LORVIQUA® (Lorlatinib)|Pooled safety data all lines

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Prescribing Information

The information on this website is based on data from adult patients with ALK-positive advanced NSCLC (anaplastic lymphoma kinase positive advanced non small cell lung cancer) treated with LORVIQUA▼(lorlatinib), produced in line with the LORVIQUA (lorlatinib) Summary of Product Characteristics.
LORVIQUA (lorlatinib) Prescribing Information click here.
▼LORVIQUA is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. Adverse event reporting information can also be found at the bottom of the page.

Generally manageable safety profile with largely mild-to-moderate adverse reactions^1,2

Data described here are reflective of the 476 patients treated with LORVIQUA in the Phase 1/2 study of previously treated patients and the Phase 3 CROWN study of previously untreated patients.^1,2

The most common adverse reactions are reported below.

ARs (any grade) occurring in ≥20% of patients treated with LORVIQUA (N=476)¹

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Adverse reaction	All grades	Grades 3 and 4
Hypercholesterolaemia^a	81.1%	18.3%
Hypertriglyceridaemia^b	67.2%	19.3%
Oedema^c	55.7%	2.7%
Peripheral neuropathy^d	43.7%	2.7%
Weight increased	30.9%	10.1%
Cognitive effects^e	27.7%	2.9%
Fatigue^f	27.3%	1.3%
Arthralgia	23.5%	0.8%
Diarrhoea	22.9%	1.5%
Mood effects^g	21.0%	1.5%

In the CROWN study, permanent discontinuations and dose reductions associated with adverse reactions occurred in 7.0% and 21.0% of patients with LORVIQUA and 9.0% and 15.0% with crizotinib, respectively^3,h
35.0% of patients receiving LORVIQUA in the CROWN study reported CNS adverse events, but by the time of analysis 56.0% had resolved and most required no intervention (33.0% resolved without intervention, 17.0% with dose modification)^4,h,
Adverse reactions can be effectively managed with dose modifications and/or standard supportive medical therapy, without affecting the efficacy of LORVIQUA^4,5

Learn more about therapy management

References

Refer to the LORVIQUA Summary of Product Characteristics for the most up-to-date safety profile.

AR=adverse reaction; NSCLC=non-small cell lung cancer; SOC=system organ class.

^aHypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).

^bHypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).

^cOedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling).

^dPeripheral neuropathy (including burning sensation, dysaesthesia, formication, gait disturbance, hypoaesthesia, motor dysfunction, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paraesthesia, peripheral motor neuropathy, peripheral sensory neuropathy, peroneal nerve palsy, sensory disturbance).

^eCognitive effects (including events from SOC nervous system disorders: amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder). Within these effects, terms from SOC nervous system disorders were more frequently reported than terms from SOC psychiatric disorder.

^fFatigue (including asthenia, fatigue).

^gMood effects (including affective disorder, affect lability, aggression, agitation, anger, anxiety, bipolar I disorder, depressed mood, depression, depressive symptom, euphoric mood, irritability, mania, mood altered, mood swings, panic attack, personality change, stress).

^hBased on data from 18-month median follow-up of 149 patients who received LORVIQUA 100 mg once daily in the Phase 3 CROWN trial.³

References

References:

Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics.

Solomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018;19(12):1654-1667.

Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med. 2020;383{21):2018-2029.

Solomon BJ, Bauer TM, Ou SHI, et al. Post hoc analysis of lorlatinib intracranial efficacy and safety in patients with ALK-positive advanced non-small-cell lung cancer from the Phase III CROWN study. J Clin Oncol. Published online May 23, 2022. doi: 10.1200/JCO.21.02278.

Bauer TM, Felip E, Solomon BJ, et al. Clinical management of adverse events associated with lorlatinib. Oncologist. 2019;24(8):1103-1110.

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