Notice: Prescription Drug List (PDL): Multiple Additions

Date: October 21, 2021
Our file number: 21-118202-165

The purpose of this Notice of Amendment is to notify of the addition of the following medicinal ingredients on the Prescription Drug List (PDL) for human and veterinary use:

• Infigratinib or its salts
• Lurbinectedin or its salts or derivatives
• Pemigatinib or its salts
• Propylthiouracil or its salts
• Sacituzumab govitecan
• Sotorasib

The new medicinal ingredients will be added to the PDL as the following:

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.

HALYCIL (propylthiouracil) is indicated for the medical management of hyperthyroidism; in conjunction with radioiodine to hasten recovery while awaiting the effects of radiation; for the control of thyrotoxicosis prior to surgery; and in the management of a thyroid storm in addition to other therapeutic measures.

LUMAKRAS (sotorasib) is indicated for the treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer who have received at least one prior systemic therapy.

PEMAZYRE (pemigatinib) is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

TRODELVY (sacituzumab govitecan) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior therapies, at least one of them for metastatic disease.

TRUSELTIQ (infigratinib) is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

ZEPZELCA (lurbinectedin) is indicated for treatment of adult patients with Stage III or metastatic small cell lung cancer who have progressed on or after platinum-containing therapy.

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
Therapeutic Products Directorate
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca