Augtyro

Treatment with AUGTYRO should be initiated and supervised by physicians experienced in the use of anticancer medicinal products. 3 ROS1 testing Patient selection for treatment with repotrectinib, based on ROS1-positive status in NSCLC should be assessed by a CE-marked IVD with the corresponding intended purpose.

1). NTRK testing Patient selection for treatment with repotrectinib, based on NTRK-positive status in solid tumours should be assessed by a CE-marked IVD with the corresponding intended purpose. 1). Posology ROS1-positive non-small cell lung cancer The recommended dose in adults is 160 mg repotrectinib once daily for 14 days, followed by 160 mg repotrectinib twice daily until disease progression or unacceptable toxicity.

NTRK gene fusion-positive solid tumours The recommended dose in adults and paediatric patients 12 year and older is 160 mg repotrectinib once daily for 14 days, followed by 160 mg repotrectinib twice daily until disease progression or unacceptable toxicity.

Missed dose If a dose is missed or if a patient vomits at any time after taking a dose, subsequent doses should be resumed as prescribed. Two doses should not be taken at the same time. 8).

Table 2:

Recommended dose modifications for specific adverse reactions Adverse reactions Severity* Dosage modification Central nervous system effects Intolerable Grade 2 • Withhold until less than or equal to Grade 1 or baseline. • Resume at same or reduced dose, as clinically appropriate.

Grade 3 • Withhold until less than or equal to Grade 1 or baseline. • Resume at reduced dose. Grade 4 • Permanently discontinue. Interstitial lung disease (ILD)/Pneumonitis Any Grade • Withhold if ILD/pneumonitis is suspected. • Permanently discontinue if ILD/pneumonitis is confirmed.

4 Other clinically relevant adverse reactions Intolerable Grade 2 • Withhold until less than or equal to Grade 1 or baseline. • Resume at the same or reduced dose if resolution occurs within 4 weeks. Grade 3 or 4 • Withhold until adverse reaction resolves or improves to recovery or improvement to Grade 1 or baseline.

• Resume at the same or reduced dose if resolution occurs within 4 weeks. • Permanently discontinue if adverse reaction does not resolve within 4 weeks. • Permanently discontinue for recurrent Grade 4 events. 2). Renal impairment No dose adjustment is required for patients with mild or moderate renal impairment.

Summary of the safety profile The most common adverse reactions in adults were dizziness (65%), dysgeusia (57%), constipation (39%), paraesthesia (39%), anaemia (38%), and dyspnoea (31%). 1%). 1%) were the most frequently reported. 2% patients.

Tabulated list of adverse reactions Tables 3 and 4 summarise the adverse reactions reported in patients treated with AUGTYRO in the TRIDENT-1 study in adults (n = 565) and in the CARE study (n = 38) including paediatric patients respectively.

These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 6 months in clinical study. 1 for information on the main clinical study. 5 0 11 % […]

Efficacy across tumour types The benefit of AUGTYRO has been established in single-arm studies encompassing adult patients (N = 88) whose tumours exhibit NTRK gene fusions. Favourable effects of AUGTYRO have been shown based on overall response rate and response duration in a limited number of tumour types.

1). 8). Patients should be advised of these risks with AUGTYRO as they may influence the ability to drive and use machines. 7). 2). Interstitial lung disease (ILD)/Pneumonitis Patients should be advised to report symptoms of ILD/pneumonitis, which may include shortness of breath, cough, wheezing, chest pain or tightness, and haemoptysis.

Patients should be monitored for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. 2). Skeletal fractures Skeletal fractures have been reported in adults and paediatric patients treated with AUGTYRO across clinical studies.

In adult and paediatric patients, some fractures occurred in the setting of a fall or other trauma to the affected area. Radiologic abnormalities possibly indicative of tumour involvement were reported in some patients. , fibula, tibia, or foot).

, pain, changes in mobility, deformity) of fractures should be promptly evaluated. 8). Liver function tests including ALT, AST and bilirubin should be monitored as clinically indicated. Hepatic impairment AUGTYRO has not been studied in patients with moderate or severe hepatic impairment.

2). 3). Women of childbearing potential should have medically supervised pregnancy testing prior to initiating AUGTYRO therapy. Women of childbearing potential must use highly effective contraception during treatment with AUGTYRO and for 2 months following the final dose.

6). 3). Paediatric population Long-term safety data are unavailable on the use of AUGTYRO in paediatric patients 12 years of age and older. 5), which may increase the risk of adverse reactions. Co-administration of AUGTYRO with a strong or moderate CYP3A/P-gp inhibitor should be avoided.

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