Module 6

02/10/2024

Examples Maximise the potential opportunities to extend the new medicinal product

Indirectly broadening treated patient population: • Removing historical barriers, e.g. Tysabri for Disease Modifying Therapy (DMT) switch

Treat different stage of disease: • Moving to earlier line of treatment e.g. Zytiga for m etastatic castration resistant prostate cancer ( mCRPC) w/disease progression to mCRPC asymptomatic / mildly symptomatic • Zykadia, NSCLC, broadened indication to include 1st line therapy Monotherapy / combination therapy: • Victoza: Type II diabetes, combination therapy to monotherapy • Enbrel: RA monotherapy to combination with methotrexate, updated standard of care (SoC)

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

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Example: Keytruda (active pembrolizumab) for Cancer Maximise the potential opportunities to extend the medicinal product

Mechanism of Action: •

Pembrolizumab, is a monoclonal antibody, a protein that has been designed to recognise and block a receptor (‘target’) called PD -1. Some cancers can make a protein (PD-L1) that combines with PD-1 to switch off the activity of certain cells of the immune system (the body’s natural defences) preventing them from attacking the cancer. By blocking PD -1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the immune system’s ability to kill the cancer cells. Initial Marketing Authorisation approved to treat: • Metastatic melanoma, a skin cancer and then later the licence extended to stage III melanoma with combo with ipilimumab

Posology: •

Intravenous injection.

• Keytruda monotherapy the adult dose is either 200 mg every 3-weeks or 400 mg every 6-weeks. • Administered in combination with other cancer medicines, the adult dose is always 200 mg every 3-weeks. • The dose for children is based on their body weight.

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

54

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