1.  The whole of this instrument

1 May 2025

1 May 2025

Amivantamab

Solution concentrate for I.V. infusion 350 mg in 7 mL

Injection

Rybrevant

C16402 C16472

Amivantamab

P16472

2100 mg

5

P16402

2100 mg

7

Epcoritamab

Solution concentrate for subcutaneous injection 4 mg in 0.8 mL

Injection

Epkinly

C16405

1

1

Solution for subcutaneous injection 48 mg in 0.8 mL

Injection

Epkinly

C16465 C16466

1

9

C16402

P16402

Amivantamab

Stage IIIB/ IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition.

Compliance with Authority Required procedures

C16405

Epcoritamab

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Induction treatment

The condition must have relapsed, or be refractory to, at least two prior systemic therapies; AND

Patient must have a WHO performance status of no higher than 2; AND

Patient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; OR

Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition; AND

Patient must not be eligible for stem cell transplantation; AND

The treatment must be discontinued in patients who experience disease progression whilst on treatment.

Prior systemic therapy may include autologous stem cell transplant.

Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.

Compliance with Authority Required procedures

C16465

Epcoritamab

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this PBS condition prior to 1 May 2025; AND

The condition must have relapsed, or be refractory to, at least two prior systemic therapies, prior to commencing treatment with this drug; AND

Patient must have had a WHO performance status of no higher than 2 prior to commencing treatment with this drug for this condition; AND

Patient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; OR

Patient must have been unable to receive treatment with CAR-T cell therapy for this condition; AND

Patient must not be eligible for stem cell transplantation; AND

The treatment must be discontinued in patients who experience disease progression whilst on treatment.

Patient must be undergoing treatment with this drug administered weekly in cycles 1 to 3 - prescribe up to 9 repeats; OR

Patient must be undergoing treatment with this drug administered fortnightly in cycles 4 to 9 - prescribe up to 5 repeats; OR

Patient must be undergoing treatment with this drug administered every four weeks in cycles 10 and beyond - prescribe up to 2 repeats.

Prior systemic therapy may include autologous stem cell transplant.

Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.

Compliance with Authority Required procedures

C16466

Epcoritamab

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be discontinued in patients who experience disease progression whilst on treatment.

Patient must be undergoing treatment with this drug administered weekly in cycles 1 to 3 - prescribe up to 9 repeats; OR

Patient must be undergoing treatment with this drug administered fortnightly in cycles 4 to 9 - prescribe up to 5 repeats; OR

Patient must be undergoing treatment with this drug administered every four weeks in cycles 10 and beyond - prescribe up to 2 repeats.

Compliance with Authority Required procedures - Streamlined Authority Code 16466

C16472

P16472

Amivantamab

Stage IIIB/ IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

Patient must have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation; AND

Patient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition; AND

Patient must not have previously received this drug for this condition; OR

Patient must be each of: (i) currently receiving non-PBS-subsidised supply for this drug for this PBS indication, (ii) free of disease progression since commencing non-PBS-subsidised supply; AND

The treatment must be/have been in combination with platinum-based chemotherapy (PBC) where the patient has not previously received systemic therapy for this condition in the metastatic setting, (i.e. used in combination with PBC in the first line setting); OR

The treatment must be the sole PBS-subsidised therapy where the condition has progressed following treatment with platinum-based chemotherapy, (i.e. used as monotherapy in the second line setting).

Compliance with Authority Required procedures