World Non–Tropomyosin Receptor Kinase Inhibitor Therapies in Patients With Tropomyosin Receptor Kinase Fusion Cancer; JCO Precision Oncology, Volume 9 2025 (link
     
  • Tan et al., Efficacy and safety of larotrectinib in patients with TRK fusion lung cancer: An updated analysis. Abstract # 8610. ASCO 2025; 10.1200/JCO.2025.43.16_suppl.8610  (link)
  • V. Moreno Garcia et al., 79P: Efficacy outcomes of larotrectinib by prior therapy and performance status in patients with TRK fusion lung cancer. ELCC 2025; Journal of Thoracic Oncology, Volume 20, Issue 3, Supplement 1,2025. (link)