ALK-positive Non-Small Cell Lung Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

February 24 22:26 2025
ALK-positive Non-Small Cell Lung Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “ALK-positive Non-Small Cell Lung Cancer (ALK+ NSCLC) Pipeline Insight” report provides comprehensive insights about 6+ companies and 7+ pipeline drugs in ALK-positive Non-Small Cell Lung Cancer pipeline landscape. It covers the ALK-positive Non-Small Cell Lung Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the ALK-positive Non-Small Cell Lung Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the ALK-positive Non-Small Cell Lung Cancer Pipeline. Dive into DelveInsight’s comprehensive report today! @ ALK-positive Non-Small Cell Lung Cancer Pipeline Outlook

Key Takeaways from the ALK-positive Non-Small Cell Lung Cancer Pipeline Report

  • In February 2025:- Novartis Pharmaceuticals:- The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.
  • In February 2025:- Hoffmann-La Roche:- A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer.
  • In February 2025:- Takeda:- All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study. For each participant eligible to continue in the study and to facilitate the remaining participants from Brigatinib-2002 (NCT03535740) to have continued treatment access, the study extension phase may be initiated for participants to continue receiving their randomized study treatment (i.e., brigatinib or alectinib) until they meet at least one of the treatment discontinuation criteria.
  • DelveInsight’s ALK-positive Non-Small Cell Lung Cancer pipeline report depicts a robust space with 6+ active players working to develop 7+ pipeline therapies for ALK-positive Non-Small Cell Lung Cancer treatment.
  • The leading ALK-positive Non-Small Cell Lung Cancer Companies such as Nuvalent, Shouyao Holdings, Xuanzhu Biopharmaceutical, Fochon Pharmaceutical, and others.
  • Promising ALK-positive Non-Small Cell Lung Cancer Therapies such as Lorlatinib, XZP-3621, X-396 (ensartinib), Crizotinib, WX-0593, SAF-189s, and others.

Stay ahead with the most recent pipeline outlook for ALK-positive Non-Small Cell Lung Cancer. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ ALK-positive Non-Small Cell Lung Cancer Treatment Drugs

ALK-positive Non-Small Cell Lung Cancer Emerging Drugs Profile

  • SY-3505: Shouyao Holdings

Ficonalkib (SY-3505) is a highly potent, adenosine triphosphate-competitive, CNS-penetrant, 3rd-gen ALK TKI. In vitro kinase assay revealed that ficonalkib exhibits potent inhibition against both wild-type ALK and a diverse spectrum of mutants observed in patients resistant to 1st- and 2nd-gen ALK TKI, including L1196M, G1202R, F1174L, G1269S, and R1275Q20. The drug exhibits high kinase selectivity and has very weak inhibition on tropomyosin receptor kinase (TRK). The drug is currently being evaluated under Phase III clinical trials for the treatment of NSCLC.

  • APG-2449: Ascentage Pharma

APG-2449 is an orally available, small-molecule FAK/ALK/ROS1 TKI and the first China-developed third-generation ALK inhibitor entering clinical development. The updated results at the ASCO indicated favorable safety and promising antitumor activity in patients with NSCLC, and the preliminary efficacy observed in patients who were resistant to second-generation ALK inhibitors was particularly encouraging. APG-2449 is currently being evaluated in Phase I clinical trial for Non-Small Cell Lung Cancer.

Explore groundbreaking therapies and clinical trials in the ALK-positive Non-Small Cell Lung Cancer Pipeline. Access DelveInsight’s detailed report now! @ New ALK-positive Non-Small Cell Lung Cancer Drugs

ALK-positive Non-Small Cell Lung Cancer Companies

Nuvalent, Shouyao Holdings, Xuanzhu Biopharmaceutical, Fochon Pharmaceutical, and others

ALK-positive Non-Small Cell Lung Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Intra-articular
  • Intraocular
  • Intrathecal
  • Intravenous
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal

ALK-positive Non-Small Cell Lung Cancer Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule

Unveil the future of ALK-positive Non-Small Cell Lung Cancer Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ ALK-positive Non-Small Cell Lung Cancer Market Drivers and Barriers

Scope of the ALK-positive Non-Small Cell Lung Cancer Pipeline Report

  • Coverage- Global
  • ALK-positive Non-Small Cell Lung Cancer Companies- Nuvalent, Shouyao Holdings, Xuanzhu Biopharmaceutical, Fochon Pharmaceutical, and others.
  • ALK-positive Non-Small Cell Lung Cancer Therapies- Lorlatinib, XZP-3621, X-396 (ensartinib), Crizotinib, WX-0593, SAF-189s, and others.
  • ALK-positive Non-Small Cell Lung Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • ALK-positive Non-Small Cell Lung Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on ALK-positive Non-Small Cell Lung Cancer Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ ALK-positive Non-Small Cell Lung Cancer Companies, Key Products and Unmet Needs

Table of Content

  1. Introduction
  2. Executive Summary
  3. ALK Positive Non-Small Cell Lung Cancer : Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. ALK Positive Non-Small Cell Lung Cancer – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. SY-3505: Shouyao Holdings
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Product Name: Company Name
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. APG-2449: Ascentage Pharma
  15. Drug profiles in the detailed report…..
  16. Preclinical Stage Products
  17. Drug Name: Company Name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. ALK Positive Non-Small Cell Lung Cancer – Collaborations Assessment- Licensing / Partnering / Funding
  21. ALK Positive Non-Small Cell Lung Cancer – Unmet Needs
  22. ALK Positive Non-Small Cell Lung Cancer – Market Drivers and Barriers
  23. Appendix

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