Notice: Prescription Drug List (PDL): Multiple Additions

Date: March 28, 2019
Our file number: 19-106933-519

The purpose of this Notice of Amendment is to notify about the additions of axicabtagene ciloleucel, cenegermin, dacomitinib. enasidenib, and lorlatinib to the Prescription Drug List (PDL) for human and veterinary use.

These additions are effective at the time of posting.

Rationale:

A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these drugs require prescription status.

IDHIFA (enasidenib tablets) is indicated for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.

LORBRENA (lorlatinib) is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib.

OXERVATE (cenegermin) ophthalmic solution is indicated for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.

VIZIMPRO (dacomitinib) is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic non small cell lung cancer (NSCLC) with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations.

YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions on these amendments to the Prescription Drug List please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca
Telephone: 343-998-9304
Facsimile: 613-941-1812