A Phase 1 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

Trial Profile

A Phase 1 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Oct 2018

At a glance

  • Drugs BLU-667 (Primary)
  • Indications Adenocarcinoma; Non-small cell lung cancer; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; First in man; Proof of concept; Registrational; Therapeutic Use
  • Acronyms ARROW
  • Sponsors Blueprint Medicines
  • Most Recent Events

    • 30 Oct 2018 According to a Blueprint Medicines media release, based on the additional data of this study, the company plans to submit an NDA for BLU-667 in the first half of 2020. The company recently received a written feedback from the US FDA supporting expedited development of BLU-667.
    • 30 Oct 2018 According to a Blueprint Medicines media release, based on the recent feedback from FDA, the NDA submission will be for separate potential indications: (1) patients with RET-fusion positive NSCLC and papillary thyroid cancer (PTC) who have progressed following prior systemic therapy and (2) patients with RET-mutant medullary thyroid cancer (MTC) who have progressed following treatment with a tyrosine kinase inhibitor.
    • 06 Oct 2018 According to a Blueprint Medicines media release, new updated data from the study were presented (cutoff date of September 14, 2018) in an oral presentation at The 88th Annual Meeting of the American Thyroid Association (ATA).
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