Melanoma

Active Ingredient: Talimogene laherparepvec

Indication for Talimogene laherparepvec

Population group: only adults (18 years old or older)

Talimogene laherparepvec is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.

For this indication, competent medicine agencies globally authorize below treatments:

4000000-400000000 PFU once every 14 days

Route of admnistration

Intratumor

Defined daily dose

4,000,000 - 400,000,000 [PFU]

Dosage regimen

From 4,000,000 To 400,000,000 [PFU] once every 14 day(s)

Loading dose

4,000,000 [PFU]

Maintenance dose

400,000,000 [PFU]

Detailed description

Talimogene laherparepvec is provided in single use vials of 1 mL each in two different concentrations:

  • 106 (1 million) PFU/mL – For initial dose only.
  • 108 (100 million) PFU/mL – For all subsequent doses.

The total injection volume for each treatment visit should be up to a maximum of 4 mL. The initial recommended dose is up to a maximum of 4 mL of talimogene laherparepvec at a concentration of 106 (1 million) PFU/mL. Subsequent doses should be administered up to 4 mL of talimogene laherparepvec at a concentration of 108 (100 million) PFU/mL.

The recommended dosing schedule for talimogene laherparepvec is shown in table 1.

Table 1. Recommended dosing schedule for Talimogene laherparepvec:

Treatment visit Treatment intervalMaximum total injection volumeDose concentrationsPrioritisation of lesions to be injected
Initial - Up to 4 ml106 (1 million) PFU/mlInject largest lesion(s) first.
Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached.
Second3 weeks after initial treatmentUp to 4 ml108 (100 million) PFU/mlFirst inject any new lesions (lesions that may have developed since initial treatment).
Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached.
All subsequent treatment visits (including re-initiation) 2 weeks after previous treatmentUp to 4 ml108 (100 million) PFU/mlFirst inject any new lesions (lesions that may have developed since previous treatment).
Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached.

Determining talimogene laherparepvec dose volume (per lesion)

The volume of talimogene laherparepvec to be injected into each lesion is dependent on the size of the lesion and should be determined according to table 2. The total injection volume for each treatment session should be up to a maximum of 4 mL.

Table 2. Selection of talimogene laherparepvec injection volume based on lesion size:

Lesion size (longest dimension) Talimogene laherparepvec injection volume
>5 cm up to 4 ml
>2.5 cm to 5 cm up to 2 ml
>1.5 cm to 2.5 cm up to 1 ml
>0.5 cm to 1.5 cm up to 0.5 ml
≤0.5 cm up to 0.1 ml

Patients may experience increase in size of existing lesion(s) or the appearance of a new lesion prior to achieving a response. As long as there are injectable lesion(s) remaining, talimogene laherparepvec should be continued for at least 6 months unless the physician considers that the patient is not benefitting from talimogene laherparepvec treatment or that other treatment is required.

Talimogene laherparepvec treatment may be reinitiated if new lesions appear following a complete response and the physician considers that the patient will benefit from treatment.

Dosage considerations

Talimogene laherparepvec is to be administered by intralesional injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable or detectable by ultrasound guidance.

Active ingredient

Talimogene laherparepvec

Talimogene laherparepvec is an oncolytic immunotherapy that is derived from HSV-1. Talimogene laherparepvec has been modified to replicate within tumours and to produce the immune stimulatory protein human GM-CSF. Talimogene laherparepvec causes the death of tumour cells and the release of tumour-derived antigens.

Read more about Talimogene laherparepvec

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