Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC
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This is a global, multicenter, open-label pre-approval access program to provide access to pralsetinib (BLU-667) until such time that pralsetinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.
Condition or disease
Non-Small Cell Lung CancerMedullary Thyroid Cancer
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Layout table for eligibility information
Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Pathologically documented, definitively diagnosed non-resectable or metastatic NSCLC with a RET-fusion or MTC
Patient is not eligible for an ongoing study of pralsetinib or cannot access an ongoing study of pralsetinib
Patient is ≥12 years of age
Patient has received available standard therapies for their disease, or the patient is not an appropriate candidate for one or more of the available standard therapies, and requires systemic treatment for their disease
Patient has adequate vital organ function, including heart, lungs, liver, kidneys, bone marrow, and endocrine, and is expected to tolerate therapy with a tyrosine kinase inhibitor (TKI)
Presence of clinically symptomatic interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis
Patient or legal guardian, if permitted by local regulatory authorities, intends to provide informed consent prior to the start of treatment of pralsetinib
Patient does not require therapy with a concomitant medication that is a strong inhibitor or strong inducer of Cytochrome P450 (CYP) 3A4
Patient has not had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days prior to the first dose of pralsetinib
Women must be willing, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception during pralsetinib administration period and for at least 30 days after the last dose of pralsetinib
Men, if not surgically sterile, must be willing to abstain from sexual intercourse or employ highly effective contraception during pralsetinib administration period and for at least 90 days after the last dose of pralsetinib