Lorlatinib [LOR1]

For anaplastic lymphoma kinase positive advanced non-small-cell lung cancer previously treated with 1st line alectinib 1st line brigatinib or 1st line ceritinib or 1st line crizotinib followed by a 2nd line ALK tyrosine kinase inhibitor therapy (brigatinib or ceritinib) or after disease progression during adjuvant alectinib or within 6 months of completion of adjuvant alectinib where the following criteria have been met:

  1. This application for lorlatinib is being made by and the first cycle of systemic anti-cancer therapy with lorlatinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a locally advanced or metastatic non-small cell lung cancer.
  3. The patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer that carries an anaplastic lymphoma kinase (ALK) rearrangement based on a validated test.
  4. The only TKI treatment that the patient has progressed on is 1st line alectinib or 1st line brigatinib or 1st line ceritinib or 1st line crizotinib followed by one other second generation ALK tyrosine kinase therapy (brigatinib or ceritinib) or after disease progression during treatment with adjuvant alectinib or within 6 months of completion of adjuvant alectinib. Please tick appropriately below as to which type of previous NHS England-commissioned treatment the patient has progressed on:
  • 1st line alectinib or
  • 1st line brigatinib or
  • 1st line ceritinib or or
  • 1st line crizotinib followed by either brigatinib or ceritinib
  • after disease progression during treatment with adjuvant alectinib
  • after disease progression within 6 months of completion of adjuvant alectinib
  1. The patient has not been previously treated with lorlatinib unless lorlatinib has been received as part of any compassionate use scheme and the patient meets all the other criteria set out here.
  2. Lorlatinib will be used only as monotherapy.
  3. The patient has an ECOG performance status of 0 or 1 or 2.
  4. The patient either has no brain metastases or, if the patient has brain metastases, the patient is symptomatically stable prior to starting lorlatinib.
  5. The patient will be treated with lorlatinib until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner.
  6. The prescribing clinician understands the need for regular monitoring of serum cholesterol and triglycerides before and during therapy with lorlatinib.
  7. A formal medical review as to whether treatment with lorlatinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  8. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
  9. Lorlatinib will be otherwise used as set out in its Summary of Product Characteristics.

[NHS funded]{.badge .rounded-pill .bg-success} From: 11 August 2020

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CDF Managed Access: NA

NICE Technology Appraisal: TA628 (13 May 2020)

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