Pre-Approval Access Program for Pralsetinib in Patients with Advanced Lung or Thyroid Cancer

Sponsor: Blueprint Medicines Corporation

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04204928

Provider View

This program provides early access to the drug pralsetinib for patients with advanced non-small cell lung cancer (NSCLC) or medullary thyroid cancer (MTC) that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

This global program allows patients with certain advanced cancers to access pralsetinib before it is widely available. The program is open to patients with specific genetic changes in their cancer, such as RET fusion or mutation, who have limited treatment options.

Eligibility Criteria

Inclusion Criteria

  • Have advanced non-small cell lung cancer (NSCLC) with a RET fusion, either untreated or previously treated. If there is another primary mutation, it must be treated first.
  • Have advanced medullary thyroid cancer (MTC) with a RET mutation, either untreated or previously treated.
  • Have an advanced solid tumor with a RET fusion, previously treated with standard care.
  • If previously treated with a RET inhibitor, the cancer must not have worsened, and treatment was stopped due to side effects.
  • Not eligible for or unable to join a current pralsetinib study.
  • Be 12 years or older.
  • Have good organ function and be able to tolerate the treatment.
  • No serious lung disease affecting daily activities.
  • Agree to provide informed consent before starting treatment.
  • Not taking certain medications that affect how pralsetinib works.
  • Not have had recent cancer treatments or major surgery before starting pralsetinib.
  • Women must not be pregnant or breastfeeding and must use effective birth control during and after treatment. Men must also use birth control during and after treatment.

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